Structured Product Labeling (SPL) 

Implementation Guide with Validation 

Procedures

Technical Specifications Document 

This Document is incorporated by reference into the following Guidance Document(s): 

Guidance for Industry – Electronic Submission of Lot Distribution Reports

Guidance to industry - Providing Regulatory Submissions in Electronic Format – Content of Labeling

Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Drug Establishment

Registration and Drug Listing 

Guidance for Industry - SPL Standard for Content of Labeling Technical Questions and Answers 

Guidance for Industry - Indexing Structured Product Labeling (Final)

Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations

Guidance for Industry - Electronic Drug Product Reporting for Human Drug Compounding Outsourcing 

Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Guidance for Industry - Registration of Human Drug Compounding Outsourcing Facilities Under Section 

503B of the FD&C Act

Guidance for Industry - DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale 

Distributors and Third-Party Logistics

Guidance for Industry - Compounding Animal Drugs from Bulk Drug Substances 

Guidance for Industry - Providing Regulatory Submissions in Electronic Format — Content of the Risk 

Evaluation and Mitigation Strategies Document Using Structured Product Labeling 

Guidance for Industry - Format and Content of a REMS Document 

Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry

For questions regarding these technical specifications document, contact spl@fda.hhs.gov. 

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

Center for Drug Evaluation and Research (CDER)

Center for Veterinary Medicine (CVM)

Office of Chief Scientist (OCS)

December 2023
SPL Implementation Guide with Validation Procedures v1

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Structured Product Labeling (SPL) 

Implementation Guide with Validation Procedures

Version 1 Revision 202312080859

1 Introduction................................................................................................................. 9

1.1 Organization ........................................................................................................9

1.2 Validation Procedures..........................................................................................9

2 SPL Documents in General....................................................................................... 10

2.1 SPL Header........................................................................................................10

2.1.1 General...................................................................................................... 10

2.1.2 XML references........................................................................................ 11

2.1.3 Document information.............................................................................. 12

2.1.4 Author Information ................................................................................... 14

2.1.5 Identified Organizations............................................................................ 15

2.1.6 Address ..................................................................................................... 16

2.1.7 Telecommunication Addresses................................................................. 17

2.1.8 Contact Party............................................................................................. 19

2.1.9 “Doing Business As” (DBA) Name.......................................................... 19

2.1.10 Core Document Reference........................................................................ 20

2.1.11 Predecessor Document.............................................................................. 21

2.2 SPL Body...........................................................................................................22

2.2.1 Sections and subsections........................................................................... 22

2.2.2 Text ........................................................................................................... 25

2.2.3 Images....................................................................................................... 30

2.2.4 Highlights.................................................................................................. 31

2.2.5 Product Data Elements Section................................................................. 34

3 Product Data Elements.............................................................................................. 36

3.1 Product in General .............................................................................................37

3.1.2 Equivalence to other Products, Product Source........................................ 40

3.1.3 Additional Identifiers for this Product ...................................................... 42

3.1.4 Ingredient .................................................................................................. 43

3.1.5 Packaging.................................................................................................. 46

3.1.6 Kits, Parts, Components and Accessories................................................. 49

3.1.7 Marketing Category and Application Number ......................................... 54

3.1.8 Marketing status........................................................................................ 59

3.1.9 Characteristics........................................................................................... 64

3.1.10 Combination Product Type ....................................................................... 67

3.1.11 Production Amount................................................................................... 68

3.2 Drug, Biologics, Dietary Supplement and Medical Food Products...................69

3.2.1 Code and Name......................................................................................... 69

3.2.2 Product source........................................................................................... 73

3.2.3 Active ingredient....................................................................................... 74

3.2.4 Active moiety............................................................................................ 76

3.2.5 Reference Ingredient for Strength............................................................. 77

3.2.6 Inactive ingredient .................................................................................... 77

3.2.7 Packaging.................................................................................................. 78
1 Introduction

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3.2.8 Parts........................................................................................................... 79

3.2.9 Marketing Category .................................................................................. 80

3.2.10 Marketing Status and Date........................................................................ 82

3.2.11 DEA schedule ........................................................................................... 83

3.2.12 Solid Oral Drug Product characteristics ................................................... 83

3.2.13 Color ......................................................................................................... 84

3.2.14 Shape......................................................................................................... 85

3.2.15 Size............................................................................................................ 85

3.2.16 Scoring ...................................................................................................... 86

3.2.17 Imprint code .............................................................................................. 86

3.2.18 Flavor........................................................................................................ 87

3.2.19 Image for Solid Oral Dosage Forms......................................................... 87

3.2.20 Route of administration............................................................................. 88

3.3 Device Product...................................................................................................89

3.3.1 Item Code and Name ................................................................................ 89

3.3.2 Additional Device Identifiers.................................................................... 90

3.3.3 [RESERVED] ........................................................................................... 91

3.3.4 Device Ingredient...................................................................................... 91

3.3.5 [RESERVED] ........................................................................................... 91

3.3.6 [RESERVED] ........................................................................................... 91

3.3.7 Device Parts.............................................................................................. 91

3.3.8 Part of Assembly....................................................................................... 92

3.3.9 Regulatory Identifiers ............................................................................... 92

3.3.10 Marketing status and date ......................................................................... 94

3.3.11 Device Characteristics .............................................................................. 94

3.3.12 Reusability ................................................................................................ 95

3.3.13 [RESERVED] ........................................................................................... 96

3.3.14 Sterile Use................................................................................................. 96

3.4 Cosmetic Product...............................................................................................96

3.4.1 Cosmetic Product Item Code .................................................................... 96

3.4.2 Cosmetic Product Name ........................................................................... 96

3.4.3 Cosmetic Product Category ...................................................................... 97

3.4.4 Cosmetic Ingredient................................................................................ 101

3.4.5 Cosmetic Parts ........................................................................................ 102

3.4.6 Marketing status and date ....................................................................... 103

3.4.7 Product Web Page Link .......................................................................... 103

3.4.8 Professional Use...................................................................................... 103

3.4.9 Image of Label for Cosmetics................................................................. 104

3.5 Summary of Product Data Elements................................................................104

4 Drug and Biologics Labeling, Listing, and other Product Submissions................. 105

4.1 Header..............................................................................................................105

4.1.1 Document Type....................................................................................... 105

4.1.2 Labeler information ................................................................................ 106

4.1.3 Registrant information ............................................................................ 106

4.1.4 Establishment information...................................................................... 107

4.1.5 Business Operation Product.................................................................... 111

4.2 Body.................................................................................................................112
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4.2.1 Required Sections ................................................................................... 112

4.2.2 Reporting Period (for certain submissions) ............................................ 114

5 NDC/NHRIC Labeler Code Request...................................................................... 117

5.1 Header..............................................................................................................117

5.1.1 Document type ........................................................................................ 117

5.1.2 Labeler information ................................................................................ 118

5.1.3 Labeler Detail Information ..................................................................... 119

5.1.4 Labeler US Agent ................................................................................... 120

5.1.5 Labeler Operation ................................................................................... 120

5.1.6 FDA-Initiated Labeler Code Inactivation ............................................... 122

5.2 Body - Empty...................................................................................................123

6 Establishment registration....................................................................................... 124

6.1 Header..............................................................................................................124

6.1.1 Document type ........................................................................................ 124

6.1.2 Registrant information ............................................................................ 125

6.1.3 Establishment Information...................................................................... 126

6.1.4 Establishment US agent .......................................................................... 127

6.1.5 Import business....................................................................................... 128

6.1.6 Establishment operation.......................................................................... 129

6.1.7 Business Operation Qualifier.................................................................. 130

6.2 Body - Empty...................................................................................................131

7 Out of Business Notification................................................................................... 132

7.1 Header..............................................................................................................132

7.1.1 Document type ........................................................................................ 132

7.2 Body - Empty...................................................................................................132

8 Pharmacologic Class Indexing................................................................................ 134

8.1 Header..............................................................................................................134

8.1.1 Document type ........................................................................................ 134

8.1.2 Author information ................................................................................. 134

8.2 Body.................................................................................................................135

8.2.1 Pharmacologic Class Indexing Section................................................... 135

8.2.2 Pharmacologic Class Indexing................................................................ 135

8.2.3 Pharmacologic Class Definition ............................................................. 136

9 Dietary Supplement Labeling ................................................................................. 138

9.1 Header..............................................................................................................138

9.1.1 Document Type....................................................................................... 138

9.1.2 Labeler information ................................................................................ 138

9.1.3 Registrant information ............................................................................ 138

9.2 Body.................................................................................................................139

9.2.1 Required Sections ................................................................................... 139

10 Medical Food Labeling....................................................................................... 140

10.1 Header..............................................................................................................140

10.1.1 Document Type....................................................................................... 140

10.1.2 Labeler information ................................................................................ 140

10.1.3 Registrant information ............................................................................ 140

10.1.4 Establishment information...................................................................... 141

10.2 Body.................................................................................................................142
1 Introduction

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10.2.1 Required Sections ................................................................................... 142

11 Medical Device Labeling.................................................................................... 143

11.1 Header..............................................................................................................143

11.1.1 Document Type....................................................................................... 143

11.1.2 Labeler information ................................................................................ 143

11.2 Body.................................................................................................................144

11.2.1 Required Sections ................................................................................... 144

12 Billing Unit Indexing .......................................................................................... 145

12.1 Header..............................................................................................................145

12.1.1 Document Type....................................................................................... 145

12.1.2 Author ..................................................................................................... 145

12.2 Body.................................................................................................................145

12.2.1 Indexing Section ..................................................................................... 145

12.2.2 NDC........................................................................................................ 146

12.2.3 Billing Unit ............................................................................................. 146

13 Generic User Fee Facility Self-Identification..................................................... 148

13.1 Header..............................................................................................................148

13.1.1 Document type ........................................................................................ 148

13.1.2 Registrant information ............................................................................ 148

13.1.3 Facility Information ................................................................................ 149

13.1.4 Facility operation .................................................................................... 150

13.1.5 Business Operation Qualifier.................................................................. 151

13.2 Body - Empty...................................................................................................152

14 [RESERVED] ..................................................................................................... 153

15 Indexing - Product Concept ................................................................................ 154

15.1 Header..............................................................................................................154

15.1.1 Document type ........................................................................................ 154

15.1.2 Author information ................................................................................. 154

15.1.3 Reference Labeling ................................................................................. 154

15.2 Body.................................................................................................................155

15.2.1 Product Concept Indexing Section.......................................................... 155

15.2.2 Abstract Product/Part Concept................................................................ 155

15.2.3 Ingredient ................................................................................................ 156

15.2.4 Abstract Product Concept Code Specification........................................ 157

15.2.5 Abstract Kit Concept Code Specification............................................... 159

15.2.6 Application Product/Kit Concept............................................................ 161

15.2.7 Marketing Category and Application Number ....................................... 162

15.2.8 Application Product/Kit Concept Code Specification ............................ 162

16 Lot Distribution Report....................................................................................... 164

16.1 SPL Header......................................................................................................164

16.1.1 Document type ........................................................................................ 164

16.1.2 Author information ................................................................................. 164

16.1.3 Bulk-Lot Manufacturers.......................................................................... 165

16.2 Body.................................................................................................................166

16.2.2 Data Elements Section ............................................................................ 166

16.2.3 Product Data – Single Licensed Product ................................................ 167

16.2.4 Dosing Specification............................................................................... 168
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16.2.5 Fill Lot .................................................................................................... 168

16.2.6 Bulk Lot(s).............................................................................................. 169

16.2.7 Label Lot(s) (Final Container Lot) ......................................................... 171

16.2.8 Container Data Elements ........................................................................ 172

16.2.9 Containers Distributed ............................................................................ 173

16.2.10 Containers Returned Data ................................................................... 174

16.2.11 Product Data – Kit with Multiple Licensed Products......................... 174

17 [RESERVED] ..................................................................................................... 176

18 Wholesale Drug Distributor/Third-Party Logistics Facility Report ................... 177

18.1 Header..............................................................................................................177

18.1.1 Document type ........................................................................................ 177

18.1.2 Reporter information............................................................................... 177

18.1.3 Facility Information ................................................................................ 178

18.1.4 Facility Business Operation .................................................................... 180

18.1.5 License .................................................................................................... 180

18.1.6 Business Operation Qualifier.................................................................. 184

18.1.7 Approval Disciplinary Action................................................................. 184

18.2 Body - Empty...................................................................................................186

19 40 CFR 180 TOLERANCE ................................................................................ 187

19.1 Header..............................................................................................................187

19.1.1 Document type ........................................................................................ 187

19.1.2 Author Information ................................................................................. 187

19.1.3 Docket Number....................................................................................... 187

19.2 Body.................................................................................................................188

19.2.1 Main Sections.......................................................................................... 188

19.2.2 Sub-Section............................................................................................. 188

19.2.3 Tolerance Specification .......................................................................... 189

19.2.4 Tolerance Range and Commodity .......................................................... 191

19.2.5 Specific Sections and Sub-Sections........................................................ 192

20 Indexing - Biologic or Drug Substance .............................................................. 193

20.1 Header..............................................................................................................193

20.1.1 Document Type....................................................................................... 193

20.1.2 Author ..................................................................................................... 193

20.1.3 Related Document................................................................................... 193

20.2 Body.................................................................................................................194

20.2.2 Index Data Element Section(s) in General.............................................. 195

20.2.3 New (or only) Index Data Element Section............................................ 196

20.2.4 Old Index Data Element Section............................................................. 196

20.2.5 Biologic/Drug Product Information........................................................ 197

20.2.6 Specified Substance ................................................................................ 197

21 Indexing - Warning Letter Alert ......................................................................... 199

21.1 Header..............................................................................................................199

21.1.1 Document Type....................................................................................... 199

21.1.2 Author ..................................................................................................... 199

21.1.3 Reference Labeling ................................................................................. 199

21.2 Body.................................................................................................................200

21.2.1 Indexing Section ..................................................................................... 201
1 Introduction

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21.2.2 Warning Letter Alert Data Element........................................................ 201

21.2.3 Warning Letter Date Element ................................................................. 202

22 [RESERVED] ..................................................................................................... 203

23 Risk Evaluation and Mitigation Strategy (REMS) ............................................. 204

23.1 REMS Document.............................................................................................204

23.1.1 Document type ........................................................................................ 204

23.1.2 REMS Author information ..................................................................... 204

23.1.3 REMS Related Document....................................................................... 205

23.2 Body.................................................................................................................205

23.2.1 REMS Sections and Subsections............................................................ 205

23.2.2 REMS Product ........................................................................................ 206

23.2.3 Marketing Category and Application Number ....................................... 208

23.2.4 REMS Summary..................................................................................... 209

23.2.5 REMS Data Elements............................................................................. 210

23.2.6 REMS Data Elements: Protocol.............................................................. 211

23.2.7 REMS Data Elements:Requirement.......................................................... 212

23.2.8 REMS Approval...................................................................................... 216

23.2.9 REMS Material ....................................................................................... 217

23.2.10 REMS Electronic Resource Information ............................................ 219

24 [RESERVED] ..................................................................................................... 221

25 [RESERVED] ..................................................................................................... 222

26 [RESERVED] ..................................................................................................... 223

27 [RESERVED] ..................................................................................................... 224

28 Blanket No Changes Certification of Product Listing Data................................ 225

28.1 Header..............................................................................................................225

28.1.1 Document type ........................................................................................ 225

28.1.2 Establishment Information...................................................................... 225

28.1.3 NDC/ISBT Product Codes...................................................................... 226

28.1.4 Authorized Agent.................................................................................... 228

28.2 Body - Empty...................................................................................................228

29 Human and Animal Salvaged Drug Products..................................................... 229

29.1 Header..............................................................................................................229

29.1.1 Document type ........................................................................................ 229

29.1.2 Establishment Information...................................................................... 230

29.1.3 Business operation .................................................................................. 230

29.2 Body.................................................................................................................231

29.2.2 Lot number.............................................................................................. 231

29.2.3 Container Data Elements ........................................................................ 233

30 FDA-Initiated Compliance Action – Drug Listing Inactivation......................... 235

30.1 Header..............................................................................................................235

30.1.1 Document type ........................................................................................ 235

30.1.2 Author information ................................................................................. 235

30.1.3 Reference Document............................................................................... 235

30.2 Body.................................................................................................................237

30.2.2 Inactivated or Reactivated Listing’s NDC(s).......................................... 237

30.2.3 Compliance Action – Inactivation and Reactivation Status ................... 238

31 FDA-Initiated Compliance Action – Establishment Registration Inactivation .. 240
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31.1 Header..............................................................................................................240

31.1.1 Document type ........................................................................................ 240

31.1.2 Author information ................................................................................. 240

31.1.3 Inactivated or Reactivated Establishments............................................. 240

31.1.4 Compliance Action – Inactivation and Reactivation Status ................... 242

31.1.5 Reference Document............................................................................... 242

31.2 Body - Empty...................................................................................................243

32 Drug Interactions Indexing ................................................................................. 245

32.1 Header..............................................................................................................245

32.1.1 Document type ........................................................................................ 245

32.1.2 Author information ................................................................................. 245

32.1.3 Reference Labeling ................................................................................. 245

32.2 SPL Body.........................................................................................................246

32.2.2 Sections................................................................................................... 246

32.2.3 Interaction ............................................................................................... 247

32.2.4 Contributing Factor................................................................................. 247

32.2.5 Consequence (Risk) ................................................................................ 248

33 National Clinical Trials Number Indexing ......................................................... 250

33.1 Header..............................................................................................................250

33.1.1 Document type ........................................................................................ 250

33.1.2 Author information ................................................................................. 250

33.1.3 Reference Labeling ................................................................................. 250

33.2 Body.................................................................................................................251

33.2.2 National Clinical Trials Number............................................................. 251

34 [RESERVED] ..................................................................................................... 253

35 Cosmetic Facility Registration............................................................................ 254

35.1 Header..............................................................................................................254

35.1.1 Document type ........................................................................................ 254

35.1.2 Authorized Agent Information (Additional Contact) ............................. 255

35.1.3 Submitter Name and Signature (Legal Authenticator) ........................... 256

35.1.4 Facility Information ................................................................................ 256

35.1.5 Facility US Agent ................................................................................... 258

35.1.6 Parent Company...................................................................................... 258

35.1.7 Small Business Designation.................................................................... 259

35.1.8 Facility Operation ................................................................................... 259

35.2 Body.................................................................................................................259

35.2.2 Cosmetic Product.................................................................................... 260

35.2.3 Responsible Person (Organization)......................................................... 261

36 Cosmetic Product Listing.................................................................................... 262

36.1 Header..............................................................................................................262

36.1.1 Document Type....................................................................................... 262

36.1.2 Labeler (“responsible person” as per label)............................................ 262

36.1.3 Registrant ................................................................................................ 263

36.1.4 Responsible person further details.......................................................... 264

36.1.5 Facility information ................................................................................ 265

36.1.6 Facility Product Link .............................................................................. 267

36.1.7 Submitter Name and Signature (Legal Authenticator) ........................... 268
1 Introduction

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36.2 Body.................................................................................................................269

36.2.1 Required Sections ................................................................................... 269

36.2.2 Cosmetic Product.................................................................................... 269

Appendix......................................................................................................................... 272

List of Tables...............................................................................................................272
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1 Introduction 

Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on 

Clinical Document Architecture and HL7 Reference Information Model (RIM) 

accredited by the American National Standards Institute (ANSI) for the exchange of 

product information. Structured Product Labeling documents include a header and 

body. The header includes information about the document such as the type of 

product, author and versioning. The body of the document includes product 

information in both structured text and data element formats. The United States Food 

and Drug Administration (FDA) uses SPL documents to exchange information 

covering a growing number of product related topics. 

This document provides technical conformance criteria for SPL documents used by 

FDA. This combines the information previously covered in separate implementation 

guide and validation procedures documents.* A link to the latest SPL schema and 

controlled terminology used in SPL and other technical documents may be found on 

the FDA Data Standards Council web site at: https://www.fda.gov/industry/fdaresources-data-standards/structured-product-labeling-resources. 

1.1 Organization

This document is divided into three parts. The first part of this document describes 

the technical conformance criteria that are applicable to header and body of the SPL 

document Independent of the information being exchanged. The second part of the 

document describes product related technical conformance criteria. The third part 

describes the technical conformance criteria applicable to the type of information 

being exchanged.

1.2 Validation Procedures

Detailed validation procedures are presented at the end of most sub-sections and are 

clearly marked with the heading “Validation Procedures.” These procedures can be 

used by humans as check-lists to verify if their submission is correct. The validation 

procedures are written specific and operational so that they may be checked by 

systems processing SPL documents. Each validation procedure has a unique 

paragraph number. These paragraph numbers are generally stable over time, but they 

may change between versions of the document when – rarely – a validation procedure 

is inserted between existing ones; normally, however, new validation procedures are 

appended to the end of their respective sub-sections. 

 

* Instead of 2 documents that both contain details on the structure of SPL files for various purposes with 

examples, explanations and conformance criteria at varying degree of detailing, the combined document is 

a systematic compilation of all such technical information in a new topical organization. As SPL is used for 

an increasing number of different types of products or aspects about products, the old organization became 

difficult to read and to maintain consistently. The new unified implementation guide with topical 

organization combines the discussion of consideration and detailed technical conformance rules for each 

aspect or use of SPL in one place.
2 SPL Documents in General

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2 SPL Documents in General

2.1 SPL Header

2.1.1 General

Validation Procedures 

2.1.1.1 XML is well formed and valid against the schema 

2.1.1.2 There are no data elements and attributes in addition to those described in this 

document 

Certain exceptions apply to this rule, notably any default attribute that validating 

schemas would create are by default part of the document. These need not be stated, 

but cannot reasonably be forbidden. 

<document classCode=“DOC” moodCode=“EVN”/> 

<section ID=“1” classCode=“DOCSECT” moodCode=“EVN”/> 

<characteristic classCode=“OBS” moodCode=“EVN”> 

 <value xsi:type=“ED” representation=“TXT” integrityCheckAlgorithm=“SHA1”/> 

</characteristic> 

<policy moodCode=“EVN”/> 

<approval classCode=“CNTRCT” moodCode=“EVN”/> 

<marketingAct classCode=“ACT” moodCode=“EVN”/> 

<observationMedia classCode="OBS" moodCode="EVN"> 

 <value xsi:type=“ED” representation=“TXT” integrityCheckAlgorithm=“SHA1”/> 

</observationMedia> 

<effectiveTime xsi:type=“IVL_TS” operator=“I”> 

 <low value=“20030203” inclusive=“true”/> 

 <high value=“20040102” inclusive=“true”/> 

</effectiveTime> 

<asContent> 

 <quantity> 

 <denominator value=“1” unit=“1”/> 

 </quantity> 

</asContent> 

<actDefinition> 

 <code nullFlavor="OTH"/> 

</actDefinition> 

<positionNumber nullFlavor=“NA”/> 

<relatedDocument typeCode="REFR"> 

 <relatedDocument> 

 <setId extension="NCT01352845" root="2.16.840.1.113883.3.1077"/> 

 </relatedDocument> 

</relatedDocument> 
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2.1.1.3 There are no spaces in codes

2.1.1.4 Codes do not have a codeSystemName attribute 

2.1.1.5 Display names are case insensitive

2.1.1.6 There are no spaces in id extensions

2.1.1.7 Letters in Globally Unique Identifiers (GUID) are lower case

2.1.1.8 There are no empty or incomplete elements except, in certain circumstances, 

code, title, text, and time (an id has a root, a code has a code system).

2.1.1.9 Characteristics have a class code of “OBS” or no class code at all.

2.1.1.10 There is no confidentiality code on anything but inactive ingredients, identified 

substance, registrant, and assigned establishments outside establishment 

registrations.

2.1.1.11 If there is a confidentiality code, then the code is “B” and the codeSystem is 

“2.16.840.1.113883.5.25” 

2.1.2 XML references

This information includes the location of the current stylesheet for the FDA view of 

the SPL and the location of the current schema. The start of the SPL file is the same 

for every SPL document and is as follows: 

<?xml version="1.0" encoding="UTF-8"?> 

<?xml-stylesheet 

 href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" 

 type="text/xsl"?> 

<document xmlns="urn:hl7-org:v3" 

 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" 

 xsi:schemaLocation="urn:hl7-org:v3 

 https://www.accessdata.fda.gov/spl/schema/spl.xsd"> 

Validation Procedures 

2.1.2.1 XML reference is for version 1.0 and encoding “UTF-8”.

2.1.2.2 There is an xml-stylesheet reference to 

“https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl”.

2.1.2.3 The schemaLocation of the urn:hl7-org:v3 namespace is provided as 

“https://www.accessdata.fda.gov/spl/schema/spl.xsd”. 
2 SPL Documents in General

12 

2.1.2.4 There are no processing instructions other than the xml and xml-stylesheet 

declarations.

2.1.2.5 There are no comments.

2.1.2.6 SPL file name is the document id followed by “.xml”

2.1.2.7 A submission contains only the SPL file whose name ends in ‘.xml’ and, if 

appropriate, associated image files whose names end in '.jpg' except if the 

document types are Wholesale Drug Distributors and Third-Party Logistics 

Facility Report (75030-7) or Risk Evaluation & Mitigation Strategies document 

(82351-8) having associated pdf files whose names end in '.pdf'. 

2.1.2.8 All image files associated with the SPL document are actually referenced from 

that SPL document. 

2.1.3 Document information 

This provides basic information for the identity of the particular document, its type, 

title, date and versioning as a member of a document set. 

Terminology: The SPL document types are from LOINC. This code provides 

information about the subject matter of the document e.g., prescription animal drug. 

<document> 

 <id root="50606941-3e5d-465c-b4e0-0f5a19eb41d4"/> 

 <code code="51725-0" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Establishment registration"/> 

 <title>Establishment Registration</title> 

 <effectiveTime value="20070424"/> 

 <setId root="a30accef-f437-4136-808c-9ed4ada5fcf8"/> 

 <versionNumber value=“1”/> 

• The <id root> is a Globally Unique Identifier (GUID) and is unique for each 

version of the document. Letters used in a GUID are lower case. 

• The <code> is the LOINC code which provides information on the document 

type. 

• The <title> data element is used for the title for the document, if necessary. 

Images are not included in the title. Multiple lines may be used in the title 

with each line separated by the line break <br/> tag. (note: all titles can also 

be as follows: <title mediaType="text/x-hl7-title+xml">).

• The <effectiveTime> provides a date reference to the SPL version including 

the year, month and day as yyyymmdd. 

• The <setId> is a GUID and is a unique identifier for the document that 

remains constant through all versions/revisions of the document. 
SPL Implementation Guide with Validation Procedures v1

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• The <versionNumber> is an integer greater than zero that provides a sequence 

to the versions of the document.

Validation Procedures

2.1.3.1 There is a document id

2.1.3.2 id root is a Globally Unique Identifier (GUID).

2.1.3.3 id does not have an extension.

2.1.3.4 id does not match any other id in the document.

2.1.3.5 id (document id) is unique across all documents, sections and any other ids

2.1.3.6 There is a code

2.1.3.7 Code system is 2.16.840.1.113883.6.1

2.1.3.8 Code comes from the Document type list

2.1.3.9 Display name matches the code

2.1.3.10 There are no figures in the title.

2.1.3.11 There is an effective time with at least the precision of day in the format 

YYYYMMDD

2.1.3.12 There is a set id

2.1.3.13 The set id is a GUID

2.1.3.14 There is a version number

2.1.3.15 Value of version number is a whole number > 0

2.1.3.16 Value of version number is greater than the value of any previously submitted 

version for the same set id

2.1.3.17 The preceding version of this set id has not been replaced by a document with a 

different set id, i.e., this set id has not been referenced as a related document of 

type "replace" (RPLC) from a document with a different set id.
2 SPL Documents in General

14 

2.1.3.18 If the document type is Recombinant Deoxyribonucleic Acid Construct Label

(78745-7) then there the updated document type is Intentional Animal Genomic 

Alteration Label (101437-2). 

2.1.3.19 If the previous document type is Recombinant Deoxyribonucleic Acid Construct 

Label (78745-7), (for the set id) then it has been replaced with Intentional 

Animal Genomic Alteration Label (101437-2). 

2.1.4 Author Information 

The author information is represented as follows: 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

Many times the author information is used to represent details on the businesses 

responsible for the products. This includes the labeler and registrant and 

establishments involved in manufacturing: 

<author> 

 <assignedEntity> 

 <representedOrganization><!-- labeler --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

 <assignedOrganization> <!-- establishment --> 

 <assignedEntity> 

 <assignedOrganization><!-- US agent and importers --> 

The following is a representative coding of the common structures in the header: 

<document> 

 <author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization><!-- labeler --> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <id extension="NDC Labeler Code" root=”2.16.840.1.113883.6.69”/> 

 <name>business name</name> 

 <contactParty> 

 <addr> 

 <streetAddressLine>address</streetAddressLine> 

 <city>city</city> 

 <state>state</state> 

 <postalCode>postal code</postalCode> 

 <country code="country code" 

 codeSystem="1.0.3166.1.2.3">country name</country> 

 </addr> 

 <telecom value="tel:telephone number"/> 

 <telecom value="mailto:email address"/> 

 <contactPerson> 

 <name>contact person name for labeler</name> 

 </contactPerson> 

 </contactParty> 
SPL Implementation Guide with Validation Procedures v1

15 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

 <id extension="DUNS number” root="1.3.6.1.4.1.519.1"/> 

 <name>business name</name> 

 <contactParty><!-- same structure as above --></contactParty> 

 <assignedEntity> 

 <assignedOrganization><!-- establishment --> 

 <id extension="DUNS number" root="1.3.6.1.4.1.519.1"/> 

 <id extension="FDA establishment identifier" 

 root=”2.16.840.1.113883.4.82”/> 

 <name>Establishment name</name> 

 <addr><!-- as above --></addr> 

 <contactParty><!-- as above --></contactParty> 

 <assignedEntity> 

 <assignedOrganization><!-- U.S. agent --> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <name>business name</name> 

 <telecom value="tel: telephone number"/> 

 <telecom value="mailto: email address"/> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C73330" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name"/> 

 </actDefinition> 

 </performance> 

 </assignedEntity> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="establishment business operation code" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name"/> 

 </actDefinition> 

 </performance> 

 </assignedEntity> 

 </assignedOrganization> 

 </assignedEntity> 

 </representedOrganization> 

 </assignedEntity> 

 </author> 

</document> 

2.1.5 Identified Organizations 

Most organizations are identified using Dun and Bradstreet identifiers (DUNS 

numbers). These are identifiers with the root 1.3.6.1.4.1.519.1 and an extension. 

<representedOrganization> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

The only reason for an organization not being identified is if the organization remains 

anonymous but has sub-organizations (e.g., a listing file may not contain any 

registrant information)
2 SPL Documents in General

16 

<representedOrganization> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <name>buiness name</name> 

 <assignedEntity> 

 <assignedOrganization> 

 <!-- pass-through organization without ids or name --> 

 <assignedEntity> 

 <assignedOrganization> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <name>buiness name</name> 

Validation Procedures 

2.1.5.1 One id is a DUNS number with the root 1.3.6.1.4.1.519.1, except if the 

document type is Cosmetic Product Listing (103572-4), Cosmetic Facility 

Registration (103573-2), Cosmetic Facility Registration – Amendment (X8888-

1), Cosmetic Facility Registration - Biennial Renewal (X8888-4), or Cosmetic – 

Update (X8888-5).

2.1.5.2 The id (DUNS number) with the root 1.3.6.1.4.1.519.1 has a 9-digit extension

2.1.5.3 There is a name, except if the document is an FDA-Initiated Compliance Action 

Drug Registration and Drug Listing Inactivation (89600-1), FDA-Initiated 

Compliance Action Drug Registration and Drug Listing Inactivation – Animal 

Drug (99282-6), Cosmetic Product Listing (103572-4), Cosmetic Facility 

Registration (103573-2), Cosmetic Facility Registration – Amendment (X8888-

1), Cosmetic Facility Registration - Biennial Renewal (X8888-4), or Cosmetic – 

Update (X8888-5).

2.1.6 Address

For addresses (addr) the following rules apply 

<addr> 

 <streetAddressLine>1625 29th street</streetAddressLine> 

 <city>Camden</city> 

 <state>NJ</state> <postalCode>08101</postalCode> 

 <country code="USA" codeSystem="1.0.3166.1.2.3">USA</country> 

</addr> 

Validation Procedures 

2.1.6.1 An address has one or two street address line, city, and country. 

2.1.6.2 If there is a country code, then it is an ISO 3-letter country code (code system 

“1.0.3166.1.2.3”). 

2.1.6.3 If there is no code attribute, then the country name may be the code, otherwise 

country is a full country name matching the code. 
SPL Implementation Guide with Validation Procedures v1

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2.1.6.4 If the country is “USA”, then the contact party’s address has a state (2-letter 

abbreviation) and postal code 

2.1.6.5 If the country is “USA”, then the postal code is 5 digits with optionally a dash 

followed by 4 numbers 

2.1.6.6 If the country is not in the postal code validation list, then there is a postal code 

2.1.7 Telecommunication Addresses 

Some elements may have telecommunication addresses. If an element has 

telecommunication addresses it usually allows for a telephone number and an email 

address.

<contactParty> 

 ... 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

 ... 

</contactParty> 

However, there are exceptions noted in the validation procedures. 

Telecommunication addresses are usually provided for an organization’s contact 

party, in which case telephone and email are the common standard. In no case is 

telephone or email missing for contact party. But in some cases a 3rd

telecommunication address can be provided with the FAX number: 

<contactParty> 

 ... 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

 <telecom value="fax:+1-302-123-5433"/> 

 ... 

</contactParty> 

Normally telecommunication addresses are associated with specific contact parties of 

organizations as shown above, such as, for registrant contact party or establishment 

contact party or labeler contact party. However, in some cases, telephone numbers of 

physical facilities can be specified directly without contact party:

<assignedOrganization> 

 ... 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

</assignedOrganization> 

In several Establishment/Facility Registrations/Reporting use cases, traditionally the 

US Agents and Importers have been provided as abbreviated organizations without 

the added complexity of a contact party:
2 SPL Documents in General

18 

<assignedOrganization> 

 ... 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

</assignedOrganization> 

Validation Procedures 

2.1.7.1 There are two <telecom> elements, except if the document type is Lot 

Distribution Data (66105-8) or Indexing - Substance (64124-1) there is one 

telecom element, or for Identification of CBER-Regulated Generic Drug Facility 

(72090-4) or Generic Drug Facility Identification Submission (71743-9) there 

may be a third telecom element, or for any of the Cosmetic Facility Registration 

and Cosmetic Product Listing document types where all telecom elements are 

optional except in facility contact and U.S. Agent. 

2.1.7.2 One telecom value begins with “tel:” and is a telephone number, except if the 

document code is Lot Distribution Data (66105-8) or Indexing - Substance

(64124-1) or any of the Cosmetic Facility Registration and Cosmetic Product 

Listing document types, other than in facility contact party and U.S. Agent. 

2.1.7.3 For telephone numbers, the following general rules apply: 

2.1.7.4 Telephone numbers are global telephone numbers; 

2.1.7.5 Telephone numbers contain no letters or spaces; 

2.1.7.6 Telephone numbers begin with “+”; 

2.1.7.7 Telephone numbers include hyphens to separate the country code, area codes 

and subscriber number; 

2.1.7.8 US telephone numbers have the format +1-aaa-bbb-cccc where “aaa” is the area 

code, and “bbb-cccc” the usual digit grouping of a local phone number. 

2.1.7.9 Telephone numbers have any extensions separated by “;ext=” (see Uniform 

Resource Identifier (URI) for Telephone Numbers RFC 3966). 

2.1.7.10 If there is a semicolon in the telephone number, then it is followed by ext. 

2.1.7.11 One telecom value begins with “mailto:” and encodes an email address, except 

for any of the Cosmetic Facility Registration and Cosmetic Product Listing

document types, other than in facility contact party and U.S. Agent. 

2.1.7.12 an email address is of the simple form <username>@<dns-name>
SPL Implementation Guide with Validation Procedures v1

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2.1.7.13 If there is a third telecom element (fax number), then its value begins with 

“fax:” and its format is the same as for a telephone number.

2.1.8 Contact Party 

For most organizations, a contact party may be specified with a contact person as in 

the following example:

<contactParty> 

 <addr> 

 <streetAddressLine>1625 29th street</streetAddressLine> 

 <city>Camden</city> 

 <state>NJ</state> <postalCode>08101</postalCode> 

 <country code="USA" codeSystem="1.0.3166.1.2.3">USA</country> 

 </addr> 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

 <contactPerson> 

 <name>Bob Jones</name> 

 </contactPerson> 

</contactParty> 

Validation Procedures 

2.1.8.1 The contactParty has an address element (addr), except if the document is Lot 

Distribution Data (66105-8), Wholesale Drug Distributor and Third-Party 

Logistics Facility Report (75030-7), Withdrawal of Wholesale Drug Distributors 

and Third-Party Logistics Facility Report (77573-4), Blanket No Changes 

Certification Of Product Listing (86445-4), Indexing - Substance (64124-1), or 

any of the Cosmetic Facility Registration and Cosmetic Product Listing

document types. 

2.1.8.2 The contactParty has telephone number and email addresses except for any of 

the Cosmetic Facility Registration and Cosmetic Product Listing document 

types. 

2.1.8.3 There is one contact person name, except for any of the Cosmetic Facility 

Registration and Cosmetic Product Listing document types, where the name is 

optional. 

2.1.8.4 If none of the contact party data are provided, then there is no contact party 

element at all.

2.1.9 “Doing Business As” (DBA) Name 

<assignedOrganization> <!-- facility --> 

 ... 
2 SPL Documents in General

20 

 <asNamedEntity> <!-- other “doing business as” name --> 

 <code code="C117113" displayName="doing business as" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <name>A.C.M.E. Logistic</name> 

 </asNamedEntity> 

 <contactParty .../> 

Validation Procedures 

2.1.9.1 There is no “doing business as” (DBA) name element, except if the document 

type is Wholesale Drug Distributors and Third-Party Logistics Facility Report

(75030-7).

2.1.9.2 DBA name has a name element

2.1.10 Core Document Reference

For some SPL documents it is permitted to specify a “core document” reference. A 

document with a core document reference “inherits” all the sections from the 

referenced core document and may override certain top-level sections with its own 

sections. A core document reference is specified as follows: 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="APND"> 

 <relatedDocument> 

 <setId root="20d9b74e-e3d8-4511-9df9-cec2087372fc"/> 

 <versionNumber value="1"/> 

 </relatedDocument> 

 </relatedDocument> 

<component .../> 

</document> 

The reference contains the setId of the referenced core-document. The document and 

the core-document can develop Independently. The core-document may be updated, 

but the reference remains to the latest core-document with the same setId. The version 

number in the reference may be provided to indicate which version of the coredocument was used when at the time the referencing document was created or 

modified. 

Validation Procedures 

2.1.10.1 There is no document id 

2.1.10.2 There is a set id

2.1.10.3 Set id is a GUID
SPL Implementation Guide with Validation Procedures v1

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2.1.10.4 Document set id is the set id of a core-document. 

2.1.10.5 If there is a version number, then it is a whole number > 0. 

2.1.10.6 If there is a version number, then it is less or equal than the version of the 

current core document with that set id. 

2.1.11 Predecessor Document 

Other documents may be merged into this document by providing a reference to the 

other predecessor documents that are replaced by this document. Do not provide a 

reference to the predecessor document under the same set id as the document being 

submitted, as this is implicitly given by the set id and incremented version number of 

this document. Only provide references to documents of different set ids. The 

reference contains only the id of the other predecessor document, code, the setId and 

the version number. All these ids must match the ids of the other documents that had 

previously been submitted. 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="RPLC"> 

 <relatedDocument> 

 <id root="464239de-45c7-4d2f-a89a-45d303f428bd"/> 

 <code code="Other Registration Document Type Code" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="Other Registration Document Type Name"/> 

 <setId root=“9ea75e1e-84ef-4605-89ff-dd08a4c94f40”/> 

 <versionNumber value=“3”/> 

 </relatedDocument> 

 </relatedDocument> 

<component .../> 

</document> 

Validation Procedures 

2.1.11.1 There is an id (document id) 

2.1.11.2 The id (document id) is a GUID 

2.1.11.3 There is a set id

2.1.11.4 The set id is a GUID

2.1.11.5 The set id is different from the present document’s set id. 

2.1.11.6 There is a version number, which is a whole number > 0. 

2.1.11.7 The set id has been previously submitted. 
2 SPL Documents in General

22 

2.1.11.8 Document id and version number match the latest document previously 

submitted under that set id excluding any No Change Notifications. 

2.1.11.9 Document type matches the latest document type previously submitted under 

that set id excluding any No Change Notifications. 

2.1.11.10 The referenced document has not already been replaced by another document.

2.2 SPL Body

The body of the SPL document includes structured text such as product labeling and 

specific data elements such as ingredients. 

<document> <!-- SPL header material --> 

 <component> 

 <structuredBody> <!-- SPL bodyt material --> 

 <component> 

 <section> 

2.2.1 Sections and subsections 

<component> 

 <section> 

 <id root="62abedf9-6bde-4787-beb0-abd214307427"/> 

 <code code="34067-9" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="Indications and Usage"/> 

 <title>Indications and Usage</title> 

 <text>labeling text</text> 

 <effectiveTime value="20070822"/> 

 <component/> 

Sections and subsections have id, title, and code. LOINC codes are used for sections 

and subsections codes. 

The <title>, if necessary, of the sections and subsections and order of the sections and 

subsections in the SPL are used to render the labeling contents. The numbering for 

the sections and subsections are included in the <title> text. 

In the SPL schema, the <structuredBody> element contains multiple <component>s, 

and each <component> contains a <section>. 

Sections are used to aggregate paragraphs into logical groupings. The order in which 

sections appear in an SPL document is the order the sections will appear when 

displayed (rendered) using the standard stylesheet. Major sections defined by the 

appropriate labeling regulations (e.g., 21 CRF 201.56 and 57 for human prescription 

drugs and 201.66 for human over the counter drugs) such as Indications and Usage 

are assigned LOINC codes. Sections that have not been assigned a LOINC code are 
SPL Implementation Guide with Validation Procedures v1

23 

assigned the LOINC code for “SPL Unclassified Section”. Major sections may also 

be defined by parts of a container or carton label (e.g., Principal Display panel). 

<section> 

 <!-- this section’s id, codes --> 

 <text> 

 <!-- actual text content in “narrative block” markup --> 

 </text> 

Each section has a unique identifier (<id>), an <effectiveTime>, and a LOINC code 

(i.e., the <code> element). A section may or may not contain a <title>. 

The human readable content of labeling is contained within the <text> element in the 

<section>. The <section> can be nested to form sub-sections. The schema for 

subsections in SPL requires that the nested <section> tag first be nested inside a 

<component> tag. Use nested sections to relate paragraphs. The section tag applies to 

all of the nested sections. By nesting sections, computer systems can use the section 

tags in SPL to display information useful for the care of patients. If information is not 

associated with the tag, it will not be displayed. 

<section> 

 <!-- this section’s id, codes --> 

 <text> 

 <!-- actual text content in “narrative block” markup --> 

 </text> 

 <component> 

 <section> 

 <!-- subsection content --> 

 </section> 

 </component> 

 <component> 

 <section> 

 <!-- subsection content --> 

 </section> 

 </component> 

</section> 

Using the following principles for markup of text information improves access to 

information in labeling:

• Capture the section heading using the <title> element rather than placing the 

text of the title within the <text> element. This allows computer systems to 

use and display this information properly. 

• Capture the section heading even when the printed label does not include a 

heading. For example, tagging a pregnancy statement as a section in a label 

that does not have a heading for pregnancy is useful. Computer systems will 

be able to use the tag to capture the pregnancy use statement. Omitting the 

<title> would prevent the heading from appearing when the SPL is rendered. 
2 SPL Documents in General

24

• Link different parts of the labeling using the ID attribute to the <section> 

element. For example, <section ID="Clin_Pharm_Section”> serves as the 

target of a <linkHtml> element. Linking to the ID attribute of a section allows 

the link to 'reference' the section entirely, e.g., for retrieval of a whole section 

in a non-browser interface. 

• For container or carton labels, when capturing text and figures outside the 

Drug Facts or equivalent sections, separate the text and figures for each 

concept using <paragraph> tags.

• The order of the placement of information is the content of the package insert, 

the content of the patient information and the carton and container labels with 

images.

Validation Procedures

2.2.1.1 Each section has zero to many subsections

2.2.1.2 Each section and subsection has an id root and no extension

2.2.1.3 id root (section id) is a GUID

2.2.1.4 id does not match any other id in the document

2.2.1.5 id (section id) does not match any other id across all sections, documents, or 

any id other than the id of the same section previously submitted

2.2.1.6 Each section and subsection has a code

2.2.1.7 Code system is 2.16.840.1.113883.6.1

2.2.1.8 Display name matches the code

2.2.1.9 Each section has an effective time with at least the precision of day in the format 

YYYYMMDD, except the SPL Listing Data Elements Section (48780-1) of Lot 

Distribution Data (66105-8), Human Compounded Drug Label (75031-5), 

Animal Compounded Drug Label (77647-6) and Indexing - Warning Letter Alert 

(77288-9) documents, and the SPL Indexing Data Elements Section (48779-3) of 

Indexing - Biologic or Drug Substance (77648-4) and Indexing - Warning Letter 

Alert (77288-9).

2.2.1.10 There are no figures in the title for a section or subsection.

2.2.1.11 The section for SPL Medguide Section (42231-1) and SPL Patient Package 

Insert Section (42230-3) is not a subsection.
SPL Implementation Guide with Validation Procedures v1

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2.2.2 Text 

<section> 

 <text> 

 <paragraph>Lorem ipsum dolor sit amet, consectetur adipisicing elit, 

sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim 

ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip 

ex ea commodo consequat. Duis aute irure dolor in reprehenderit in 

voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint 

occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit 

anim id est laborum.</paragraph> 

 <paragraph>At vero eos et accusamus et iusto odio dignissimos ducimus 

qui blanditiis praesentium voluptatum deleniti atque corrupti quos dolores 

et quas molestias excepturi sint occaecati cupiditate non provident, 

similique sunt in culpa qui officia deserunt mollitia animi, id est laborum 

et dolorum fuga.</paragraph> 

 </text> 

</section> 

The human readable text content of SPL documents is contained within the <text> 

element. The actual content is contained within a <paragraph>, <table>, and/or <list>. 

If a section consists only of nested sections, the <text> tag is not included. Elements 

that can be used within the <text> element to capture the human readable content of 

SPL include paragraphs (<paragraph>), lists (<list>), tables (<table>) and images 

(<renderMultimedia>). Elements permitted as children of the <text> element, used as 

children of the <paragraph> element or within <table> and <list> include superscripts 

(<sup>), subscripts (<sub>), links (<linkHtml>), line breaks (<br>), footnotes 

(<footnote>), footnote references (<footnoteRef>). Images may be included in the 

content of labeling using the <renderMultiMedia> tag. This tag may be used as a 

direct child of <text> for ‘block’ images or as a child of <paragraph> for inline 

images. 

2.2.2.1 Font effects

There are certain aspects of the rendering of SPL that must be specified in the SPL 

source to insure that the content of labeling is formatted correctly when rendered. For 

example: 

<text> 

 <paragraph>The next snippet <content styleCode="bold italics">will appear 

as bold italics</content> in the rendering.</paragraph> 

Will be rendered as: 

The next snippet will appear as bold italics in the rendering. 

The <content styleCode=””> can also be nested, for example:

<text> 

 <paragraph> 

 <content styleCode="bold italics"> will appear as bold 

italics</content> 
2 SPL Documents in General

26 

Can also be represented as: 

<text> 

 <paragraph> 

 <content styleCode="bold”><content styleCode="italics”> will appear as 

bold italics.</content></content> 

The values for <styleCode> for font effect are bold, italics and underline. To assist 

people who are visually impaired, the <styleCode=”emphasis”> is used to prompt 

computer screen reader programs to emphasize text such as text in a box warning. 

The bold, italics and underline font effects may be used together with each other and 

the emphasis styleCode. For example, <content styleCode=”bold”><content 

styleCode=”emphasis”> </content></content> will appear as bold and will be 

emphasized by the screen reader programs. 

A special styleCode is used for recent major changes (see below). 

2.2.2.2 Symbols and special characters

Special characters can be included in the text. Superscripts and subscripts are 

accomplished using the <sup> and <sub> tags. Because the SPL encoding is UTF-8, 

any Unicode character can be included as is. Unicode references may also be inserted 

as either &#dddd; where dddd is the Unicode value in decimal notation or � 

where dddd is the Unicode value in hexadecimal notation. The font used in the 

standard stylesheet is a Unicode font assuring that most Unicode characters will be 

rendered correctly if viewed by a browser supporting this font. The only prohibited 

characters in XML that can not be directly used are less-than “<” (because SPL XML 

tags begin with it) and ampersand “&” (because XML entity references begin with it). 

Use of these two symbols must be replaced by the XML entity references <. and 

& respectively. For example, “<paragraph>The mean for group 1 was < 13.

</paragraph>” will render as “The mean for group 1 was <13.” and “D&C 

Yellow #10” will render as “D&C Yellow #10”. 

2.2.2.3 Footnotes 

The SPL schema includes a specific footnote element <footnote>. Footnotes are 

rendered automatically by the standard SPL stylesheet. <footnoteRef> is used to refer 

to another (usually earlier) footnote. For example, “<footnote ID=”testNote”>This is 

the footnote content</footnote>” will generate the following footnote at the 

appropriate end of a section. “6 This is footnote content” 

The <footnoteRef> element with the appropriate IDREF attribute, e.g., <footnoteRef 

IDREF=”testNote”/> will display the footnote reference in the text corresponding to 

the footnote with the same ID, e.g., in this example footnote 6. 

Footnotes are rendered by the default stylesheet using Arabic numbers (e.g., 1,2 3,).

Within tables, footnotes are rendered using footnote marks in the series: * † ‡ § ¶ # ♠ 
SPL Implementation Guide with Validation Procedures v1

27 

♥ ♦ ♣, effectively separating numbered footnotes within general text and footnotes 

within tables. Footnotes within tables are rendered at the bottom of the table. 

2.2.2.4 Lists

All lists are marked up using the <list> tag, and each item in a list is marked with an 

<item> tag. The ‘listType’ attribute identifies the list as ordered (numbered) or 

unordered (bulleted). The default numbering and bulleting are controlled by the 

stylesheet.

<text> 

 <paragraph>Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed 

do eiusmod tempor incididunt ut labore et ...</paragraph> 

 <list listType="ordered" styleCode="BigRoman"> 

 <item>Lorem ipsum dolor sit amet,</item> 

 <item>consectetur adipisicing slit</item> 

 </list> 

 <paragraph>At vero eos et accusamus et iusto ...</paragraph> 

</text> 

Lists featuring a standard set of specialized markers (standard specialized lists) can be 

created using the styleCode attribute with the <list> element. Options available for 

ordered lists are:

• Arabic (List is ordered using Arabic numerals: 1, 2, 3) 

• LittleRoman (List is ordered using little Roman numerals: i, ii, iii)

• BigRoman (List is ordered using big Roman numerals: I, II, III)

• LittleAlpha (List is order using little alpha characters: a, b, c)

• BigAlpha (List is ordered using big alpha characters: A, B, C) 

For example: <list listType="ordered" styleCode="LittleRoman">

For unordered lists the following options exist: 

• Disc (List bullets are simple solid discs: ●)

• Circle (List bullets are hollow discs: ○)

• Square (List bullets are solid squares: ■)

For example: <list listType=”unordered” styleCode=”Disc”>

In addition to the standard specialized lists, user-defined characters are also permitted 

as markers by nesting <caption> within the <item> tag. Note that any character, XML 
2 SPL Documents in General

28

entity, or Unicode symbol, may be used in the <caption>, and that the <caption> for 

each <item> are not restricted to the same character.

For example: <item><caption>*</caption> the asterisk is used as item marker 

here.<item>

2.2.2.5 Tables

Tables can be created with the full structure (header (e.g., for column names), body 

(e.g. for the rows of the table) and footer e.g. for table footnotes)). The element 

<tbody> is required for an SPL table while the elements <thead> and <tfoot> are 

optional in the SPL schema. The structure will display a standard typographical table 

with rules between the caption (table title) and head, the head and body, and the body 

and <tfoot>. If a <tfoot> element is included and footnotes are present in a table, then 

footnotes are rendered after the existing content of the <tfoot> element. 

It is recommended to always start with a standard table (i.e., <thead> and <tbody> 

elements) and test to see whether the rendering is unambiguous and interpretable. It is 

important that the table communicate labeling content not that it duplicates the 

presentation in word processed or typeset versions of the package insert. In the 

unusual situation where additional formatting is needed, the rule styleCode specified 

or certain attributes may be used to modify the table. 

The rule codes are as follows (note that the control names are case sensitive).

• Rule on left side of cell is Lrule

• Rule on right side of cell is Rrule

• Rule on top of cell is Toprule

• Rule on bottom of cell is Botrule

Note: More than one rule control may be used in a cell, e.g., <td styleCode 

code=”Botrule Lrule”>Cell content </td>.

Rule control codes should be used only when necessary for the interpretability of the 

table. Use of these codes may result in overriding the default rules for tables. Rather 

than setting the rule for each cell, table rules may also be controlled according to 

entire rows or columns by use of the styleCode attributes with <col>, <colgroup>, 

<thead>, <tfoot>, <tbody> and <tr> elements.

To make rowgroups appear with horizontal rules, use the styleCode attribute 

"Botrule" with the appropriate <tr> element. The Botrule value is rarely needed on 

the <td> element.
SPL Implementation Guide with Validation Procedures v1

29

The preferred method for using vertical rules is to define colgroup with 

styleCode="Lrule” or “Rrule" (or both). Only if this does not yield the desired 

vertical rule should the Lrule or Rrule code value with styleCode attributes on the 

<td> or <th> element itself be used. Note: In general, vertical rules should not be 

used. Good typography for tables means using few vertical rules.

To merge cells vertically and horizontally, the rowspan and colspan attributes should 

be used on the <td>element.

To determine the width of a table, the width attribute may be used on the <table> 

element and to determine the width of a table column, the width attribute may be used 

on the <col> and <colgroup> elements.

For horizontal alignment, the preferred method for aligning cell content within the 

margins is to use <col align=”.. ”/> in the <colgroup> element, though this can be 

used in the <colgroup> element as well. Valid values for align are “left”, “center”, 

“right”, “justify” (for full justification of contents within the cells), and “char” (for 

character alignment within the cells). Using the <col align=”.. ”/> markup ensures 

that the contents for all cells in the column share the same alignment.

For vertical alignment, the valign attribute can be used within cells. For cases in 

which the cell alignment must be different from other cells in the column, align is 

also available as an attribute on the other table elements, including <td>. 

Markup for table footnote is rendered in the <tfoot> tag. This element does not need 

to be included in SPL; the standard stylesheet will include a <tfoot> tag if a 

<footnote> element is present within either the <thead> or <tbody> sections. A 

<tfoot> section should be included in SPL only if there is additional information other 

than footnotes that needs to be rendered in this section.

For table text spacing, in some instances, the use of a “tab” or text indentation is 

desirable in a given table cell. In an SPL document, this effect is achieved by using 

the nonbreaking space ( ) as if it were a “tab” space. As the following snippet 

of XML shows, two nonbreaking spaces were used to offset the word “Male” from 

the margin: <td>  Male</td>. The nonbreaking space can also be used 

to keep text in a table from breaking inappropriately due to browser resizing. 

2.2.2.6 Hypertext links

SPL offers hypertext linking capabilities generally similar to those found in the 

HTML specification.

Links are specified by the <linkHtml> construct, where the value for the href attribute 

of <linkHtml> (the target of the link) is the ID attribute value of a <section>, 

<paragraph>, <table>, <list>, <content>,<renderMultimedia> element. The stylesheet 

does not support the styleCode attribute of the <linkHtml> element; if a styleCode is 
2 SPL Documents in General

30 

needed for a link, this should be coded via the <content> element within the link as 

with other text.

2.2.2.7 Recent major changes in labeling text

SPL offers a notation to identify recent major changes in the labeling text including 

table elements <table> and table data <td>. The recent major text is tagged using the 

<content styleCode=“xmChange”>. For example, 

<text>This is an example of text that is not changed.<content 

styleCode=“xmChange”>This is an example of text that is a recent major 

change</content>This is an example of changed text that is not considered a 

recent major change</text> 

Validation Procedures 

2.2.2.8 Text is enclosed under <paragraph>, <list>, or <table> elements.

2.2.2.9 The number of table data (<td>) elements is identical to the number of column 

(<col>) elements in each table (<table>).

2.2.3 Images 

The SPL schema uses <observationMedia> elements to identify graphic files to be 

rendered at the locations where they are referenced by <renderMultiMedia> elements 

in the <section>. In other words, an image in an SPL will be rendered wherever it is 

referenced by the renderMultimedia markup, no matter where the observationMedia 

markup appears. The referencedObject attribute of the renderMultiMedia element 

identifies the corresponding observationMedia instance by means of its ID identifier 

such as <renderMultiMedia referencedObject="MM1"/>

<section> 

 <text> 

 <paragraph>...</paragraph> 

 <renderMultiMedia referencedObject="MM1"/> 

 <paragraph>...</paragraph> 

 </text> 

 <component> 

 <observationMedia ID="MM1"> 

 <text>descriptive text</text> 

 <value xsi:type="ED" mediaType="image/jpeg"> 

 <reference value="drug-01.jpg"/> 

 </value> 

 </observationMedia> 

 </component> 

</section> 

The <observationMedia> element does not contain the graphics file, but instead 

points at the file. The <reference> value is the file name. The file name should not 

include spaces. The observationMedia identifies the graphic media type (i.e., JPEG). 

In addition, the observationMedia element includes the text description of the image 
SPL Implementation Guide with Validation Procedures v1

31

used by screen reader software for visually impaired users. This is included in the 

<text> child of <observationMedia>. Note also that observationMedia is always 

contained within a <component> element as illustrated.

For image placement, if an image is a block image (i.e., should appear in its own 

space), insert the renderMultimedia tag between <paragraph> elements. If an image is 

inline (i.e., should appear alongside text), insert the renderMultimedia tag in the text 

of a <paragraph> as appropriate. Inline images are expected to be uncommon and 

basically represent symbols that cannot be represented by Unicode characters. In 

addition, <caption> are not applicable for inline images since these are not offset 

from the surrounding text.

The SPL stylesheet does not perform any resizing graphics or changing the resolution 

of graphics files. Thus, all images are rendered in the browser as-is, with all 

characteristics of the actual graphic file itself. To ensure that a graphic will appear as 

desired, it is very important that the graphic file is edited to a dimension appropriate 

for its presentation within the browser. If this is not done, the appearance of the 

graphic may not be consistent with the narrative content reducing the readability of 

the file. JPEG image file type using appropriate pixels per inch for images for 

viewing in a browser using the standard stylesheet.

Validation Procedures

2.2.3.1 There is text

2.2.3.2 Value xsi:type is as above

2.2.3.3 Media type is image/jpeg

2.2.3.4 Reference value is the file name for a valid image

2.2.3.5 Size of image file is less than 1 MB

2.2.3.6 File is a JPEG image and the name has the extension “.jpg” 

2.2.3.7 Image components are referenced at least once in the text of any section.

2.2.3.8 Image reference in text has an image “observationMedia” element with a 

matching ID in the same document.

2.2.4 Highlights

The actual Highlights of a rendered SPL are constructed from four sources: 

“boilerplate” text rendered directly from the stylesheet, information from data 

elements inserted into the boilerplate text, <title> in the header which includes the 

drug names, dosage form, route of administration, controlled substance symbol and 
2 SPL Documents in General

32 

year of initial US approval, and text blocks corresponding to each major highlights 

part (Highlights text). Highlights section titles are derived from the FPI section 

LOINC codes. The Highlights text is captured for the following sections: 

Microbiology, Boxed Warning, Recent Major Changes, Indications and Usage, 

Dosage and Administration, Dosage Forms and Strengths, Contraindications, 

Warnings and Precautions, Adverse Reactions, Drug Interactions and Use in Specific 

Populations. 

The text blocks for Highlights are coded with the <excerpt> <highlight> elements of 

the major section of labeling in which they are contained. 

<section> 

 <excerpt> 

 <highlight> 

 <text>...</text> 

For example, the Highlights for Indications and Usage are located with the 

Indications and Usage section of the labeling. The Highlights text is placed under the 

main section and not under subsections. The following is an example: 

<component> 

 <section> 

 <id root="47ef84cd-8314-48c3-8ee2-bdff3087f83f"/> 

 <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" 

 displayName="warnings and precautions section"/> 

 <title>5 WARNINGS AND PRECAUTIONS</title> 

<excerpt> 

 <highlight> 

 <text> 

 <list listType="unordered"> 

 <item>Aplastic anemia has been observed in 8% of recipients and 

is irreversible in the majority of patients who experience this. (<linkHtml 

href=”#Section_5.1”>5.1</linkHtml>)</item> 

 <item>Monitor for hematological adverse reactions every 2 weeks 

through the second month of treatment (<linkHtml 

href=”#Section_5.2”>5.2</linkHtml>)</item> 

 </list> 

 </text> 

 </highlight> 

 </excerpt> 

<component> 

 <section ID="Section_5.1"> 

 <id root="a857689e-9563-43c0-a244-8a6d5a25966a"/> 

 <title>5.1 Aplastic anemia</title> 

 <text> 

 <paragraph>Aplastic anemia has been observed in.....</paragraph> 

 </text> 

 </section> 

 </component> 

 </section> 

</component> 

This example illustrates the following principles:
SPL Implementation Guide with Validation Procedures v1

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a. The <text> block for the Highlights is included as the <excerpt> <highlight> 

<text> children of the respective section. In the example above, the text block 

rendered in the highlights section is the child of the “Warnings and Precautions” 

section.

b. The coding of the highlights text block is not in a subsection. 

c. The text block is rendered similar to any other text block, although in a location 

separate from its actual position in the rendered SPL document. 

d. Links to the section or subsection where the primary content exists are explicitly 

entered in the Highlights text block.

e. Section numbering is included in the title of sections and subsections (e.g., ‘5’ and 

‘5.1’, above).

Highlights and labeling boilerplate items include:

• Statement -“Highlights of Prescribing Information”

• Highlights section titles

• Patient counseling statement with information taken from FPI section LOINC 

codes for patient information sections, specifically information for patient 

section (34076-0), SPL Medguide section (42231-1), SPL patient package 

insert section (42230-3) and SPL supplemental patient material (38056-8)

• Revision date is taken from the effective time

• Full Prescribing Information: Contents

• Statement – “Full Prescribing Information”

Validation Procedures

2.2.4.1 There may be excerpts (sections with highlights text).

2.2.4.2 Excerpts occur only in the following sections: Boxed Warning Section (34066-

1), Recent Major Changes Section (43683-2), Indications & Usage Section

(34067-9), Dosage & Administration Section (34068-7), Dosage Forms & 

Strengths Section (43678-2), Contraindications Section (34070-3), Warnings 

and Precautions Section (43685-7), Adverse Reactions Section (34084-4), Drug 

Interactions Section (34073-7), Use in Specific Populations Section (43684-0), 

and Microbiology Section (49489-8)

2.2.4.3 If there is an excerpt, then it only has highlight text.
2 SPL Documents in General

34 

2.2.4.4 An excerpt in the Adverse Reactions Section (34084-4) includes the statement: 

"to report suspected adverse reactions" and "1-800-332-1088" (different 

telephone number for documents of type Vaccine Label (53404-0).

2.2.4.5 If there are highlights excerpts, then the title for the SPL file includes the text 

string (without the quotation marks): “These highlights do not include all the 

information needed to use” “see full prescribing information for” and “Initial 

U.S. Approval” 

2.2.5 Product Data Elements Section 

Currently most of the time the product data elements are in a separate section of their 

own followed by the content of labeling sections that contain only text and no data 

elements. Product data element section and other special data elements sections are 

described in Section 3 below; this section describes the features used from the free 

text (so called “narrative”) part of the SPL documents.

<document> <!-- SPL header material here --> 

 <component> 

 <structuredBody><!-- SPL body material here --> 

 <component> 

 <section> <!-- Product data element section --> 

 <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <subject> 

 <manufacturedProduct> 

 <!-- product data elements --> 

 </manufacturedProduct> 

 </subject> 

 </section> 

 </component> 

 <!-- Other content of labeling material --> 

 <component> 

 <!-- ... --> 

The beginning of the product data elements is as follows

<component> 

 <section> 

 <id root="e13a985b-f706-a5c8-e8ef-73891eb1c697"/> 

 <code code="48780-1" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <effectiveTime value="20070424"/> 

 <subject> 

 <manufacturedProduct> 

Validation Procedures 

2.2.5.1 Code, code system and display name are as above
SPL Implementation Guide with Validation Procedures v1

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2.2.5.2 There is one or more product, except in Human Compounded Drug Label

(75031-5) and Animal Compounded Drug Label (77647-6) documents.

2.2.5.3 There is an effective time with at least the precision of day in the format 

YYYYMMDD.

2.2.5.4 There is only one product data element section.
3 Product Data Elements

36

3 Product Data Elements

This section describes with examples in general the capabilities of the product data 

elements that are currently implemented in the scope of this Implementation Guide. 

More specific sections follow with more detail and more specific guidelines and 

validation procedures. These subsequent sections may constrain and detail what is 

described here, but may also introduce details not described here in general. In case of 

discrepancies, the later specific ruling preempts the general description given here.

Terminology: 

• FDA terminology is used for the proprietary, non proprietary and ingredient 

name.

• National Drug Codes (NDC) System is used for 

o NDC Labeler Code (4 or 5 digit code (e.g., 0001 or 11111)), to register 

the labeler prefix,

o NDC Product Code (8 or 9 characters beginning with the NDC Labeler 

Code separated by a hyphen from the product segment of the code 

(e.g., 0001-0001 or 11111-001 or 11111-0001)) for products 

Independent of packaging, and 

o NDC Package Code (10 characters beginning with the NDC Product 

Code separated by a hyphen from the package segment of the code 

(e.g., 0001-0001-01, 11111-001-01 or 11111-0001-1)) for packaged 

products. 

• NDC System is also used for identifiers for the National Health Related Item 

Code (NHRIC)

o NHRIC Labeler Code (4 or 5 digit code), 

o NHRIC Product Code (8, 9 or 10 digits beginning with the NHRIC 

Labeler Code separated by a hyphen from the product segment of the 

code and 

o NHRIC Package Code (10 digits beginning with the NDC Product 

Code separated by a hyphen from the package segment of the code). 

• ISBT-128 site and product codes are for licensed minimally manipulated cell 

products. 

• GS1 GTIN and HIBCC codes are used for device item codes. 

• FDA Substance Registration System (SRS) is used for the ingredient and 

active moiety Unique Ingredient Identifier (UNII). 

• The FDA submission tracking system is used for application numbers. 

• The National Cancer Institute Thesaurus (NCIt) is used for dosage form, 

product characteristics, DEA schedule, unit of presentation, route of 

administration and equivalent codes. 

• The Unified Codes for Units of Measure (UCUM) is used for the unit of 

measure. 

• HL7 confidentiality code “B” is for business confidential information. 

• FDA Product Classification codes are for device and cosmetic products.
SPL Implementation Guide with Validation Procedures v1

37

• Codes from the OTC Monograph are used for monograph IDs.

• Cosmetic Listing Number (CLN) assigned to each Cosmetic Product Name 

identified in each initial and updated technically valid cosmetic product SPL 

file for which a Listing Number has not been previously assigned. The 

Cosmetic Listing Number Format:

o Cosmetic Listing Number (CLN) Prefix: 53 -

o Product Segment of CLN: XXXXXX-XXXXXX

o OID for Cosmetic Product Listing is 2.16.840.1.113883.3.9848.

3.1 Product in General

Among the product data elements that are always used are item code and name. These 

are children of <manufacturedProduct>. 

Item Code is a unique identification of this product description whether or not the 

item code is printed on the product itself. Item codes must conform to the ISO 15459 

system of codes. National Drug Code (NDC), National Health Related Item Code 

(NHRIC), GS1 GTIN, HIBCC all conform to ISO 15459. All these have in common 

that they are composed of a company prefix (e.g. NDC labeler segment) followed by 

the item reference that is assigned by the owner of the company prefix to create a 

unique item code. As long as the item code is unique, the digits (and letters) in it need 

not convey any other information. 

Names: When specific manufactured or marketed products are described, the name is 

the proprietary name as it appears on the label divided between <name> and <suffix>. 

The <name> is the initial portion of the proprietary name describing the ingredients 

without any other descriptors including trademarks and dosage forms. If necessary, 

<suffix> is used for descriptors such as “extended release”. When using the <suffix>, 

a space after the proprietary name is added as necessary. Non-proprietary or generic 

names of drugs are found in the <genericMedicine><name> element. Device type 

codes and descriptions use <asSpecializedKind>. 

A brief description is added in the <desc> element that states succinctly the kind of 

device. This text should be brief to be able to list it in short summary listings. While 

the text can be up to 512 characters in length, it should normally be much shorter so 

that it will be useful for listing in tables. A device also has a device-nomenclature 

code in the <asSpecializedKind> element. This code comes from the FDA Product 

Classification terminology. 

Cosmetic Listing Number (CLN): Associated with each product name. For Code 

system name ‘Cosmetic Product Listing’ assigned Code system OID is 

‘2.16.840.1.113883.3.9848’.

Marketing category and product type: The type of product is indicated by the 

“Marketing Category”.

Table 1: Marketing Category and Product Type
3 Product Data Elements

38

Code Type Display Name

C73583 Drug ANADA

C73584 Drug ANDA

C132333 Drug Approved drug product manufactured Under Contract

C95600 Drug Approved drug product manufactured Under Contract

C73585 Biologic BLA

C73626 Drug Bulk ingredient

C98252 Drug Bulk Ingredient for Animal Drug Compounding

C96793 Drug Bulk Ingredient for Human Prescription Compounding

C73588 Drug Conditional NADA

C86952 Dietary Supplement Dietary Supplement

C94795 Drug Drug for Further Processing

C80438 Device Exempt device

C73590 Drug Export only

C80440 Device Humanitarian Device Exemption

C75302 Drug IND

C92556 Drug Legally Marketed Unapproved New Animal Drugs for 

Minor Species

C86964 Medical Food Medical Food

C175238 Drug or Biologic Multi-Market Approved Product

C73593 Drug NADA

C73594 Drug NDA

C73605 Drug NDA authorized generic

C132334 Drug OTC monograph drug product manufactured Under 

Contract

C95601 Drug OTC monograph drug product manufactured Under 

Contract

C200263 Drug OTC Monograph Drug

C80441 Device Premarket Application

C80442 Device Premarket Notification

C175462 Drug or Biologic SIP Approved Drug

C101533 Drug unapproved drug for use in drug shortage

C73627 Drug unapproved drug other

C132335 Drug Unapproved drug product manufactured Under Contract

C95602 Drug Unapproved drug product manufactured Under Contract

C73614 Drug unapproved homeopathic

C73613 Drug unapproved medical gas

C181659 Drug Outsourcing Facility Compounded Human Drug Product 

(Exempt From Approval Requirements)

C96966 Drug Emergency Use Authorization

The following is an example for a drug product:
SPL Implementation Guide with Validation Procedures v1

39 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="NDC Product Code" codeSystem="2.16.840.1.113883.6.69"/> 

 <name>proprietary name <suffix>suffix to name</suffix></name> 

 <formCode code="dose form code" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name"/> 

 <asEntityWithGeneric> 

 <genericMedicine> 

 <name>non proprietary name</name> 

 </genericMedicine> 

 </asEntityWithGeneric> 

 </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <!-- possibly approval number --> 

 <code code="C73594" displayName="NDA" 

 codeSystem="2.16.840.1.113883.3.26.1.1" /> 

 <!-- possibly other attributes in the marketing category --> 

 </approval> 

 </subjectOf> 

 </manufacturedProduct> 

</subject> 

The following is an example for a device:

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="Device Item Code" codeSystem="Item Code System"/> 

 <name>proprietary name <suffix>suffix to name</suffix></name> 

 <desc>Brief description of product (up to 512 characters)</desc> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="product classification code" 

 codeSystem="2.16.840.1.113883.6.303" 

 displayName="display name"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

 </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <!-- possibly approval number --> 

 <code code="C80441" displayName="Premarket Application" 

 codeSystem="2.16.840.1.113883.3.26.1.1" /> 

 <!-- possibly other attributes in the marketing category --> 

 </approval> 

 </subjectOf> 

 </manufacturedProduct> 

</subject> 

Validation Procedures 

3.1.1.1 There is an Item Code, except for part products not requiring an Item Code or if 

the document type is Human Compounded Drug Label (75031-5), Animal 

Compounded Drug Label (77647-6), Indexing - Biologic or Drug Substance
3 Product Data Elements

40 

(77648-4) or Risk Evaluation & Mitigation Strategies (82351-8), Indexing – 

Risk Evaluation & Mitigation Strategies (82353-4), FDA-Initiated Compliance 

Action Drug Registration and Drug Listing Inactivation (89600-1), FDAInitiated Compliance Action Drug Registration and Drug Listing Inactivation – 

Animal Drug (99282-6), Cosmetic Product Listing (103572-4), Cosmetic 

Facility Registration (103573-2), Cosmetic Facility Registration – Amendment

(X8888-1), Cosmetic Facility Registration - Biennial Renewal (X8888-4), or 

Cosmetic – Update (X8888-5). 

3.1.1.2 General rules about the Item Code are:

3.1.1.3 Code system is 2.16.840.1.113883.6.69 (NDC, NHRIC), 1.3.160 (GS1), 

2.16.840.1.113883.6.40 (HIBCC), 2.16.840.1.113883.6.18 (ISBT 128), or 

2.16.840.1.113883.3.9848 (Cosmetic Product Listing Number) except if the 

document type is Indexing – Product Concept (73815-3). 

3.1.1.4 Code is compliant with the code system’s allocation rules. 

3.1.1.5 There is a name, i.e., proprietary name of the product as used in product labeling 

or in the catalog, except if the document type is Indexing - Product Concept

(73815-3) or FDA-Initiated Compliance Action Drug Registration and Drug 

Listing Inactivation (89600-1), or FDA-Initiated Compliance Action Drug 

Registration and Drug Listing Inactivation – Animal Drug (99282-6), or if the 

marketing statusCode is new or cancelled. 

3.1.1.6 If the document type is Human Compounded Drug Label (75031-5) then there 

may be an item code.

3.1.1.7 The product item code has not been previously submitted in an NDC reservation 

of a different document set id with marketing status new. 

3.1.2 Equivalence to other Products, Product Source 

The following is for referencing information already submitted for a source drug: 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="NDC Product Code" codeSystem="2.16.840.1.113883.6.69"/> 

 <name>proprietary name <suffix>suffix to name</suffix></name> 

 <asEquivalentEntity classCode="EQUIV"> 

 <code code="C64637" codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <definingMaterialKind> 

 <code code="source NDC Product Code" 

 codeSystem="2.16.840.1.113883.6.69"/> 

 </definingMaterialKind> 

 </asEquivalentEntity> 
SPL Implementation Guide with Validation Procedures v1

41 

This is a special case of referencing other products for various purposes. Another 

purpose is for products that are updated with improvement, where it may be useful to 

indicate a succession to a previous version of the product identified by the item code 

of the predecessor product. This can be done using the equivalence relationship with 

<asEquivalentEntity> with a different Role code as in Table 2: 

<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

<asEquivalentEntity classCode="EQUIV"> 

 <code code="C?????" codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <definingMaterialKind> 

 <code code="81234567890008" codeSystem="1.3.160"/> 

The following equivalence codes are defined:

Table 2: Equivalence Codes

Equivalence Code

Same C64637

Predecessor Product pending

Product source may be specified under a product 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <asEquivalentEntity> 

or under parts 

<part> 

 <partProduct> 

 <asEquivalentEntity> 

Validation Procedures 

3.1.2.1 As equivalent entity class code is as above

3.1.2.2 If there is a classCode, it is “EQUIV”.

3.1.2.3 Code and code system are as above, except if the document type is Indexing - 

Product Concept (73815-3) or Indexing - Warning Letter Alert (77288-9).

3.1.2.4 Source NDC product code (Defining material kind code) matches an NDC 

product code (Item Code) in an SPL file with a different set id. 

3.1.2.5 Equivalent Item Code is not the same as the Item Code for the product 
3 Product Data Elements

42 

3.1.2.6 Equivalent Item Code is not the same as the Item Code for another equivalence 

stated for this product, except if the document type is Indexing - Product 

Concept (73815-3).

3.1.2.7 The Source NDC product code is not currently inactivated by an FDA Agency 

Initiated Compliance Action.

3.1.2.8 There is only one product source per product. 

3.1.2.9 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) then there is no product source. 

3.1.2.10 If the source NDC product code (Defining Material Kind Code) matches an 

NDC product code (Item Code) with a marketing end date in an SPL file with a 

different set id, then the repackager’s/relabeler’s NDC product code is 

associated with a marketing end date which is identical or prior to the marketing 

end date for the source NDC product code (Defining Material Kind Code). 

3.1.3 Additional Identifiers for this Product 

A multitude of other identifiers may be assigned to some products by various parties, 

manufacturers, distributors, wholesalers, regulators. These identifiers are of a varying 

quality in terms of control for uniqueness and meaning. They may be unique item 

codes from other ISO 15459 item code systems, or they may be less well defined 

codes such as “model number” or “catalog number” etc. While those “model 

numbers” or “catalog numbers” are often not safe for referencing, such identifiers are 

customer facing and may encode minor product variants, which would be recognized 

by customers and hence listing such identifier cross references can aid in finding the 

correct item code.

<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

<asIdentifiedEntity classCode="IDENT"> 

 <id extension="other identifier" root="other identifier root"/> 

 <code code="other identifier type code" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="model number"/> 

HL7 requires any identifier to be made globally unique, therefore submitters must 

acquire an OID of their own through any of several sources. Submitters must not 

allow conflicting assignments of model numbers among their own products. 

Submitters can still create unique identifiers from these model numbers by giving 

different root OIDs for each kind of identifiers that may be in conflict. Once a 

company has acquired a root OID this root OID can be freely sub-divided. For 

example, ACME Fine Devices Inc. may have acquired the OID 

2.16.840.1.113883.3.98765 from the HL7 registry. ACME then decided to use a subbranch .2 under their OID to manage model numbers for the models from models 
SPL Implementation Guide with Validation Procedures v1

43 

release before 2007 and sub-branch .5 for models released after 2007. There is no 

specific rule that must be obeyed when sub-dividing OIDs as long as it results in the 

concatenation of model number code and codeSystem OID to be a unique identifier. 

Different types of such identifications may be assigned different codes from the NCI 

Thesaurus for Model Number, Catalog Number and possibly other “types” of 

numbers: 

Table 3: Miscellaneous Identifier Types

Identifier Type Code Description

Model Number C99286 the exact model number found on the device label or 

accompanying packaging.

Catalog Number C99285 the exact number as it appears in the manufacturer's catalog, 

device labeling, or accompanying packaging

Reference 

Number

C99287 any secondary product identifier

3.1.4 Ingredient 

Ingredients may be specified for products 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <ingredient/> 

and parts. 

<part> 

 <partProduct> 

 <ingredient/> 

Ingredient information includes the class code specifying the type of ingredient (e.g., 

active, inactive), code, name, and strength, and possibly active moiety name(s) and 

identifier and a reference ingredient name and identifier. 

<ingredient classCode=”class code including basis of strength”> 

 <quantity> 

 <numerator value="value" unit="UCUM code"/> 

 <denominator value="value" unit=" UCUM code"/> 

 </quantity> 

 <ingredientSubstance> 

 <code code="UNII" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>active ingredient name</name> 

 <activeMoiety> 

 <activeMoiety> 

 <code code="UNII" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>active moiety name</name> 

 </activeMoiety> 

 </activeMoiety> 
3 Product Data Elements

44 

 <asEquivalentSubstance> 

 <definingSubstance> 

 <code code="UNII" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>reference substance name</name> 

 </definingSubstance> 

 </asEquivalentSubstance> 

 </ingredientSubstance> 

</ingredient> 

Devices too may have active ingredients as discussed above (device with embedded 

ingredient.) 

The ingredient element is also used to specify that a product “may contain” a certain 

substance (e.g., latex, milk, nuts) or that it “does not contain” such substances (e.g., 

wheat gluten).

“May contain” is expressed by specifying the ingredient using the class code 

“CNTM” without any quantity; e.g., product may contains latex: 

<ingredient classCode="CNTM"> 

 <ingredientSubstance> 

 <code code="2LQ0UUW8IN" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>NATURAL LATEX RUBBER</name> 

“Does not contain” is expressed by specifying the ingredient using the class code 

“CNTM” without a quantity with numerator 0 (zero); e.g. product is gluten free: 

<ingredient classCode="CNTM"> 

 <quantity> 

 <numerator value="0" unit="1"/> 

 <denominator value="1" unit="1"/> 

 </quantity> 

 <ingredientSubstance> 

 <code code="1534K8653J" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>WHEAT GLUTEN</name> 

If the ingredient comes from a product (such as in Human Compounded Drug Labels, 

75031-5) one can specify the product item code for the ingredient as a source product, 

or, when the product item code is an NDC, called simply the ingredient’s source 

NDC.

<ingredient classCode=“ingredient class code e.g., ACTI(M/B/R)”> 

 ... 

 <ingredientSubstance .../> 

 <subjectOf> 

 <substanceSpecification> 

 <code code=“Source NDC” codeSystem=“2.16.840.1.113883.6.69”/> 

 </substanceSpecification> 

 </subjectOf> 

</ingredient> 
SPL Implementation Guide with Validation Procedures v1

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Active ingredient class codes are “ACTIB”, “ACTIM”, and “ACTIR”. See Section 

3.2.3 for details on active ingredients. Other ingredient classes exist aside from active 

ingredients. Drugs have inactive ingredients (also called “excipients”) described in 

Section 3.2.6. Devices, dietary supplements, cosmetics and certain compounded drugs 

may also have ingredients whose class is not further specified other than that it is an 

“ingredient” (INGR):

<ingredient classCode="INGR"> 

 <ingredientSubstance> 

 <code code="PQ6CK8PD0R" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>ASCORBIC ACID</name> 

Validation Procedures 

3.1.4.1 There is a class code.

3.1.4.2 There may be a strength with a numerator and denominator 

3.1.4.3 Numerator and denominator have a value greater than zero and a unit, except the 

numerator when the ingredient class code is “CNTM”.

3.1.4.4 Unit comes from the UCUM units of measures list

3.1.4.5 For percentages numerator unit is not 1, instead use a volume unit for volume 

fractions and a mass unit for mass fractions. 

3.1.4.6 The denominators values and units for all ingredients in this product are the 

same.

3.1.4.7 There is an ingredient code with code and code system, except for cosmetics

product listings, where the code is optional. 

3.1.4.8 Code system is 2.16.840.1.113883.4.9 except if the document type is Human 

Compounded Drug Label (75031-5.) 

3.1.4.9 The same ingredient substance code (UNII) is not used more than once per 

product. 

3.1.4.10 There is an ingredient name.

3.1.4.11 Name matches the code (UNII)

3.1.4.12 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) then there are source(s) of the active 

ingredient(s) which are identified using an item code (ingredient source NDC), 

or as ingredients (with the classCode “INGR”) such as a dietary supplement 

ingredients. 
3 Product Data Elements

46 

3.1.4.13 If the document type is not Human Compounded Drug Label (75031-5) or 

Animal Compounded Drug Label (77647-6) then there is no ingredient source 

product item code (ingredient source NDC). 

3.1.4.14 Ingredient source product item code (source NDC) has been previously 

submitted (i.e. is a known listed product). 

3.1.4.15 If the document type is Animal Compounded Drug Label (77647-6), then the 

source of the active ingredient (bulk or finished drug(s)) identified by the item 

code (source NDC product code) has that same active ingredient as the 

compounded drug product. 

3.1.4.16 If the document type is, Animal Compounded Drug Label (77647-6), then the 

source of the active ingredient (bulk or finished drug(s)) identified by the item 

code (source NDC product code) can consist of more than one active ingredient, 

and in that case all the source's active ingredients must be mentioned in the 

compounded drug product. 

3.1.5 Packaging 

The packaging includes the quantity of product in the package and the package type 

and Package Item Code (such as NDC Package Code or other Item Code for the 

package). 

Packaging may be specified for the product, 

<manufacturedProduct> 

 <manufacturedProduct> 

 <asContent/> 

for parts,

<part> 

 <partProduct> 

 <asContent/> 

and for packages. 

<asContent> 

 <containerPackagedProduct> 

 <asContent/> 

The format for packaging specification is:

For example,
SPL Implementation Guide with Validation Procedures v1

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<asContent> 

 <quantity> 

 <numerator value="value" unit="UCUM code"/> 

 <denominator value="1"/> 

 </quantity> 

 <containerPackagedProduct> 

 <code code="Package Item Code" codeSystem="2.16.840.1.113883.6.69"/> 

 <formCode code="value" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name"/> 

 </containerPackagedProduct> 

</asContent> 

Validation Procedures 

3.1.5.1 A product may have an “as content” (package information) element (optional for 

parts)

3.1.5.2 There is a quantity, except if the document type is FDA-Initiated Compliance 

Action Drug Registration and Drug Listing Inactivation (89600-1), or FDAInitiated Compliance Action Drug Registration and Drug Listing Inactivation – 

Animal Drug (99282-6); see Section 30. 

3.1.5.3 Quantity (for package information) includes a numerator and denominator. 

3.1.5.4 Numerator (for package amount) has a value greater than zero and a unit 

3.1.5.5 If the product has parts, then the initial numerator value and unit is “1” 

3.1.5.6 Unit of the numerator (for package amount) of the initial package is the same as 

the units for the denominators of all the ingredient quantities (strengths) 

3.1.5.7 Unit of the numerator (for package amount) of an outer package is the same as 

the unit for the denominator of the quantity of the inner package 

3.1.5.8 Denominator has value 1 and either no unit or unit “1”. 

3.1.5.9 There is a form code, except if the document type is FDA-Initiated Compliance 

Action Drug Registration and Drug Listing Inactivation (89600-1), or FDAInitiated Compliance Action Drug Registration and Drug Listing Inactivation – 

Animal Drug (99282-6); see Section 30. 

3.1.5.10 Code system for form code is 2.16.840.1.113883.3.26.1.1. 

3.1.5.11 Display name matches form code

3.1.5.12 There is a package item code with code and code system for outermost package, 

except for parts or if the document type is Human Compounded Drug Label

(75031-5) or Animal Compounded Drug Label (77647-6).
3 Product Data Elements

48

3.1.5.13 If document type is Cellular Therapy (60684-8), Plasma Derivative (60683-0), 

Vaccine Label (53404-0), then there is a package item code with code and code 

system for the inner, unit of use package, except if the inner package is wrapped 

into a pouch (C43200) the item code may be on the pouch level. 

3.1.5.14 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) and if there is a product NDC, then there 

should be an outermost package NDC.

3.1.5.15 If the package item code has been previously submitted, then the package form 

code and quantity value and unit are the same as in the most recent submission 

for this item code.

3.1.5.16 If the package item code is mentioned elsewhere in the document, then the 

package form code and quantity value and unit are the same and the content of 

both packages have an Item Code that is the same.

3.1.5.17 Package item code does not match any other package item code in the same 

package hierarchy.

3.1.5.18 If the package item code is an NDC/NHRIC (i.e., if the root is 

“2.16.840.1.113883.6.69”), then the following procedures apply:

3.1.5.19 NDC/NHRIC package item code is 10 digits (excluding any hyphens).

3.1.5.20 NDC/NHRIC package item code contains three segments divided by hyphens.

3.1.5.21 The first two segments of the NDC/NHRIC package item code matches the 

NDC/NHRIC product/item code.

3.1.5.22 The third segment of the NDC/NHRIC package item code is numeric.

3.1.5.23 If the package item code is an ISBT 128 code (i.e., if the root is 

“2.16.840.1.113883.6.18”), then the following procedures apply:

3.1.5.24 ISBT 128 package item code has three segments divided by hyphens.

3.1.5.25 The first two segments of the ISBT 128 package item code matches the ISBT 

128 Product Item Code.

3.1.5.26 The third segment contains two digits.

3.1.5.27 Package Item Code code system is 2.16.840.1.113883.6.69 (NDC, NHRIC), 

1.3.160 (GS1), 2.16.840.1.113883.6.40 (HIBCC), 2.16.840.1.113883.6.18 

(ISBT 128), or 2.16.840.1.113883.3.9848 (Cosmetic Product Listing Number).
SPL Implementation Guide with Validation Procedures v1

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3.1.5.28 Package Item Code is compliant with the code system’s allocation rules.

3.1.5.29 If the document type is not for Bulk Ingredient (53409-9), Bulk Ingredient – 

Animal Drug (81203-2), Drug for Further Processing (78744-0), OTC Animal 

Drug Label (50577-6), OTC Type A Medicated Article Animal Drug Label

(50576-8), OTC Type B Medicated Feed Animal Drug Label (50574-3), OTC 

Type C Medicated Feed Animal Drug Label (50573-5), Prescription Animal 

Drug Label (50578-4), VFD Type A Medicated Article Animal Drug Label

(50575-0), VFD Type B Medicated Feed Animal Drug Label (50572-7), VFD 

Type C Medicated Feed Animal Drug Label (50571-9), Cosmetic (58474-8), 

Dietary Supplement (58476-3), Medical Food (58475-5), Human Compounded 

Drug Label (75031-5), Animal Compounded Drug Label (77647-6), Lot 

Distribution Data (66105-8), Licensed Vaccine Bulk Intermediate Label (53406-

5), Recombinant Deoxyribonucleic Acid Construct Label (78745-7), Intentional 

Animal Genomic Alteration Label (101437-2), FDA-Initiated Compliance 

Action Drug Registration and Drug Listing Inactivation (89600-1), FDAInitiated Compliance Action Drug Registration and Drug Listing Inactivation – 

Animal Drug (99282-6), or Animal Cells, Tissues, and Cell and Tissue Based 

Product Label (98075-5), then a combination product type characteristic is on 

the inner-most packaging. 

3.1.6 Kits, Parts, Components and Accessories 

Products may be combined in various ways such as: 

• Drug kit with a device part

• Device kit with a drug part

• Device with an embedded drug 

• Drug in a delivery device

• Products sold separately but meant to be used together 

Kits and Parts: When products have more than one part, each part is described under 

<partProduct>. The total amount of the part in the product is included as follows: 

<part> 

 <quantity> 

 <numerator value="total amount of part in product" unit="UCUM code"/> 

 <denominator value="1"/> 

 </quantity> 

 <partProduct> 

 <!-- same as above for drug or device. --> 

Currently, when a drug product has parts, it is considered a Kit indicated by the 

formCode for KIT:
3 Product Data Elements

50 

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="11234560012349" codeSystem="1.3.160"/> 

 <name>Easy-Go PreciFuse PorterPump Kit</name> 

 <formCode code=" C47916" displayName="KIT" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <part><!-- ... --> 

Device products may also be kits (in this case a device with FDA product 

classification code but also with formCode specifying KIT. However, devices 

themselves may also be specified with parts, such as distinguishing component 

options or field replaceable parts, in this case the top-level device need not have a 

formCode for KIT:

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="item code of device" codeSystem="code system OID"/> 

 <name>name of device</name> 

 <desc>brief description of device</desc> 

 <asSpecializedKind ... product classification for device ... /> 

 <part> 

 <quantity> 

 <numerator value="1"/> 

 <denominator value="1"/> 

 </quantity> 

 <partProduct> 

 <code code="item code of part" codeSystem="code system OID"/> 

 <name>name of part</name> 

 <desc>brief description of device part</desc> 

Drug Kit with a Device Part: This sort of kit has been known from SPL R4 as well, 

examples being drugs sold as a kit with an applicator device. 

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="NDC code of kit" codeSystem="2.16.840.1.113883.6.69"/> 

 <name>name of kit</name> 

 <formCode code="C47916" displayName="KIT" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <asEntityWithGeneric .../> 

 <part> 

 <quantity> 

 <numerator value="amount of this part’s content in one kit" 

 unit="unit for amount"/> 

 <denominator value="1"/> 

 </quantity> 

 <partProduct> 

 <code code="NDC code of drug part" 

 codeSystem="2.16.840.1.113883.6.69"/> 

 <name>name of drug part</name> 

 <formCode code="form code of drug part" 

 displayName="form name of drug part" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <ingredient ... /> 
SPL Implementation Guide with Validation Procedures v1

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 <asContent> 

 <quantity> 

 <numerator value="amount of this part in its package" 

 unit="unit of amount"/> 

 <denominator value="1"/> 

 </quantity> 

 <containerPackagedProduct> 

 <code code="NDC code of part’s package" 

 codeSystem="2.16.840.1.113883.6.69"/> 

 <formCode code="package type" 

 displayName="package type name" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </containerPackagedProduct> 

 </asContent> 

 </partProduct> 

 </part> 

 <part> 

 <quantity> 

 <numerator value="amount of this device part in one kit"/> 

 <denominator value="1"/> 

 </quantity> 

 <partProduct> 

 <code code="item code of this device part" 

 codeSystem="item code system OID"/> 

 <name>name of device part</name> 

 <desc>description of device part</desc> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="product classification code of device part" 

 codeSystem="2.16.840.1.113883.6.303" 

 displayName="display name of device part"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

 </partProduct> 

 </part> 

Device Kit with a Drug Part:

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="item code of device kit" 

 codeSystem="item code system OID"/> 

 <name>name of kit</name> 

 <desc>brief description of kit</desc> 

 <formCode code="C47916" displayName="KIT" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="product classification code of kit" 

 displayName="display name of kit" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

 <part> 

 same as device part above 

 </part> 
3 Product Data Elements

52 

 <part> 

 same as drug part above 

 </part> 

Device with an embedded drug: For example, a drug eluting stent with an 

embedded active ingredient. Notice that such products do not involve kits and parts: 

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="device item code" 

 codeSystem="device item code system OID"/> 

 <name>device name</name> 

 <desc>brief description</desc> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="product classification code of device" 

 displayName="display name of device" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

 <ingredient classCode="ACTIB"> 

 <quantity .../> 

 <ingredientSubstance> 

 <code code="UNII code of active ingredient" 

 codeSystem="2.16.840.1.113883.4.9"/> 

 <name>paclitaxel</name> 

Drug in a delivery device: For example, drug in pre-filled syringe. Note that the 

syringe filled with the drug is a different product than the empty syringe. Hence it 

would not be correct to put the item code for the empty syringe on the one filled with 

the drug. In fact, since the pre-filled syringe already has (or should have) an NDC 

code, there is no need for another item code for it. However, one may want to refer to 

the item code for the empty syringe as a generalization of the filled syringe:

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="NDC code drug" 

 codeSystem="2.16.840.1.113883.6.69"/> 

 <name>name of drug</name> 

 <formCode code="form code of drug" 

 displayName="form display name of drug" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <ingredient classCode="ACTIB"> 

 <!-- active ingredient --> 

 </ingredient> 

 <asContent> 

 <quantity> 

 <numerator value="amount of drug in prefilled device" 

 unit="unit of amount"/> 

 <denominator value="1"/> 

 </quantity> 
SPL Implementation Guide with Validation Procedures v1

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 <containerPackagedProduct> 

 <code code="NDC code for prefilled device" 

 codeSystem="2.16.840.1.113883.6.69"/> 

 <formCode code="form code of prefilled device" 

 displayName="form display name of prefilled device" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="item code of empty device" 

 codeSystem="item code system of empty device"/> 

 <desc>brief description of empty device</desc> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="product classification code of device" 

 displayName="display name of device" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

Products sold separately but meant to be used together: when products are used 

together but packaged separately, the data element <asPartOfAssembly> is used to 

identify the other product. The products could be drugs or devices. 

<manufacturedProduct> 

 <manufacturedProduct> 

 <code code="item code of device" codeSystem="code system OID"/> 

 <name>name of device</name> 

 <desc>brief description of device</desc> 

 <asSpecializedKind ... product classification for device .../> 

 <asPartOfAssembly> 

 <quantity> 

 <numerator value="1"/> 

 <denominator value="1"/> 

 </quantity> 

 <wholeProduct><!-- this is the assembly, but has no identifier --> 

 <part> 

 <quantity> 

 <numerator value="1"/> 

 <denominator value="1"/> 

 </quantity> 

 <partProduct> 

 <code code="item code of accessory component" 

 codeSystem="code system OID"/> 

 <name>name of accessory component</name> 

 <desc>brief description of accessory component</desc> 

 <asSpecializedKind ... product classification for device .../> 

Parts may be specified for the product,

<manufacturedProduct> 

 <manufacturedProduct> 

 <part/> 

and for part products. 
3 Product Data Elements

54 

<part> 

 <partProduct> 

 <part/> 

Validation Procedures 

3.1.6.1 If the product form code is for a Kit (C47916), then there is one or more parts. 

3.1.6.2 Each part has an overall quantity 

3.1.6.3 If there is an “as content” (package information) data element in the part, then 

the numerator unit is the same as the numerator unit for the “as content” data 

element

3.1.6.4 If there is no “as content” (package information) data element in the part, then 

the numerator unit is 1, except if the document type is Indexing - Product 

Concept (73815-3) or marketing status is new or cancelled. 

3.1.6.5 If there is a code, then the general rules for product code apply (see 3.1.1.1ff).

3.1.6.6 There is a name, except if the document type is Indexing - Product Concept

(73815-3).

3.1.6.7 Procedures for source, ingredients, characteristics and packaging are the same as 

for products without parts 

3.1.6.8 If the product is a kit/co-packaged product with the form code, C47916 (for Kit), 

the document type/product type is Bulk Ingredient (53409-9), Human OTC Drug 

Label (34390-5) or Human Prescription Drug Label (34391-3), the marketing 

start date for the co-packaged product is on or after November 1st, 2020 and the 

marketing category is not Cosmetic (C86965), Dietary Supplement (C86952), 

Exempt Device (C80438), Humanitarian Device Exemption (C80440), Medical 

Food (C86964), Premarket Application (C80441) or Premarket Notification

(C80442), then each inner component product (<partProduct>) with a drug 

marketing category (see Table 1) has a unique NDC product code. 

3.1.7 Marketing Category and Application Number 

The approval structure specifies in the <code> the marketing category under which 

the product is approved for marketing. Products marketed under an approved 

application have an application number in the <id extension> and application tracking 

system under <id root>. Products marketed under a monograph provide the 

monograph ID for the monograph <id extension> and the OTC Monograph ID under 

<id root>. If there is no application number or monograph ID, the id element is 

omitted.
SPL Implementation Guide with Validation Procedures v1

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<subjectOf> 

 <approval> 

 <id extension="application, monograph ID, or monograph number" 

 root="FDA document tracking system OID, OTC Monograph ID OID, or 

CFR OID"/> 

 <code code="code for marketing category" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name"/> 

 <effectiveTime> 

 <low value=“approval date”/> 

 </effectiveTime> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

 </territory> 

 </territorialAuthority> 

 </author> 

 </approval> 

</subjectOf> 

Marketing category is connected through the <subjectOf> element which may appear 

on the main product: 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct/> 

 <subjectOf/> 

or on parts: 

<part> 

 <partProduct/> 

 <subjectOf/> 

Example:

<subjectOf> 

 <approval> 

 <id extension="NDA123456" root="2.16.840.1.113883.3.150"/> 

 <code code="C73594" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="NDA"/> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

Validation Procedures 

3.1.7.1 There is one marketing category for every product and product part, except if the 

document type is Cosmetic Product Listing (103572-4), Cosmetic Facility 

Registration (103573-2), Cosmetic Facility Registration – Amendment (X8888-

1), Cosmetic Facility Registration - Biennial Renewal (X8888-4), Cosmetic – 

Update (X8888-5), Indexing – Product Concept (73815-3), Indexing - Warning 
3 Product Data Elements

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Letter Alert (77288-9), or Out of Business Notification (53411-5), FDA-Initiated 

Compliance Action Drug Registration and Drug Listing Inactivation (89600-

1),or FDA-Initiated Compliance Action Drug Registration and Drug Listing 

Inactivation – Animal Drug (99282-6), or there is no marketing status other 

than new or cancelled.

3.1.7.2 There is a marketing category code.

3.1.7.3 Code comes from the Marketing category list.

3.1.7.4 Display name matches the code

3.1.7.5 Code system is 2.16.840.1.113883.3.26.1.1

3.1.7.6 Territorial authority is as above

Marketing Category vs. Application Number

The following are validation procedures relating marketing category to application 

numbers:

3.1.7.7 If the code is C73583 (ANADA), C73584 (ANDA), C73585 (BLA), C73588 

(conditional NADA), C73593 (NADA), C73594 (NDA), C73605 (NDA 

authorized generic), C75302 (IND), C80438 (Exempt device), C80440 

(Humanitarian Device Exemption), C80441 (Premarket Application), C80442 

(Premarket Notification), C92556 (Legally Marketed Unapproved New Animal 

Drugs for Minor Species), C175238 (Multi-Market Approved Product) or 

C175462 (SIP Approved Drug), then the id root is 2.16.840.1.113883.3.150 

(FDA application tracking system).

3.1.7.8 [RESERVED]

3.1.7.9 If the code is C73583 (ANADA), then the id extension has the prefix “ANADA” 

followed by 6 digits

3.1.7.10 If the code is C73584 (ANDA), then the id extension has the prefix “ANDA” or 

“BA” followed by 6 digits

3.1.7.11 If the code is C73585 (BLA), then the id extension has the prefix “BLA” 

followed by 6 digits

3.1.7.12 If the code is C73593 (NADA) or C73588 (Conditional NADA), then the id 

extension has the prefix “NADA” followed by 6 digits

3.1.7.13 If the code is C73594 (NDA), or C73605 (NDA authorized generic), then the id 

extension has the prefix “NDA” or “BN” followed by 6 digits
SPL Implementation Guide with Validation Procedures v1

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3.1.7.14 If the code is C75302 (IND), then the id extension has the prefix “IND” 

followed by 6 digits

3.1.7.15 [RESERVED].

3.1.7.16 [RESERVED].

3.1.7.17 [RESERVED].

3.1.7.18 If the code is C92556 (Legally Marketed Unapproved New Animal Drugs for 

Minor Species), then the id extension has the prefix “MIF” followed by 6 digits.

3.1.7.19 If the code is C80438 (Exempt device), then the id extension consists of 3 letters

3.1.7.20 If the code is C80440 (Humanitarian Device Exemption), then the id extension 

has a prefix “H” followed by 6 digits

3.1.7.21 If the code is C80441 (Premarket Application), then the id extension has a prefix 

“P” or “BP” followed by 6 digits

3.1.7.22 If the code is C80442 (Premarket Notification), then the id extension has a

prefix “K” or “BK” followed by 6 digits.

3.1.7.23 If the code is not C73583 (ANADA), C73584 (ANDA), C73585 (BLA), C73588 

(Conditional NADA), C73593 (NADA), C73594 (NDA), C200263 (OTC 

Monograph Drug), C73605 (NDA authorized generic), C75302 (IND), C80438 

(Exempt device), C80440 (Humanitarian Device Exemption), C80441 

(Premarket Application), C80442 (Premarket Notification), C132333 (Approved 

drug product manufactured Under Contract), C73626 (bulk ingredient), C96793 

(bulk ingredient for human prescription compounding), or C98252 (bulk 

ingredient for animal drug compounding), C94795 (Drug for further 

processing), C92556 (Legally Marketed Unapproved New Animal Drugs for 

Minor Species), C175238 (Multi-Market Approved Product) or C175462 (SIP 

Approved Drug), then there is no id (application number or regulatory citation 

or monograph ID).

3.1.7.24 If the marketing category is Approved drug product manufactured Under 

Contract (C132333), then there is an id (application number or regulatory 

citation).

3.1.7.25 If the marketing category is Approved drug product manufactured Under 

Contract (C132333), then the id extension has the prefix “NDA”, “ANDA”, or 

“BLA” followed by 6 digits

3.1.7.26 If the marketing category is Bulk Ingredient (C73626), Bulk Ingredient for 

Human Prescription Compounding (C96793), or Bulk Ingredient for Animal 
3 Product Data Elements

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Drug Compounding (C98252), or Drug for Further Processing (C94795) and 

there is an id, then the id extension has the prefix “DMF” or “VMF” followed by 

6 digits.

3.1.7.27 If the marketing category is C175238 (Multi-Market Approved Product) or 

C175462 (SIP Approved Drug), then the id extension has the prefix NDA, BN, 

or BLA followed by 6 digits.

3.1.7.28 If the marketing category is C200263 (OTC Monograph Drug), then the id root 

is 2.16.840.1.113883.3.9421 (OTC Monograph ID)

Application Number Consistency

3.1.7.29 If the marketing category is ANDA (C73584), BLA (C73585), or NDA (C73594) 

and the SPL document type is not Lot Distribution Data (66105-8) or Vaccine

Label (53404-0) and the application number was already submitted, then the 

active ingredient UNIIs are the same as in any previous submission of a product 

with the same application number.

3.1.7.30 If the application number is referenced in any Product Concept Indexing file, 

then the active ingredient, strength and active moiety match a Product Concept 

Indexing file, except if the document type is Lot Distribution Data (66105-8) or 

the Indexing – Product Concept (73815-3) file itself.

3.1.7.31 If the application number or citation is referenced in the OTC drug product 

application list, then the active ingredient (UNII) and route of administration 

associated with the application number matches the entry in the list.

3.1.7.32 If on or after March 23th 2020, the application number is present in the NDA to 

BLA Conversion List, then the marketing category and application number 

prefix must be changed to BLA.

Application Approval Date

3.1.7.33 There may be an approval date (effective time).

3.1.7.34 Approval date (effectiveTime) has a low boundary.

3.1.7.35 Approval date has no high boundary.

3.1.7.36 Approval date has at least the precision of day (YYYYMMDD).

3.1.7.37 If the marketing category code is not C73584 (ANDA), C73585 (BLA), C73594 

(NDA), or C175462 (SIP approved drug), then there is no approval date.

3.1.7.38 [RESERVED].
SPL Implementation Guide with Validation Procedures v1

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3.1.8 Marketing status 

The marketing status provides information on when the product is on or off the 

market. 

<subject> 

 <manufacturedProduct>...</manufacturedProduct> 

 <subjectOf> 

 <marketingAct> 

 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <statusCode code="active"/> 

 <effectiveTime> 

 <low value="20040120"/> 

The <code> indicates the activity of “marketing” (or in cases of some packages as 

“marketing of sample packages not for sale”). The status of the product is described 

in the <statusCode> as either “active” for being on the market or “completed” when a 

product is discontinued, or “new” to indicate that the product item code is being 

reserved for future use. If the status of the product is cancelled, the NDC reservation 

is being cancelled. The date when the product is on or marketed or discontinued is 

included in the <effectiveTime>. The date when the product is on the market is 

characterized by the <low value>.

Example of a currently marketed product:

<subjectOf> 

 <marketingAct> 

 <code code="C53292" codeSystem="2.16.840.1.112883.3.26.1.1"/> 

 <statusCode code="active"/> 

 <effectiveTime> 

 <low value="date when on the market"/> 

 </effectiveTime> 

 </marketingAct> 

</subjectOf> 

The marketing discontinuation date such as the expiration date of the last lot released 

to the market is characterized by the <high value>. 

Example of a product that is discontinued: 

<subjectOf> 

 <marketingAct> 

 <code code=”C53292” codeSystem=”2.16.840.1.112883.3.26.1.1”/> 

 <statusCode code="completed"/> 

 <effectiveTime> 

 <low value="date when the product is on the market"/> 

 <high value="date when the product is going to be off the market"/> 

 </effectiveTime> 

 </marketingAct> 

</subjectOf> 

For some types of products, a marketing status may be provided on the package level: 
3 Product Data Elements

60 

<asContent> 

 <containerPackagedProduct>...</containerPackagedProduct> 

 <subjectOf> 

 <marketingAct> 

 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <statusCode code="active"/> 

 <effectiveTime> 

 <low value="20040120"/> 

Packages may also be marked as being a drug sample rather than regularly marketed 

for sale, Packages that are samples are marked with a marketingAct with the code

C96974 instead of the default marketing act code C53292: 

<asContent> 

 <containerPackagedProduct>...</containerPackagedProduct> 

 <subjectOf> 

 <marketingAct> 

 <code code="C96974" codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <statusCode code="active"/> 

 <effectiveTime> 

 <low value="20040120"/> 

The package marketing status and start and end date (if applicable) are in the same 

marketing act.

NDC Code Reservations

For human and animal drug products, NDC code reservations may be sent. This is 

done in a listing file, except that content of labeling is not included. The products that 

appear in the listing file, do not need a marketing category. Therefore it is not 

determined if they are drugs, dietary supplements, cosmetics, devices or biologic 

products. 

All products require 

• a non-proprietary name and 

• a dose form. 

Note that a proprietary name is not required. Packaging is also not required. 

There are 3 types of products with further data requirements.

• drugs need at least one full active ingredient specification, with ingredient 

name, UNII, strength, active moiety, and basis of strength. 

• dietary supplements need an ingredient (classCode INGR) with ingredient 

name and UNII.

A marketing status is required for every product, and the status 'new' indicates that 

this product is provided to reserve an NDC product code. 
SPL Implementation Guide with Validation Procedures v1

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If the marketing status is 'new' a marketing start date should be provided up to 2 years 

in the future.

An NDC reservation should be sent as one document those products which will likely 

be contained in the same listing file once these products begin to be marketed. The 

document set id will then be used by the listing file, i.e., the next version of an NDC 

reservation will be a listing file. In a listing file which follows an NDC reservation, 

every NDC code that has been reserved needs to be disposed of as either active or 

cancelled. The active products become the actively listed products (their marketing 

start dates may still be in the future), and the NDC codes that are released will be 

marked as cancelled. Once cancelled, these NDC codes do not need to be mentioned 

any more in subsequent listing files.

Note that currently it is not expected that NDC reservations will be updated before the 

submission of the first listing files.

Validation Procedures

3.1.8.1 There is one marketing status for each top-level product (part products do not 

need this), except if the document type is a Animal Compounded Drug Label

(77647-6), Human Compounded Drug Label (75031-5), Cosmetic Product 

Listing (103572-4), Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration – Amendment (X8888-1), Cosmetic Facility Registration -

Biennial Renewal (X8888-4), Cosmetic – Update (X8888-5), Cosmetic –

Abbreviated Renewal (X8888-6), Indexing - Product Concept (73815-3), Lot 

Distribution Data (66105-8), Indexing - Warning Letter Alert (77288-9), 

Indexing - Biologic or Drug Substance (77648-4), Risk Evaluation & Mitigation 

Strategies related (82353-4, 85273-1, 85274-9, 82351-8), Out of Business 

Notification (53411-5), FDA-Initiated Compliance Action Drug Registration 

and Drug Listing Inactivation (89600-1), or FDA-Initiated Compliance Action 

Drug Registration and Drug Listing Inactivation – Animal Drug (99282-6), or 

if the SPL file is for Salvaged Drugs (having business operation as salvage, 

C70827).

3.1.8.2 There is not more than one marketing status on any one item.

3.1.8.3 Marketing act code is C53292 (or C96974 for packages marked as Drug 

Sample) and code system is 2.16.840.1.113883.3.26.1.1.

3.1.8.4 Marketing status code is active, or completed, or new, or cancelled.

3.1.8.5 If the status code is active or new, then there is a low value (marketing start 

date) and no high value (marketing end date)

3.1.8.6 If the marketing status code is completed, (discontinued) then there is a low and 

high value, except if the document type is Cosmetic Product Listing (103572-4)

or Cosmetic – Update (X8888-5).
3 Product Data Elements

62 

3.1.8.7 The effective time low (marketing start date) and high boundary (marketing end 

date) have at least the precision of day in the format YYYYMMDD

3.1.8.8 If there is a high value (marketing end date), then it is not less than the low value 

(marketing start date).

3.1.8.9 A marketing status can not be on an inner package, except if the status code is 

new. 

3.1.8.10 A marketing status can not be on a package for a part of a kit, except if the status 

code is new. 

3.1.8.11 If the marketing start or end date is on a package, then the start date is not before 

the marketing start date of the product and the end date not after the end date of 

the product. 

3.1.8.12 If any of the products in the document has the application number prefix BA or 

BN, then there is no package marketing status. 

3.1.8.13 A marketing status can only be on a package in documents of types Human 

Prescription Drug Label (34391-3), Human OTC Drug Label (34390-5), Drug 

for Further Processing (78744-0), or Bulk Ingredient (53409-9),. 

3.1.8.14 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) then there is no marketing status. 

3.1.8.15 A marketing act with code Drug Sample (C96974) is on a package only. 

3.1.8.16 If the package is marked as a drug sample, then there is a package item code.

3.1.8.17 If an item has a marketing status active, then at least one of its packages has 

either no explicit marketing status at all, or a marketing status of active, except if 

the document type is Risk Evaluation & Mitigation Strategies (82351-8), 

Cosmetic Product Listing (103572-4), Cosmetic Facility Registration (103573-

2), Cosmetic Facility Registration – Amendment (X8888-1), Cosmetic Facility 

Registration - Biennial Renewal (X8888-4), or Cosmetic – Update (X8888-5). 

3.1.8.18 If the marketing status code is active or completed, then previous marketing 

status code for the item code (NDC product code) is not cancelled. 

3.1.8.19 If the marketing status code is completed, then previous marketing status code 

for the item code (NDC product code) is not new. 

3.1.8.20 If the product is regulated by CDER, then the marketing start or end date are 

present at the outermost package level, except for Human Compounded Drug 

Label (75031-5) or if marketing status is new or cancelled. 
SPL Implementation Guide with Validation Procedures v1

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Validation Procedures for NDC Reservations

3.1.8.21 Marketing Status code new or cancelled can not be used at package level.

3.1.8.22 If the marketing status code is new or cancelled, then there is a start marketing 

date.

3.1.8.23 If the marketing status code is new, then marketing start date is two years or less 

from the date of the submission of the NDC reservation request.

3.1.8.24 If the marketing status code is new or cancelled, then marketing start date is the 

same for all products.

3.1.8.25 If the marketing status is cancelled, then there is no marketing end date.

3.1.8.26 If the marketing status code is cancelled, then previous marketing status code 

for the item code (NDC product code) is new.

3.1.8.27 If the marketing status code is new or cancelled, then marketing start date cannot 

be changed from the previous version.

3.1.8.28 If the marketing status code is new or cancelled, then there is an item code 

(NDC product code.)

3.1.8.29 If the marketing status is new, then the product item code has not been 

previously submitted in a document of a different set id, except if in that other 

document its marketing status is cancelled.

3.1.8.30 If the marketing status code is new or cancelled, then there is a non-proprietary 

name (generic medicine name.)

3.1.8.31 If the marketing status code is new or cancelled, then there is an active 

ingredient.

3.1.8.32 If any of the products have the marketing status of new, then products having

any active ingredients have the same set of active ingredient substances.

3.1.8.33 Additional validation procedures for NDC product codes apply, see: 3.2.1.2 – 5

and 3.2.1.10 – 15.

3.1.8.34 NDCs can be reserved for drugs in development for a period of up to two years 

from the date of receipt of the initial reservation. Once the product(s) included 

on an NDC Reservation SPL are ready to launch in the U.S. market, the NDC 

Reservation SPL for the product(s) should be revised (change Marketing Status 

for ALL products on the SPL to “active”) and converted into a full product 

listing SPL.
3 Product Data Elements

64 

3.1.8.35 For NDC reservation questions for CDER products, contact 

eDRLS@fda.hhs.gov. 

3.1.8.36 For NDC reservation questions for CVM products, contact 

Charise.Kasser@fda.hhs.gov. 

3.1.8.37 If a document contains any item code reservation (marketing status codes is 

new), then the SPL document type is Bulk Ingredient (53409-9), Cellular 

Therapy (60684-8), Drug for Further Processing (78744-0), Human OTC Drug 

Label (34390-5), Human Prescription Drug Label (34391-3), License Blood 

Intermediates/Paste Label (53407-3), Licensed Minimally Manipulated Cells 

Label (53408-1), Licensed Vaccine Bulk Intermediate Label (53406-5), NonStandardized Allergenic Label (53405-7), Plasma Derivative (60683-0), 

Standardized Allergenic (60682-2), or Vaccine Label (53404-0) or CVM

products. 

3.1.8.38 If a document contains any item code reservation (marketing status codes is new

or cancelled), then there are no marketing status codes of active or completed, 

except a part of a kit may be active if the kit is new or cancelled. 

3.1.8.39 [POSTPONED] If the product information has previously been submitted, and 

the marketing start date is not in the future, then the marketing start date is not 

later than the previously submitted marketing start date.

3.1.8.40 [POSTPONED] The product marketing start date is not after any of the start 

dates of any active or completed marketing status for any of its previously 

submitted packages.

3.1.9 Characteristics 

Many characteristics may be specified for products as specified later for specific 

product types. In general, the characteristic structure allows specifying any properties 

of the product in a code-value pair, the code saying which property is being specified, 

the value saying what the property is for the given product. The characteristics 

structure connects to the product Role through the subjectOf element. 

<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

 </manufacturedProduct> 

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="characteristic value type" ...> 

Some characteristics may be specified for packaged products: 
SPL Implementation Guide with Validation Procedures v1

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<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

 <asContent> 

 <containerPackagedProduct> 

 ... 

 </containerPackagedProduct> 

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="characteristic value type" ...> 

Characteristics listed in Table 6 use one of a number of different data types. Each data 

type uses slightly different XML elements and attributes as shown in the templates 

below: 

Characteristic of type physical quantity (PQ):

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="PQ" value="quantity value" unit="quantity unit"> 

Characteristic of type number (REAL):

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="REAL" value="quantity value"/> 

Characteristic of type integer number (INT):

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="INT" value="quantity value"/> 

Characteristic of coded type (CV):

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="CV" code="value code" 

 codeSystem="value code system OID" 

 displayName="value code display name"> 

Characteristic of type character string (ST):
3 Product Data Elements

66 

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="ST">value string</value> 

Characteristic of type interval of physical quantity (IVL<PQ>):

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="IVL_PQ"> 

 <low value="quantity value low boundary" unit="quantity unit"/> 

 <high value="quantity value high boundary" unit="quantity unit"/> 

 </value> 

Characteristic of type Boolean (true/false value)

 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="BL" value="true or false"/> 

Table 4: Characteristic codes and code systems.

Name Code System OID / Code Data 

Type

Description

SPL 

Characteristics

2.16.840.1.113883.1.11.19255 Used early on with Existing SPL for drugs 

characteristics codes that are possibly 

applicable for devices:

SPLSIZE PQ Greatest dimension in millimeter

SPLCOLOR CV color code from NCI Thesaurus

SPLIMAGE ED Photographic image of the product for the 

purpose of identification, taken under 

standardized conditions.

LOINC 2.16.840.1.113883.6.1 Used for metrologically well defined 

properties.

NCI Thesaurus 2.16.840.1.113883.3.26.1.1 Used rarely (if at all) for characteristic 

codes.

Validation Procedures 

3.1.9.1 There is a characteristic property code with code and code system

3.1.9.2 Characteristic property code system is 2.16.840.1.113883.1.11.19255, 

2.16.840.1.113883.6.1, or 2.16.840.1.113883.3.26.1.1. 

3.1.9.3 There is a characteristic value with specified type appropriate for the 

characteristic property.
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3.1.9.4 Value type is PQ, INT, IVL_PQ, CV, CE, ST, ED, or BL 

3.1.10 Combination Product Type 

Combination products are defined in 21 CFR 3.2(e).

To mark products as combination products, the nearest combining package should 

bear the combination product type characteristic:

<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

 <asContent> 

 ... 

 <subjectOf> 

 <characteristic> 

 <code code="SPLCMBPRDTP" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="C102835" 

 codeSystem="2.16.840.1.113883.3.26.1.1" xsi:type="CV" 

 displayName="Type 2: Prefilled Drug Delivery Device/System"> 

Validation Procedures 

3.1.10.1 Code and code system are as above 

3.1.10.2 Value code system is 2.16.840.1.113883.3.26.1.1 

3.1.10.3 Value comes from the Combination Product Type list. 

3.1.10.4 Display name matches the value code

3.1.10.5 If the document type is for Bulk Ingredient (53409-9), Bulk Ingredient – Animal 

Drug (81203-2), OTC Animal Drug Label (50577-6), OTC Type A Medicated 

Article Animal Drug Label (50576-8), OTC Type B Medicated Feed Animal 

Drug Label (50574-3), OTC Type C Medicated Feed Animal Drug Label

(50573-5), Prescription Animal Drug Label (50578-4), VFD Type A Medicated 

Article Animal Drug Label (50575-0), VFD Type B Medicated Feed Animal 

Drug Label (50572-7), VFD Type C Medicated Feed Animal Drug Label

(50571-9), Cosmetic (58474-8), Dietary Supplement (58476-3), Medical Food

(58475-5), Human Compounded Drug Label (75031-5), Licensed Vaccine Bulk 

Intermediate Label (53406-5), Drug for Further Processing (78744-0), Animal 

Compounded Drug Label (77647-6), or Animal Cells, Tissues, and Cell and 

Tissue Based Product Label (98075-5), then there is no combination product 

type characteristic on any package.

3.1.10.6 If the dosage form (form code) is Aerosol, Metered (C42960), Gel, Metered

(C60930), Powder, Metered (C42961), Spray, Metered (C42962) or Tablet with 
3 Product Data Elements

68 

Sensor (C147579), then there is a combination product type other than Type 0: 

Not a Combination Product (C112160). 

3.1.10.7 If the dosage form (form code) is Aerosol, Metered (C42960), Gel, Metered

(C60930), Powder, Metered (C42961), or Spray, Metered (C42962), then the 

combination product type is Type 2: Prefilled Drug Delivery Device/System 

(syringe, patch, etc.) (C102835) or Type 3: Prefilled Biologic Delivery 

Device/System (syringe, patch, etc.) (C102836). 

3.1.10.8 If the dosage form (form code) is Tablet with Sensor (C147579), then the 

combination product type is Type 4: Device Coated/Impregnated/Otherwise 

Combined with Drug (C102837). 

3.1.10.9 If the package type is Inhaler (C16738), Syringe (C43202), Syringe, Glass 

(C43203), or Syringe, Plastic (C43204), then there is a combination product 

type other than Type 0: Not a Combination Product (C112160). 

3.1.10.10 If the package type is Inhaler (C16738), then the combination product type is 

Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) (C102835) 

or Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

(C102836). 

3.1.10.11 If the package type is Syringe (C43202), Syringe, Glass (C43203), or Syringe, 

Plastic (C43204), then the combination product type is Type 1: Convenience Kit 

of Co-Package (C102834), Type 2: Prefilled Drug Delivery Device/System 

(syringe, patch, etc.) (C102835), Type 3: Prefilled Biologic Delivery 

Device/System (syringe, patch, etc.) (C102836) or Type 9: Other Type of Part 3 

Combination Product (e.g., Drug/Device/Biological Product) (C102842). 

3.1.11 Production Amount

The production amount for a package is specified as: 

<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

 <asContent> 

 ... 

 <subjectOf> 

 <characteristic> 

 <code code="SPLPRODUCTIONAMOUNT" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="INT" value="10000"/> 

Unlimited production amounts are specified as: 

 <value xsi:type="INT" nullFlavor="PINF"/> 
SPL Implementation Guide with Validation Procedures v1

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Validation Procedures 

3.1.11.1 Code and code system are as above 

3.1.11.2 The value is an integer number or null flavor “PINF” to indicate unlimited. 

3.2 Drug, Biologics, Dietary Supplement and Medical Food Products

The drug, dietary supplement and medical food product data elements includes the 

product codes, proprietary and non proprietary name, dosage form, ingredient and 

active moiety name, ingredient identifier, ingredient strength, package quantity, type 

and code, marketing category, marketing status, dosage form appearance, DEA 

schedule, and route of administration. 

Drug products are those products with the appropriate marketing categories listed in 

Table 1: Marketing Category and Product Type. Dietary supplement are those 

products that are associated with the dietary supplement (C86952) marketing 

category. Medical foods are associated with the medical food marketing category

(C86964). 

The drug product consists of a product item code (NDC for drugs and NHRIC for 

dietary supplements or medical foods), proprietary and non proprietary name, and 

dosage form. These are children of <manufacturedProduct>. The proprietary name is 

the name as it appears on the label divided between <name> and <suffix>. The 

<name> is the initial portion of the proprietary name describing the ingredients 

without any other descriptors including trademarks and dosage forms. If necessary, 

<suffix> is used for descriptors such as “extended release”. When using the <suffix>, 

a space after the proprietary name is added as necessary. If there is no proprietary 

name, the non proprietary name is used without any descriptors. The dosage form is 

described in <formCode>. The <genericMedicine><name> is the non proprietary 

name of the product. 

3.2.1 Code and Name 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="0001-0001" codeSystem="2.16.840.1.113883.6.69"/> 

 <name>Tazmin <suffix>XR</suffix></name> 

 <formCode code="C42998" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="tablet"/> 

 <asEntityWithGeneric> 

 <genericMedicine> 

 <name>tazminate hydrochloride</name> 

 </genericMedicine> 

Phonetic spellings of the product and generic names may also be specified: 
3 Product Data Elements

70 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 ... 

 <name>Tazmin <suffix>XR</suffix></name> 

 <name use="PHON">Tas-meen</name> 

 ... 

 <asEntityWithGeneric> 

 <genericMedicine> 

 <name>tazminate hydrochloride</name> 

 <name use="PHON">tas-meen-at hy-droh-clor-aide</name> 

 </genericMedicine> 

Validation Procedures 

3.2.1.1 If the product item code is an NDC/NHRIC (i.e., if the root is 

“2.16.840.1.113883.6.69”), then the following procedures apply: 

3.2.1.2 Code (NDC/NHRIC product code) has two segments separated by a hyphen

3.2.1.3 The first segment (NDC/NHRIC labeler code) is numeric.

3.2.1.4 Segments (NDC/NHRIC product codes) follow the pattern of 4-4, 5-4 or 5-3 

3.2.1.5 The second segment (middle segment of three-segment NDC) is numeric (no 

letters allowed).

3.2.1.6 If the product item code is an ISBT 128 code (i.e., if the root is 

“2.16.840.1.113883.6.18”), then the following procedures apply: 

3.2.1.7 Code contains two segments separated by a hyphen. 

3.2.1.8 The first segment contains the ISBT 128 Facility Identification Number (FIN) 

beginning with a capital letter A-N, P-Z (i.e., all 26 letters except O) followed 

by two alphanumerics A-N, P-Z, 0-9, and two digits. 

3.2.1.9 The second segment contains the ISBT 128 product code beginning with a 

capital letter (A-Z) followed by 4 digits (0-9) and optionally followed by three 

alphanumeric characters.

3.2.1.10 First segment (NDC/NHRIC labeler code) matches a labeler code associated 

with the Labeler id (labeler’s DUNS Number) in a previously submitted 

NDC/NHRIC Labeler Code or NDC Labeler Code – Animal Drug SPL 

document, except for parts. 

3.2.1.11 Code (NDC product code) has the same labeler segment as the NDC 

product/item code of all top-level products in this document, except under parts. 
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3.2.1.12 Code (NDC product code) has the same length as all other NDC product/item 

codes with the same labeler segment in this document (i.e., all NDC 

product/item codes from one labeler have the same consistent length and hence 

all package item codes have the same consistent configuration.)

3.2.1.13 Code (NDC product code) has the same length as any other NDC product/item 

codes of the same labeler (i.e., all NDC product/item codes by the same labeler 

have the same consistent length and hence all package item codes have the same 

consistent configuration.)

3.2.1.14 There is only one product data elements section for each NDC product/item 

code, i.e., the same product is not described more than once except under parts.

3.2.1.15 If the NDC product/item code is mentioned elsewhere in the document, then the 

product and generic name (along with their phonetic names, if any are 

specified), dosage form, UNII and strength of all ingredients are the same.

3.2.1.16 There is a product name, except if the document type is Indexing - Product 

Concept (73815-3) or there is no marketing status other than new or cancelled.

3.2.1.17 Product name contains no special symbols (e.g., no “®” or “TM” etc) and no 

“USP” or dosage forms.

3.2.1.18 There may be one phonetic name after the product name.

3.2.1.19 Phonetic name conforms to the phonetic name specification.

3.2.1.20 There is a form code (dosage form), except if the document type is Indexing -

Product Concept (73815-3) or Lot Distribution Data (66105-8), Indexing -

Biologic or Drug Substance (77648-4) or Risk Evaluation & Mitigation 

Strategies (82351-8) or Indexing – Risk Evaluation & Mitigation Strategies

(82353-4).

3.2.1.21 Form code (dosage form) has the code system 2.16.840.1.113883.3.26.1.1

3.2.1.22 If the product has parts, then the form code is C47916 (for KIT)

3.2.1.23 Display name matches the code

3.2.1.24 There is a non-proprietary (generic medicine) name, except if the document type 

is Indexing - Product Concept (73815-3) or Lot Distribution Data (66105-8) or 

Indexing - Biologic or Drug Substance (77648-4) or Indexing – Risk Evaluation 

& Mitigation Strategies (82353-4).

3.2.1.25 Non-proprietary (generic medicine) name contains no special symbols (e.g., no 

“®” or “TM” etc) and no “USP” or dosage forms.
3 Product Data Elements

72

3.2.1.26 Non-proprietary (generic medicine) name contains no suffix.

3.2.1.27 Non-proprietary (generic medicine) name contains no more than 512 characters.

3.2.1.28 There may be one phonetic name after the non proprietary name.

3.2.1.29 Phonetic name conforms to the phonetic name specification.

3.2.1.30 If the NDC product/item code was previously submitted, then the product name 

is same as in the most recent submission for this NDC product/item code.

3.2.1.31 If the NDC product/item code was previously submitted, then the nonproprietary (generic) name is the same as in the most recent submission for this 

NDC product/item code, except if there is no marketing status other than new or 

cancelled.

3.2.1.32 If the NDC product/item code was previously submitted, then the active 

ingredient UNIIs and active ingredient strengths are the same as in the most 

recent submission for this NDC product/item, except if there is no marketing 

status other than new or cancelled.

3.2.1.33 If the NDC product/item code was previously submitted, then the product 

dosage form is same as in the most recent submission for this NDC product/item 

code.

3.2.1.34 If the NDC product/item code was previously submitted, then the product 

characteristic of size is the same as in the most recent submission for this NDC 

product/item code.

3.2.1.35 If the NDC product/item code was previously submitted, then the product 

characteristic of shape is the same as in the most recent submission for this NDC 

product/item code.

3.2.1.36 If the NDC product/item code was previously submitted, then the product 

characteristic of color are same as in the most recent submission for this NDC 

product/item code.

3.2.1.37 If the NDC product/item code was previously submitted, then the product 

characteristic of imprint code is the same as in the most recent submission for 

this NDC product/item code.

3.2.1.38 [RESERVED]

3.2.1.39 If the NDC product/item code was previously submitted, then the application 

number is the same as in the most recent submission for this NDC product/item 
SPL Implementation Guide with Validation Procedures v1

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code except if after March 23rd, 2020 the application number is present in the 

NDA to BLA conversion list and changed to the BLA prefix. 

3.2.1.40 The dosage form code cannot be “not applicable” (C48624), for document types 

other than Recombinant Deoxyribonucleic Acid Construct Label (78745-7), or 

Intentional Animal Genomic Alteration Label (101437-2). 

3.2.1.41 If the NDC product/item code was previously submitted, then the product 

characteristic of flavor is the same as in the most recent submission for this 

NDC product/item code. 

3.2.1.42 If the NDC product/item code was previously submitted, then the product 

characteristic of scoring is the same as in the most recent submission for this 

NDC product/item code. 

3.2.1.43 If the NDC product/item code was previously submitted, then the product 

phonetic name (if specified) is the same as in the most recent submission for this 

NDC product/item code. 

3.2.1.44 If the NDC product/item code was previously submitted, then the nonproprietary (generic) phonetic name (if specified) is the same as in the most 

recent submission for this NDC product/item code, except if there is no 

marketing status other than new or cancelled.

3.2.1.45 If the document type is human OTC drug label (34390-5), then there may be a 

cosmetic product category (asSpecializedKind element) with a code (see Section 

3.4.3.2 and following). 

3.2.1.46 If the document type is not human OTC drug label (34390-5), then there is no 

cosmetic product category (asSpecializedKind element). 

3.2.2 Product source 

<asEquivalentEntity classCode=“EQUIV”> 

 <code code=“C64637” codeSystem=“2.16.840.1.113883.3.26.1.1”/> 

 <definingMaterialKind> 

 <code code=“source product item code” 

 codeSystem=“2.16.840.1.113883.6.69”/> 

Validation Procedures 

3.2.2.1 As equivalent entity class code, code and code system are as above

3.2.2.2 If there is a classCode, it is “EQUIV”.

3.2.2.3 If the NDC product source (equivalent product) is present, then the active 

ingredients UNII and active ingredients strengths are the same as that of product 

source.
3 Product Data Elements

74 

3.2.2.4 If the NDC product source (equivalent product) is present, then the product 

characteristic of size is the same as that of the product source.

3.2.2.5 If the NDC product source (equivalent product) is present, then the product 

characteristic of shape is the same as that of the product source.

3.2.2.6 If the NDC product source (equivalent product) is present, then the product 

characteristics of color are the same as that of the product source.

3.2.2.7 If the NDC product source (equivalent product) is present, then the product 

characteristic of imprint code is the same as that of the product source.

3.2.2.8 If the NDC product source (equivalent product) is present, then the product 

characteristic of flavor is the same as that of the product source.

3.2.2.9 If the NDC product source (equivalent product) is present, then the product 

characteristic of scoring is the same as that of the product source.

3.2.2.10 If the NDC product source (equivalent product) is present, then the product 

dosage form is the same as that of the product source. 

3.2.2.11 If one of the listed establishment operations is Repack (C73606) or Relabel 

(C73607), then there is a product source reference. 

3.2.3 Active ingredient 

Active ingredients are specified as follows:

<ingredient classCode="ACTIM, ACTIB, or ACTIR"> 

 <quantity> 

 <numerator value="10" unit="mg"/> 

 <denominator value="1" unit="1"/> 

 </quantity> 

 <ingredientSubstance> 

 <code code="1234567890" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>tazminate malate</name> 

The class code for active ingredient is dependent on the basis of the strength. If the 

basis of strength is the active ingredient, the class code is “ACTIB”. If the basis of 

strength is the active moiety, the class code is “ACTIM”. If the basis of strength is a 

reference drug, the class code is “ACTIR”. The strength is represented as a numerator 

and denominator. The UCUM code is used for the unit of measure. The UCUM code 

for a unit that is an “each” is “1” Examples of “each” is in the table below.

In most cases, the strength used is that for a single dose following the conventions in 

Table 5. In the table, an example of “mass” is milligrams, an example of “volume” is 

milliliter, an example of “time” is hour, and an example of “each” is tablet.
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Table 5: Conventions for expressing strength

Product Numerator unit Denominator 

unit

Oral solid Mass Each

Oral liquid Mass Volume

Oral powder for reconstitution with a known volume Mass Volume

Oral powder for reconstitution with a variable volume Mass Each

Suppository Mass Each

Injection liquid Mass Volume

Injection powder for reconstitution with a known volume Mass Volume

Injection powder for reconstitution with a variable volume Mass Each

Inhaler powder Mass Each

Inhaler liquid Volume Each

Inhaler blister Mass Each

Topical cream or ointment Mass Mass

Topical gel or lotion Mass Volume

Transdermal patch Mass Time

Bulk liquid Mass Volume

Bulk solid Mass Mass

Validation Procedures

3.2.3.1 Class code for active ingredients are ACTIB, ACTIM or ACTIR

3.2.3.2 If the document type is Bulk ingredient (53409-9) or Bulk ingredient – Animal 

drug (81203-2) with a marketing category of Bulk ingredient (C73626), then 

there is one and only one active ingredient.

3.2.3.3 If the product has no parts and is not a part, then there are one or more active 

ingredients except if the document is a Indexing - Product Concept (73815-3) or 

Lot Distribution Data (66105-8), Indexing - Warning Letter Alert (77288-9), 

Risk Evaluation & Mitigation Strategies (82351-8), Indexing - Risk Evaluation 

& Mitigation Strategies (82353-4), or if the SPL file is for Salvaged Drugs, i.e., 

having business operation as salvage (C70827), or there is no marketing status 

other than new or cancelled.

3.2.3.4 If the product has parts, then the active ingredients are under parts

3.2.3.5 There is a strength with a numerator and denominator, except if the document is 

a Indexing - Biologic or Drug Substance (77648-4).

3.2.3.6 If the document type is Bulk ingredient (53409-9) or Bulk ingredient – Animal 

drug (81203-2) with a marketing category of Bulk ingredient (C73626), then 

numerator and denominator (representing strength amount) are the same.

3.2.3.7 The strength numerator is based on mass (e.g., mg or g) and not volume (e.g. 

mL or L), except for ingredients such as water, alcohol, and gases.
3 Product Data Elements

76 

3.2.3.8 There is a unit of measure in the strength amount's numerator and denominator, 

except if the document type is Licensed Minimally Manipulated Cells Label

(53408-1).

3.2.3.9 If the document type is Bulk Ingredient (53409-9), Drug for Further Processing

(78744-0), Human Compounded Drug Label (75031-5), Human OTC Drug 

Label (34390-5) or Human Prescription Drug Label (34391-3), then the 

numerator unit cannot be “1”. 

3.2.3.10 If the document type code is Vaccine Label (53404-0) and if there is any active 

ingredient under the main product or under its first part, then at least one active 

ingredient code is on the list of active ingredients approved for vaccines. 

3.2.4 Active moiety

<ingredient classCode="ACTIR"> 

 <ingredientSubstance> 

<activeMoiety> 

 <activeMoiety> 

 <code code="0987654321" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>tazminic acid</name> 

Validation Procedures 

3.2.4.1 There are one or two active moieties, except if the document type is Indexing - 

Biologic or Drug Substance (77648-4).

3.2.4.2 There is an active moiety code (UNII)

3.2.4.3 Code system is 2.16.840.1.113883.4.9 

3.2.4.4 There is an active moiety name for each active moiety

3.2.4.5 If the active ingredient is in the active-ingredient-active-moiety-validation-list 

(see FDA SPL web page for list https://www.fda.gov/industry/fda-resourcesdata-standards/structured-product-labeling-resources), then the active moiety 

and basis of strength is the corresponding active moiety and basis of strength 

respectively in this list, except if the document type is for Bulk ingredient

(53409-9), Bulk ingredient – Animal drug (81203-2), or Drug for Further 

Processing (78744-0) or there is no marketing status other than new or 

cancelled. 

3.2.4.6 If the active ingredient is not in the active-ingredient-active-moiety-validationlist (see FDA SPL web page for list https://www.fda.gov/industry/fda-resourcesdata-standards/structured-product-labeling-resources), then the active moiety 

name does not include any of the names in the active moiety validation (counter 

ion) list (see FDA SPL web page for list), except if the word appears by itself 

optionally followed by “(ester)”, “cation” or “anion” or “ion”. 
SPL Implementation Guide with Validation Procedures v1

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3.2.4.7 Active moiety name matches the code (UNII)

3.2.5 Reference Ingredient for Strength

<ingredient classCode=“ACTIR”> 

 <ingredientSubstance> 

 <asEquivalentSubstance> 

 <definingSubstance> 

 <code code="A123455678" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>tazemate formate</name> 

Validation Procedures 

3.2.5.1 If the class code is ACTIR, then there is an asEquivalentSubstance element with 

a defining substance, except if there is no marketing status other than new or 

cancelled. 

3.2.5.2 If the class code is not ACTIR, then there is no asEquivalentSubstance element 

3.2.5.3 There is a reference ingredient code

3.2.5.4 Code system is 2.16.840.1.113883.4.9 

3.2.5.5 There is a name (preferred substance name)

3.2.5.6 The name matches the code (UNII)

3.2.6 Inactive ingredient 

The inactive ingredient includes the inactive ingredient class code, ingredient name, 

identifier, and strength. The element <ingredient> is a child of 

<manufacturedProduct>. The class code for inactive ingredient is “IACT”. The 

strength, if needed, is represented as a numerator and denominator and is described 

using UCUM units of measure. If the inactive ingredient is confidential, the 

element<ingredient> includes <confidentialityCode code="B" 

codeSystem="2.16.840.1.113883.5.25"/>. 

<ingredient classCode="IACT"> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

 <quantity> 

 <numerator value="value" unit="UCUM code"/> 

 <denominator value="value" unit="UCUM code"/> 

 </quantity> 

 <ingredientSubstance> 

 <code code="UNII" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>inactive ingredient name</name> 

 </ingredientSubstance> 

</ingredient> 
3 Product Data Elements

78 

Validation Procedures 

3.2.6.1 There are zero to many inactive ingredients.

3.2.6.2 If the document type is human OTC drug label (34390-5), then there is at least 

one inactive ingredient, except if the active ingredient(s) comprise 100% of the 

product or there is no marketing status other than new or cancelled, or the 

inactive ingredient section (51727-6) has the text “none”.

3.2.6.3 Class code is IACT

3.2.6.4 If the product has parts, then the inactive ingredients are under parts 

3.2.6.5 If the document type is human OTC drug label (34390-5), then there is no 

confidentiality code.

3.2.6.6 There is no ingredient other than active ingredient (having class code ACTIM, 

ACTIR, ACTIB), inactive ingredient (having class code IACT), adjuvant 

(having class code ADJV), and those having class code CNTM, except if the 

document is a Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) or there is no marketing status other than 

new or cancelled. 

3.2.7 Packaging 

The format for packaging specification is:

<asContent> 

 <quantity> 

 <numerator value="100" unit="1"/> 

 <denominator value="1"/> 

 </quantity> 

 <containerPackagedProduct> 

 <code code="0001-0001-05" codeSystem="2.16.840.1.113883.6.69"/> 

 <formCode code="C43169" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="bottle"/> 

Validation Procedures 

3.2.7.1 Every top-level product has an “as content” (package information) element 

(optional for parts), except if the document is a Indexing - Product Concept

(73815-3), Lot Distribution Data (66105-8), Indexing - Warning Letter Alert

(77288-9), Indexing - Biologic or Drug Substance (77648-4), Risk Evaluation & 

Mitigation Strategies (82351-8) or Indexing – Risk Evaluation & Mitigation 

Strategies (82353-4), or there is no marketing status other than new or cancelled, 

or if the SPL file is for Salvaged Drugs, i.e., having business operation as 

salvage (C70827). 
SPL Implementation Guide with Validation Procedures v1

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3.2.7.2 If outer package description has a production quantity characteristic, then 

document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6). 

3.2.7.3 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) then each outer package description has a 

production quantity characteristic. 

3.2.7.4 The outer package item code is not associated with another set id except under 

parts; therefore the original set ID included in the previous version of the file 

with the outer package item code should be used. 

3.2.7.5 If the package item code has been previously submitted, then the package form 

code (package type) and quantity value and unit are the same as in the most 

recent submission for this package item code. 

3.2.7.6 There are no drug package characteristics other than the ones mentioned in this 

document. 

3.2.7.7 The package type code cannot be not applicable (C123723), for documents of 

types other than Recombinant Deoxyribonucleic Acid Construct Label (78745-7) 

or Intentional Animal Genomic Alteration Label (101437-2). 

3.2.8 Parts 

Products with one or more parts 

<part> 

 <quantity> 

 <numerator value="1" unit="1"/> 

 <denominator value="1"/> 

 </quantity> 

 <partProduct> 

 <code code="0001-0001" codeSystem="2.16.840.1.113883.6.69"/> 

 <name>Tazmin <suffix>XR</suffix></name> 

 <name use="PHON">Taz-min</name> 

 <formCode code="C42916" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="capsule, extended release"/> 

 <asEntityWithGeneric> 

 <genericMedicine> 

 <name>tazminate hydrochloride</name> 

Validation Procedures 

3.2.8.1 If the product form code is Kit (C47916), then there is one or more parts 

3.2.8.2 If the product has parts, then at least one part has one or more active ingredients. 
3 Product Data Elements

80 

3.2.8.3 Procedures for code, name, dosage form code, source, ingredients, 

characteristics and packaging are the same as for the main products (see 

Sections 3.2.1ff)

3.2.9 Marketing Category 

Example:

<subjectOf> 

 <approval> 

 <id extension="NDA123456" root="2.16.840.1.113883.3.150"/> 

 <code code="C73594" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="NDA"/> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

Validation Procedures 

3.2.9.1 If the marketing category is Exempt device (C80438), Humanitarian Device 

Exemption (C80440), Premarket Application (C80441), or Premarket 

Notification (C80442), then there is at least one part. 

3.2.9.2 If the document type is: OTC Animal Drug Label (50577-6), OTC Type A 

Medicated Article Animal Drug Label (50576-8), OTC Type B Medicated Feed 

Animal Drug Label (50574-3), OTC Type C Medicated Feed Animal Drug Label 

(50573-5), Prescription Animal Drug Label (50578-4), VFD Type A Medicated 

Article Animal Drug Label (50575-0), VFD Type B Medicated Feed Animal 

Drug Label (50572-7), VFD Type C Medicated Feed Animal Drug Label 

(50571-9), or Animal Cells, Tissues, and Cell and Tissue Based Product Label

(98075-5), then the marketing category is: ANADA (C73583), Conditional 

NADA (C73588), NADA (C73593), Legally Marketed Unapproved New Animal 

Drugs for Minor Species (C92556), Unapproved Homeopathic (C73614), 

Unapproved Medical Gas (C73613), Unapproved Drug Other (C73627) or 

Export Only (C73590). 

3.2.9.3 If the marketing category is ANADA (C73583), Conditional NADA (C73588), 

NADA (C73593), then the document type code is: OTC Animal Drug Label 

(50577-6), OTC Type A Medicated Article Animal Drug Label (50576-8), OTC 

Type B Medicated Feed Animal Drug Label (50574-3), OTC Type C Medicated 

Feed Animal Drug Label (50573-5), Prescription Animal Drug Label (50578-4), 

VFD Type A Medicated Article Animal Drug Label (50575-0), VFD Type B 

Medicated Feed Animal Drug Label (50572-7), VFD Type C Medicated Feed 

Animal Drug Label (50571-9), Recombinant Deoxyribonucleic Acid Construct 

Label (78745-7), Intentional Animal Genomic Alteration Label (101437-2), or 

Animal Cells, Tissues, and Cell and Tissue Based Product Label (98075-5). 
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3.2.9.4 If the marketing category is Bulk Ingredient (C73626), Bulk Ingredient for 

Human Prescription Compounding (C96793), or Bulk Ingredient for Animal 

Drug Compounding (C98252), then the document type is Bulk Ingredient

(53409-9) or Bulk Ingredient – Animal drug (81203-2).

3.2.9.5 If the document type is Bulk Ingredient (53409-9), then the marketing category 

is Bulk Ingredient (C73626), Bulk Ingredient for Human Prescription 

Compounding (C96793), or Export Only (C73590).

3.2.9.6 If the code is ANDA (C73584), BLA (C73585), NDA (C73594), Approved Drug 

Product Manufactured under Contract (C132333), NDA authorized generic

(C73605) , Multi-Market Approved Product (C175238), or SIP Approved Drug

(C175462) and the marketing status is active, then there exists a record of an 

application for the application number, except if the document is an Indexing -

Product Concept (73815-3), Indexing - Warning Letter Alert (77288-9) or 

Indexing – Risk Evaluation & Mitigation Strategies (82353-4).

3.2.9.7 If the code is ANDA (C73584), BLA (C73585), NDA (C73594), Approved Drug 

Product Manufactured under Contract (C132333), NDA authorized generic

(C73605) , Multi-Market Approved Product (C175238), or SIP Approved Drug

(C175462) and the marketing is active with a start date on or before the current 

date, then there exists a record of an approved application for the application 

number.

3.2.9.8 If the code is ANDA (C73584), BLA (C73585), NDA (C73594), Approved Drug 

Product Manufactured under Contract (C132333), NDA authorized generic

(C73605) , Multi-Market Approved Product (C175238), or SIP Approved Drug

(C175462) and the marketing status is completed, then there exists a record of 

an approved or withdrawn application for the application number.

3.2.9.9 If the marketing category is Approved Drug Product Manufactured under 

Contract (C132333), OTC Monograph Drug Product Manufactured Under 

Contract (C132334), Unapproved Drug Product Manufactured Under Contract

(C132335), then the document type is Human Prescription Drug Label (34391-

3) or Human OTC Drug Label (34390-5).

3.2.9.10 If the marketing category is Medical Food (C86964), then the document type is 

Medical Food (58475-5), except under parts.

3.2.9.11 If the document type is Medical Food (58475-5), then the marketing category is 

Medical Food (C86964).

3.2.9.12 If the marketing category is Dietary Supplement (C86952), then the document 

type is Dietary Supplement (58476-3), except under parts.
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3.2.9.13 If the document type is Dietary Supplement (58476-3), then the marketing 

category is Dietary Supplement (C86952).

3.2.9.14 If the document type is Human prescription drug label (34391-3), then the 

marketing category is not OTC Monograph Drug Product Manufactured Under 

Contract ( C132334), or OTC Monograph Drug (C200263) except under parts.

3.2.9.15 If the document type is Drug for Further Processing (78744-0), then the 

marketing category is Drug for further processing (C94795) or Export Only

(C73590).

3.2.9.16 If the document type is Bulk ingredient - Animal drug (81203-2), then the 

marketing category is Bulk Ingredient (C73626), (Bulk ingredient for animal 

drug compounding (C98252), Drug for further processing (C94795) or Export 

only (C73590).

3.2.9.17 If the document type is Human Compounded Drug Label (75031-5), then the 

marketing category is Outsourcing Facility Compounded Human Drug Product 

(Exempt From Approval Requirements) (C181659) or Outsourcing Facility 

Compounded Human Drug Product (Not Marketed - Not Distributed)

(C190698).

3.2.9.18 If the document type is Animal Compounded Drug Label (77647-6), then the 

marketing category is unapproved drug other (C73627).

3.2.9.19 If the marketing category is Emergency Use Authorization (C96966), then the 

document type is Human Prescription Drug Label (34391-3) or Vaccine Label 

(53404-0).

3.2.9.20 If the marketing category is Outsourcing Facility Compounded Human Drug 

Product (Exempt From Approval Requirements) (C181659) or Outsourcing 

Facility Compounded Human Drug Product (Not Marketed - Not Distributed)

(C190698), then the document type is Human Compounded Drug Label 

(75031-5).

3.2.10 Marketing Status and Date

The procedures for marketing status and date (if any) are the same for all products 

and described in Section 3.1.8.

Validation Procedures

3.2.10.1 There is one marketing status code for each top-level product (part products do 

not need this), except if the document is a Indexing - Product Concept (73815-3) 

or Lot Distribution Data (66105-8) or Indexing - Biologic or Drug Substance

(77648-4) or Human Compounded Drug Label (75031-5) or Animal 
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Compounded Drug Label (77647-6) or Risk Evaluation & Mitigation Strategies

(82351-8) or Indexing – Risk Evaluation & Mitigation Strategies (82353-4) or if 

the SPL file is for Salvaged Drugs (having business operation as salvage, 

C70827). 

3.2.11 DEA schedule 

The DEA schedule, when applicable, is described under <policy> which is a child of 

<subjectOf> which is a child of <manufacturedProduct> as illustrated in the 

following example of a drug that is schedule II. 

<subjectOf> 

 <policy classCode="DEADrugSchedule"> 

 <code code="C48675" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="CII"/> 

Validation Procedures 

3.2.11.1 If the product item code (NDC) is on the DEA Exempt Products List, then there 

is no DEA schedule. 

3.2.11.2 There is only one DEA schedule element. 

3.2.11.3 If there is a DEA schedule, then the code system is 2.16.840.1.113883.3.26.1.1 

3.2.11.4 Display name matches the code

3.2.11.5 The policy element has a class code of ‘DEADrugSchedule’.

3.2.11.6 If the product item code (NDC) is not on the DEA Exempt Products List, then 

the DEA Schedule matches the one in the Controlled Substance Table where all 

supplied constraints match, except for products regulated by CVM. 

3.2.11.7 If the product item code (NDC) is not on the DEA Exempt Products List and the 

product's active ingredient(s) is in the Controlled Substance Table with DEA 

Schedule CI, CII, CIII, CIV, or CV, and all supplied constraints matching, then 

there is a DEA Schedule, except for products regulated by CVM. 

3.2.12 Solid Oral Drug Product characteristics 

Product characteristics include dosage form appearance. Dosage form characteristics 

are used to describe the appearance of the drug product and include the color, score, 

shape, size, imprint code and image. These are all under <subjectOf> which is a child 

of <manufacturedProduct>. Product characteristics also include product flavor and 

what the product contains. 
3 Product Data Elements

84 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="code for color" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name for color" xsi:type="CE"> 

 <originalText>optional original color description text</originalText> 

 </value> 

 </characteristic> 

</subjectOf> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value value="value for score" xsi:type="INT"/> 

 </characteristic> 

</subjectOf> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="code for shape" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name for shape" xsi:type="CE"> 

 <originalText>optional original shape description text</originalText> 

 </value> 

 </characteristic> 

</subjectOf> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value unit="mm" value="value for size in mm" xsi:type="PQ"/> 

 </characteristic> 

</subjectOf> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="ST">imprint separated by semicolon</value> 

 </characteristic> 

</subjectOf> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="code for flavor" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name for flavor" xsi:type="CE"> 

 <originalText>optional flavor description text</originalText> 

 </value> 

 </characteristic> 

</subjectOf> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLIMAGE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="ED" mediaType="image/jpeg"> 

 <reference value="file name.jpg"/> 

 </value> 

 </characteristic> 

</subjectOf> 

3.2.13 Color 

<subjectOf> 

 <characteristic> 
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 <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="C48333" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="blue" xsi:type="CE"> 

 <originalText>LIGHT BLUE</originalText> 

Validation Procedures 

3.2.13.1 If the dosage form is on the solid oral dosage form list (see FDA SPL web page 

for list https://www.fda.gov/industry/fda-resources-data-standards/structuredproduct-labeling-resources), then there is a color, except if there is no marketing 

status other than new or cancelled. 

3.2.13.2 Code and code system is as above (for SPLCOLOR) 

3.2.13.3 Value code system is 2.16.840.1.113883.3.26.1.1 

3.2.13.4 Display name matches the value code

3.2.14 Shape

<subjectOf> 

 <characteristic> 

 <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="C48336" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="capsule" xsi:type="CE"/> 

 <originalText>capsule like</originalText> 

Validation Procedures 

3.2.14.1 If the dosage form is on the solid oral dosage form list (see FDA SPL web page 

for list https://www.fda.gov/industry/fda-resources-data-standards/structuredproduct-labeling-resources), then there is a shape, except if there is no marketing 

status other than new or cancelled. 

3.2.14.2 Code and code system is as above (for SPLSHAPE) 

3.2.14.3 Value code system is 2.16.840.1.113883.3.26.1.1 

3.2.14.4 Display name matches the value code

3.2.14.5 There is only one shape element

3.2.15 Size

<subjectOf> 

 <characteristic> 

 <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value unit="mm" value="18" xsi:type="PQ"/> 
3 Product Data Elements

86 

Validation Procedures 

3.2.15.1 If the dosage form is on the solid oral dosage form list (see FDA SPL web page 

for list https://www.fda.gov/industry/fda-resources-data-standards/structuredproduct-labeling-resources), then there is a size, except if there is no marketing 

status other than new or cancelled. 

3.2.15.2 Code and code system is as above (for SPLSIZE) 

3.2.15.3 There is a unit and value for size element

3.2.15.4 Value units is mm for size element

3.2.15.5 Value is a whole number greater than zero for size element

3.2.15.6 There is only one size element

3.2.16 Scoring

<subjectOf> 

 <characteristic> 

 <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value value="1" xsi:type="INT"/> 

Validation Procedures 

3.2.16.1 If the dosage form is on the solid oral dosage form list (see FDA SPL web page 

for list https://www.fda.gov/industry/fda-resources-data-standards/structuredproduct-labeling-resources), then there is scoring, except if there is no marketing 

status other than new or cancelled. 

3.2.16.2 Code and code system is as above (for SPLSCORE) 

3.2.16.3 The value is 1, 2, 3, 4 or nullFlavor=”OTH” (for SPLSCORE) 

 <characteristic> 

 <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value nullFlavor=“OTH” xsi:type="INT"/> 

3.2.16.4 There is only one score element

3.2.17 Imprint code 

<subjectOf> 

 <characteristic> 

 <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="ST">05</value> 
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Validation Procedures 

3.2.17.1 Code and code system is as above (for SPLIMPRINT) 

3.2.17.2 Value has only letters and numbers separated by semicolon without spaces (for 

SPLIMPRINT)

3.2.17.3 There is only one imprint code element 

3.2.18 Flavor 

<subjectOf> 

 <characteristic> 

 <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value code="C73391" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="grape" xsi:type="CE"> 

 <originalText>wild grape</originalText> 

Validation Procedures 

3.2.18.1 If there is a flavor, then code and code system is as above 

3.2.18.2 Value code system is 2.16.840.1.113883.3.26.1.1 

3.2.18.3 Display name matches the value code

3.2.19 Image for Solid Oral Dosage Forms

<subjectOf> 

 <characteristic> 

 <code code="SPLIMAGE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="ED" mediaType="image/jpeg"> 

 <reference value="8837a946-1912-4c1f-8035-e313fdd11ef2.jpg"/> 

Validation Procedures 

3.2.19.1 If there is SPL image of the solid oral dosage form, then code and code system 

are as above

3.2.19.2 Value xsi:type is as above

3.2.19.3 mediaType is “image/jpeg”

3.2.19.4 Reference value is the file name for a valid image

3.2.19.5 The image file is submitted together with the SPL file.

3.2.19.6 There are no product characteristics other than the ones mentioned above. 
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88 

3.2.20 Route of administration 

Route of administration may be specified for products 

<subject> 

 <manufacturedProduct> 

 <consumedIn/> 

and their parts:

<part> 

 <consumedIn/> 

Route of administration is specified as follows:

<consumedIn> 

 <substanceAdministration> 

 <routeCode code="C38288" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="oral"/> 

Validation Procedures 

3.2.20.1 If the document type is not for Bulk Ingredient (53409-9), Bulk Ingredient – 

Animal Drug (81203-2), Licensed Vaccine Bulk Intermediate Label (53406-5) or 

Drug for Further Processing (78744-0) and product is not a top-level product 

whose form code is Kit (C47916) or there is no marketing status other than new

or cancelled, then there is one or more route of administration 

(consumedIn/substanceAdministration element with routeCode), except if the 

document type is Indexing - Product Concept (73815-3) or Lot Distribution 

Data (66105-8) or Indexing - Biologic or Drug Substance (77648-4) or Risk 

Evaluation & Mitigation Strategies (82351-8) or Indexing – Risk Evaluation & 

Mitigation Strategies (82353-4) or if the SPL file is for Salvaged Drugs, i.e., 

having business operation as salvage (C70827). 

3.2.20.2 Route code system is 2.16.840.1.113883.3.26.1.1 

3.2.20.3 There is a display name that matches the code

3.2.20.4 If the document type is for Bulk Ingredient (53409-9), Bulk Ingredient – Animal 

Drug (81203-2), Licensed Vaccine Bulk Intermediate Label (53406-5) or Drug 

for Further Processing (78744-0) then route code is not applicable (nullFlavor 

NA) or not present at all. 

 <routeCode nullFlavor="NA"/> 

3.2.20.5 The route (of administration) code cannot be “not applicable” (C48623) for 

document types other than Bulk Ingredient (53409-9), Bulk Ingredient – Animal 

Drug (81203-2), Licensed Vaccine Bulk Intermediate Label (53406-5) , 
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Recombinant Deoxyribonucleic Acid Construct Label (78745-7), Intentional 

Animal Genomic Alteration Label (101437-2), or Drug for Further Processing

(78744-0).

3.3 Device Product

<manufacturedProduct> 

 <code code="91234561234569" codeSystem="1.3.160"/> 

 <name>SuperTape 2000</name> 

 <desc>Adhesive tape for orthopedic use.</desc> 

 <asSpecializedKind classCode="GEN"> 

 <generalizedMaterialKind> 

 <code code="MCA" displayName="Tape, Surgical, Internal" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

Device products are those products with the appropriate marketing categories listed in 

Table 1: Marketing Category and Product Type. 

3.3.1 Item Code and Name 

Validation Procedures 

3.3.1.1 There may be an NDC product/item code 

3.3.1.2 If there is a NDC product/item code, the following general procedures apply: 

3.3.1.3 Code system is 2.16.840.1.113883.6.69 (NHRIC), 1.3.160(GS1), or 

2.16.840.1.113883.6.40 (HIBCC). 

3.3.1.4 Code is compliant with the code system’s allocation rules. 

3.3.1.5 There is a name, i.e., the trade or proprietary name of the medical device as used 

in product labeling or in the catalog 

3.3.1.6 Markings such as ®, or TM should not be included 

3.3.1.7 There is a device type (asSpecializedKind element) with a code. 

3.3.1.8 code system is 2.16.840.1.113883.6.303 for FDA Product Classification System

3.3.1.9 there is a valid medical device product classification code

3.3.1.10 there is a displayName which matches the code
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3.3.2 Additional Device Identifiers 

<document> 

 <section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <asIdentifiedEntity classCode="IDENT"> 

 <id extension="ST2000/A" root="1.2.3.99.1"/> 

 <code code="C99286" displayName="model number" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </asIdentifiedEntity> 

These additional identifiers may also appear under device parts: 

<part> 

 <partProduct> 

 <asIdentifiedEntity> 

3.3.2.1 There may be one or more additional identifiers, including model number

(C99286), catalog number (C99285), and reference number (C99287). 

3.3.2.2 There is a code with code system 2.16.840.1.113883.3.26.1.1. 

3.3.2.3 Code is from the Table 3: Miscellaneous Identifier Types. 

3.3.2.4 There is one id

3.3.2.5 Id has a root OID 

3.3.2.6 The actual identifier is in the extension.

3.3.2.7 There is at most one Model Number reference (C99286)

3.3.2.8 The id root can be any root OID over which the labeler has authority. If the 

labeler has no such root OID of its own, then the root is constructed by 

concatenating the DUNS number (without leading zeroes) to the fixed string 

“1.3.6.1.4.1.32366.3.” 

3.3.2.9 There is at most one Catalog Number (C99285) 

3.3.2.10 The id root can be any root OID over which the labeler has authority. If the 

labeler has no such root OID of its own, then the root is constructed by 

concatenating the DUNS number (without leading zeroes) to the fixed string 

“1.3.6.1.4.1.32366.3.” 

3.3.2.11 The product may have multiple reference numbers (i.e., secondary identifiers, 

C99287). 
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3.3.2.12 The id root is 2.16.840.1.113883.6.69 (NHRIC), 1.3.160 (GS1), 

2.16.840.1.113883.6.40 (HIBCC), or may be constructed by concatenating the 

DUNS number (without leading zeroes) to the fixed string 

“1.3.6.1.4.1.32366.3.” 

3.3.2.13 Id extension is compliant with the code system’s allocation rules.

3.3.3 [RESERVED] 

3.3.4 Device Ingredient

Ingredients included in devices that are not identified as active ingredients include the 

ingredient class code, ingredient name, identifier, and strength. The element 

<ingredient> is a child of <manufacturedProduct>. The class code for ingredient is 

“INGR”. The strength, if needed, is represented as a numerator and denominator and 

is described using UCUM units of measure.

<ingredient classCode="INGR"> 

 <quantity> 

 <numerator value="value" unit="UCUM code"/> 

 <denominator value="value" unit="UCUM code"/> 

 </quantity> 

 <ingredientSubstance> 

 <code code="UNII" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>ingredient name</name> 

 </ingredientSubstance> 

</ingredient> 

This structure is also used to indicate that a product contains latex (UNII code for 

latex).

Note that devices may have active ingredients as well, such as in a medicated stent, 

i.e., where the device serves in part the function of releasing a built-in drug. This is to 

be distinguished from devices such as syringes which are delivery devices for a drug 

product that they contain. 

3.3.5 [RESERVED] 

3.3.6 [RESERVED] 

3.3.7 Device Parts 

Device parts may be specified for the product in the same way as for other product 

kits (see Section 3.1.6 Kits, Parts, Components and Accessories above), 

<partProduct> 

 <code code="91234561234569" codeSystem="1.3.160"/> 
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 <name>SuperTape 2000</name> 

 <asSpecializedKind classCode="GEN"> 

 <generalizedMaterialKind> 

 <code code="MCA" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

Validation Procedures 

3.3.7.1 There is a name, i.e., the trade or proprietary name of the medical device as used 

in product labeling or in the catalog 

3.3.7.2 Markings such as ®, or TM should not be included 

3.3.8 Part of Assembly 

When products are used together but packaged separately, the data element 

<asPartOfAssembly> is used to identify the other product. The products could be 

drugs or devices. 

<asPartOfAssembly> 

 <wholeProduct><!-- this is the assembly, but has no identifier --> 

 <part> 

 <partProduct> 

 <code code="item code of accessory component" 

 codeSystem="code system OID"/> 

3.3.9 Regulatory Identifiers 

Regulatory identifiers, marketing status and characteristics are all connected through 

the <subjectOf> element which may appear on the main product: 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct/> 

 <subjectOf/> 

The regulatory identifier:

<subjectOf> 

 <approval> 

 <id extension="K123456" root="2.16.840.1.113883.3.150"/> 

 <code code="C80442" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="Premarket Notification"/> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 
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Validation Procedures

3.3.9.1 There is one regulatory identifier for each product 

3.3.9.2 Code comes from Table 1 for product type “device”.

3.3.9.3 Display name matches the code

3.3.9.4 Code system is 2.16.840.1.113883.3.26.1.1

3.3.9.5 If the marketing category (code) is Premarket Application (C80441), 510(k) 

Premarket Notification (C80442), Exempt Device (C80438), or Humanitarian 

Device Exemption (C80440), then the id root is 2.16.840.1.113883.3.150.

3.3.9.6 If the marketing category (code) is Premarket Application (C80441), then the id 

extension has a prefix “P” or “BP” followed by 6 digits

3.3.9.7 If the marketing category (code) is Premarket Notification (C80442), then the id 

extension has a prefix “K” or “BK” followed by 6 digits.

3.3.9.8 If the marketing category (code) is Exempt Device (C80438), then the id 

extension consists of 3 letters

3.3.9.9 If the marketing category (code) is Humanitarian Device Exemption (C80440), 

then the id extension has a prefix “H” followed by 6 digits

3.3.9.10 Territorial authority is as above

3.3.9.11 If the form code is kit (C47916) and the top/kit-level marketing category is 

Exempt device (C80438), Humanitarian Device Exemption (C80440), 

Premarket Application (C80441) or Premarket Notification (C80442), then the 

document type is not Bulk Ingredient (53409-9), Cellular Therapy (60684-8),

Drug for Further Processing (78744-0), Human OTC Drug Label (34390-5),

Human Prescription Drug Label (34391-3), License Blood Intermediates/Paste 

Label (53407-3), Licensed Minimally Manipulated Cells Label (53408-1),

Licensed Vaccine Bulk Intermediate Label (53406-5), Non-Standardized 

Allergenic Label (53405-7), OTC Type A Medicated Article Animal Drug Label

(50576-8), OTC Type C Medicated Feed Animal Drug Label (50573-5), Plasma 

Derivative (60683-0), Prescription Animal Drug Label (50578-4), Standardized 

Allergenic (60682-2), Vaccine Label (53404-0), Animal Cells, Tissues, and Cell 

and Tissue Based Product Label (98075-5), OTC Animal Drug Label (50577-6), 

Recombinant Deoxyribonucleic Acid Construct Label (78745-7), Intentional 

Animal Genomic Alteration Label (101437-2), VFD Type A Medicated Article 

Animal Drug Label (50575-0), VFD Type B Medicated Feed Animal Drug Label

(50572-7), VFD Type C Medicated Feed Animal Drug Label (50571-9), Animal 
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Compounded Drug Label (77647-6), Bulk Ingredient - Animal Drug (81203-2), 

or Human Compounded Drug Label (75031-5).

3.3.9.12 If the form code is not kit (C47916) and the document type is Bulk Ingredient

(53409-9), Cellular Therapy (60684-8), Drug for Further Processing (78744-0), 

Human OTC Drug Label (34390-5), Human Prescription Drug Label (34391-3), 

License Blood Intermediates/Paste? Label (53407-3), Licensed Minimally 

Manipulated Cells Label (53408-1), Licensed Vaccine Bulk Intermediate Label

(53406-5), Non-Standardized Allergenic Label (53405-7), OTC Type A 

Medicated Animal Drug Label (50576-8), OTC Type C Medicated Feed Animal 

Drug Label (50573-5), Plasma Derivative (60683-0), Prescription Animal Drug 

Label (50578-4), Standardized Allergenic (60682-2), or Vaccine Label (53404-

0), Animal Cells, Tissues, and Cell and Tissue Based Product Label (98075-5), 

OTC Animal Drug Label (50577-6), Recombinant Deoxyribonucleic Acid 

Construct Label (78745-7), Intentional Animal Genomic Alteration Label 

(101437-2), VFD Type A Medicated Article Animal Drug Label (50575-0), VFD 

Type B Medicated Feed Animal Drug Label (50572-7), VFD Type C Medicated 

Feed Animal Drug Label (50571-9), Animal Compounded Drug Label (77647-

6), Bulk Ingredient - Animal Drug (81203-2), or Human Compounded Drug 

Label (75031-5), then the marketing category is not Exempt device (C80438), 

Humanitarian Device Exemption (C80440), Premarket Application (C80441) or 

Premarket Notification (C80442). 

3.3.10 Marketing status and date 

The procedures for marketing status and date (if any) are the same for all products 

and described in Section 3.1.8. 

Validation Procedures 

3.3.10.1 There is one marketing status code for each top-level product (part products do 

not need this) 

3.3.11 Device Characteristics 

Many characteristics exist for devices and are listed here in tabular form. The 

characteristic structure allows specifying any properties of the product in a codevalue pair, the code saying which property is being specified, the value saying what 

the property is for the given product. The characteristics structure connects to the 

product Role through the subjectOf element. 

<manufacturedProduct> 

 <manufacturedProduct> 

 ... 

 </manufacturedProduct> 
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 <subjectOf> 

 <characteristic> 

 <code code="characteristic code" 

 codeSystem="characteristic code system"/> 

 <value xsi:type="characteristic value type" ...> 

Characteristics listed in Table 6 use one of a number of different data types. Each data 

type uses slightly different XML elements and attributes as shown in the templates in 

Section 3.1.8.34 

Table 6: Characteristic codes and code systems.

Name Code / Code System OID Data 

Type

Description

Number of times 

useable.

SPLUSE 

2.16.840.1.113883.1.11.19255

INT Specifies how often a product may be reused. While a number could be specified, 

the common distinction is between single 

disposable and multiple use products. A 

product that has unlimited reuses uses the 

<value nullFlavor=”PINF” xsi:type=”INT”/>.

Sterile Use SPLSTERILEUSE 

2.16.840.1.113883.1.11.19255

BL Specifies whether the device is intended or 

not intended to be used where sterile 

conditions are necessary (e.g., pens).

MRI Safety SPLMRISAFE 

2.16.840.1.113883.1.11.19255

BL Yes (MRI Safe), No (MRI unsafe)

Validation Procedures 

3.3.11.1 There are no device characteristics other than the ones mentioned in this 

document. 

3.3.12 Reusability 

<subjectOf> 

 <characteristic> 

 <code code="SPLUSE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value value="1" xsi:type="INT"/> 

Unlimited reusability is represented as follows:

<subjectOf> 

 <characteristic> 

 <code code="SPLUSE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value nullFlavor=“PINF” xsi:type=“INT”/>. 

Validation Procedures 

3.3.12.1 Code and code system is as above

3.3.12.2 The value is an integer number greater or equal 1 (1 meaning single use, and 

number greater than 1 meaning reusable up to this many times) or there is 

nullFlavor “PINF” and no value. 
3 Product Data Elements

96 

3.3.12.3 There is only one reusability element

3.3.13 [RESERVED] 

3.3.14 Sterile Use 

<subjectOf> 

 <characteristic> 

 <code code="SPLSTERILEUSE" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type=“BL” value="true"/> 

Validation Procedures 

3.3.14.1 Code and code system are as above 

3.3.14.2 Value type is “BL” (Boolean)

3.3.14.3 Value is “true” or “false”

3.4 Cosmetic Product

Cosmetic products are those products with marketing category C86965 (cosmetic) or 

any product inside a document of type Cosmetic Product Listing (103572-4), or 

Cosmetic Facility Registration (103573-2), Cosmetic Facility Registration – 

Amendment (X8888-1), or Cosmetic – Update (X8888-5). 

3.4.1 Cosmetic Product Item Code

<manufacturedProduct> 

 <manufacturedProduct> 

 <code .../> 

 <name>Juvenia Soft</name> 

Validation Procedures 

3.4.1.1 If the document is a Cosmetic Product Listing, then the item code is a cosmetic 

product listing number (see Section 36.2.2.1 and following). 

3.4.1.2 If the document is not a Cosmetic Product Listing or Cosmetic Facility 

Registration, then the item code should be a GS1 GTIN. 

3.4.1.3 If the document is a Cosmetic Facility Registration, then there is no item code. 

3.4.2 Cosmetic Product Name

The product name is the statement of identity, as such name appears on the label. If 

the product names in the listing are not unique, then also include distinguishing 

information for identification purposes, for example brand name or a code that the 
SPL Implementation Guide with Validation Procedures v1

97 

responsible person uses to distinguish the product. Such information may also be 

included in addition to the product name even when product names in the listing are 

unique. If you believe certain distinguishing information is confidential, include that 

distinguishing information in parenthesis. 

<manufacturedProduct> 

 <manufacturedProduct> 

 <code .../> 

 <name>Juvenia Soft</name> 

Validation Procedures 

3.4.2.1 There is a name, i.e., the product name of the cosmetic as used in product 

labeling or in the catalog. 

3.4.2.2 Markings such as ®, or TM should not be included 

3.4.3 Cosmetic Product Category 

<manufacturedProduct> 

 <manufacturedProduct> 

 <code .../> 

 <name .../> 

 <asSpecializedKind classCode="GEN"> 

 <generalizedMaterialKind> 

 <code code="01B" displayName="lotions, oils, powders, and creams" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

3.4.3.1 There are one or more cosmetic product category codes (asSpecializedKind 

element) with a code. 

3.4.3.2 code system is 2.16.840.1.113883.6.303 for FDA Product Classification System 

3.4.3.3 there is a valid cosmetic product category code 

3.4.3.4 there is a displayName which matches the code

3.4.3.5 If one cosmetic product category code is “Other baby products, leave-on [Baby 

products]” (01D1), then another cannot be “Other baby products, rinse-off 

[Baby products]” (01D2), except if the document type is Cosmetic Facility 

Registration (103573-2), Cosmetic Facility Registration - Amendment (X8888-

1) and Cosmetic Facility Registration - Biennial Renewal (X8888-4).

3.4.3.6 If one cosmetic product category code is “Other baby products, rinse-off [Baby 

products]” (01D2), then another cannot be “Other baby products, leave-on 

[Baby products]” (01D1), except if the document type is Cosmetic Facility 

Registration (103573-2), Cosmetic Facility Registration - Amendment (X8888-

1) and Cosmetic Facility Registration - Biennial Renewal (X8888-4). 
3 Product Data Elements

98

3.4.3.7 If one cosmetic product category code is “Shampoos (non-coloring), leave-on 

[Hair preparations (non-coloring)]” (06F1), then another cannot be “Shampoos 

(non-coloring), rinse-off [Hair preparations (non-coloring)]” (06F2), except if 

the document type is Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration - Amendment (X8888-1) and Cosmetic Facility 

Registration - Biennial Renewal (X8888-4).

3.4.3.8 If one cosmetic product category code is “Shampoos (non-coloring), rinse-off 

[Hair preparations (non-coloring)]” (06F2), then another cannot be “Shampoos 

(non-coloring), leave-on [Hair preparations (non-coloring)]” (06F1), except if 

the document type is Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration - Amendment (X8888-1) and Cosmetic Facility 

Registration - Biennial Renewal (X8888-4).

3.4.3.9 If one cosmetic product category code is “Other hair preparations, leave-on 

[Hair preparations (non-coloring)]” (06I1), then another cannot be “Other hair 

preparations, rinse-off [Hair preparations (non-coloring)]” (06I2), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration -

Biennial Renewal (X8888-4).

3.4.3.10 If one cosmetic product category code is “Other hair preparations, rinse-off 

[Hair preparations (non-coloring)]” (06I2), then another cannot be “Other hair 

preparations, leave-on [Hair preparations (non-coloring)]” (06I1), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration -

Biennial Renewal (X8888-4).

3.4.3.11 If one cosmetic product category code is “Hair rinses (coloring), leave-on [Hair 

coloring preparations]” (07C1), then another cannot be “Hair rinses (coloring), 

rinse-off [Hair coloring preparations]” (07C2), except if the document type is 

Cosmetic Facility Registration (103573-2), Cosmetic Facility Registration -

Amendment (X8888-1) and Cosmetic Facility Registration - Biennial Renewal

(X8888-4).

3.4.3.12 If one cosmetic product category code is “Hair rinses (coloring), rinse-off [Hair 

coloring preparations]” (07C2), then another cannot be “Hair rinses (coloring), 

leave-on [Hair coloring preparations]” (07C1), except if the document type is 

Cosmetic Facility Registration (103573-2), Cosmetic Facility Registration -

Amendment (X8888-1) and Cosmetic Facility Registration - Biennial Renewal

(X8888-4).

3.4.3.13 If one cosmetic product category code is “Hair shampoos (coloring), leave-on 

[Hair coloring preparations]” (07D1), then another cannot be “Hair shampoos 

(coloring), rinse-off [Hair coloring preparations]” (07D2), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 
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99

Registration - Amendment (X8888-1) and Cosmetic Facility Registration -

Biennial Renewal (X8888-4).

3.4.3.14 If one cosmetic product category code is “Hair shampoos (coloring), rinse-off 

[Hair coloring preparations]” (07D2), then another cannot be “Hair shampoos 

(coloring), leave-on [Hair coloring preparations]” (07D1), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration -

Biennial Renewal (X8888-4).

3.4.3.15 If one cosmetic product category code is “Other hair coloring preparations, 

leave-on [Hair coloring preparations]” (07I1), then another cannot be “Other 

hair coloring preparations, rinse-off [Hair coloring preparations]” (07I2), except 

if the document type is Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration - Amendment (X8888-1) and Cosmetic Facility 

Registration - Biennial Renewal (X8888-4).

3.4.3.16 If one cosmetic product category code is “Other hair coloring preparations, 

rinse-off [Hair coloring preparations]” (07I2), then another cannot be “Other 

hair coloring preparations, leave-on [Hair coloring preparations]” (07I1), except 

if the document type is Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration - Amendment (X8888-1) and Cosmetic Facility 

Registration - Biennial Renewal (X8888-4).

3.4.3.17 If one cosmetic product category code is “Feminine deodorants, leave-on 

[Personal cleanliness]” (12D1), then another cannot be “Feminine deodorants, 

rinse-off [Personal cleanliness]” (12D2), except if the document type is 

Cosmetic Facility Registration (103573-2), Cosmetic Facility Registration -

Amendment (X8888-1) and Cosmetic Facility Registration - Biennial Renewal

(X8888-4).

3.4.3.18 If one cosmetic product category code is “Feminine deodorants, rinse-off 

[Personal cleanliness]” (12D2), then another cannot be “Feminine deodorants, 

leave-on [Personal cleanliness]” (12D1), except if the document type is 

Cosmetic Facility Registration (103573-2), Cosmetic Facility Registration -

Amendment (X8888-1) and Cosmetic Facility Registration - Biennial Renewal

(X8888-4).

3.4.3.19 [RESERVED].

3.4.3.20 If one cosmetic product category code is “Other personal cleanliness products, 

leave-on [Personal cleanliness]” (12F1), then another cannot be “Other personal 

cleanliness products, rinse-off [Personal cleanliness]” (12F2), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration -

Biennial Renewal (X8888-4).
3 Product Data Elements

100

3.4.3.21 [RESERVED].

3.4.3.22 If one cosmetic product category code is “Other personal cleanliness products, 

rinse-off [Personal cleanliness]” (12F2), then another cannot be “Other personal 

cleanliness products, leave-on [Personal cleanliness]” (12F1), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration -

Biennial Renewal (X8888-4).

3.4.3.23 If one cosmetic product category code is “Face and neck (excluding shaving 

preparations), leave-on [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14C1), then another cannot be “Face and neck (excluding shaving 

preparations), rinse-off [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14C2), except if the document type is Cosmetic Facility Registration

(103573-2), Cosmetic Facility Registration - Amendment (X8888-1) and 

Cosmetic Facility Registration - Biennial Renewal (X8888-4).

3.4.3.24 If one cosmetic product category code is “Face and neck (excluding shaving 

preparations), rinse-off [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14C2), then another cannot be “Face and neck (excluding shaving 

preparations), leave-on [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14C1), except if the document type is Cosmetic Facility Registration

(103573-2), Cosmetic Facility Registration - Amendment (X8888-1) and 

Cosmetic Facility Registration - Biennial Renewal (X8888-4).

3.4.3.25 If one cosmetic product category code is “Body and hand (excluding shaving 

preparations), leave-on [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14D1), then another cannot be “Body and hand (excluding shaving 

preparations), rinse-off [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14D2), except if the document type is Cosmetic Facility Registration

(103573-2), Cosmetic Facility Registration - Amendment (X8888-1) and 

Cosmetic Facility Registration - Biennial Renewal (X8888-4).

3.4.3.26 If one cosmetic product category code is “Body and hand (excluding shaving 

preparations), rinse-off [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14D2), then another cannot be “Body and hand (excluding shaving 

preparations), leave-on [Skin care preparations (creams, lotions, powder, and 

sprays)]” (14D1), except if the document type is Cosmetic Facility Registration

(103573-2), Cosmetic Facility Registration - Amendment (X8888-1) and 

Cosmetic Facility Registration - Biennial Renewal (X8888-4).

3.4.3.27 If one cosmetic product category code is “Other skin care preparations, leave-on 

[Skin care preparations (creams, lotions, powder, and sprays)]” (14J1), then 

another cannot be “Other skin care preparations, rinse-off [Skin care 

preparations (creams, lotions, powder, and sprays)]” (14J2), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 
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101 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration - 

Biennial Renewal (X8888-4).

3.4.3.28 If one cosmetic product category code is “Other skin care preparations, rinse-off 

[Skin care preparations (creams, lotions, powder, and sprays)]” (14J2), then 

another cannot be “Other skin care preparations, leave-on [Skin care 

preparations (creams, lotions, powder, and sprays)]” (14J1), except if the 

document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration - 

Biennial Renewal (X8888-4).

3.4.3.29 If one cosmetic product category code is “Hair Conditioners (non-coloring), 

leave-on [Hair preparations]” (06A1), then another cannot be “Hair Conditioners 

(non-coloring), rinse-off [Hair preparations]” (06A2), except if the document 

type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration - 

Biennial Renewal (X8888-4).

3.4.3.30 If one cosmetic product category code is “Hair Conditioners (non-coloring), 

rinse-off [Hair preparations]” (06A2), then another cannot be “Hair Conditioners 

(non-coloring), leave-on [Hair preparations]” (06A1), except if the document 

type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1) and Cosmetic Facility Registration - 

Biennial Renewal (X8888-4).

3.4.4 Cosmetic Ingredient 

Cosmetic ingredients use the class code INGR, or COLR for color additives. The 

ingredients are included in the order as in the label, i.e., generally descending order of 

predominance, with an alternative grouping as per 21 CFR 701.3(f). 

<ingredient classCode="INGR"> 

 <ingredientSubstance> 

 <code code="UNII" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>ingredient name</name> 

 </ingredientSubstance> 

</ingredient> 

Validation Procedures 

3.4.4.1 Class code for cosmetic ingredients is INGR or COLR

3.4.4.2 [RESERVED] 

3.4.4.3 [RESERVED]

3.4.4.4 If the document type is one of the Cosmetic Facility Registrations (see Section 

35), then there are no ingredients. 
3 Product Data Elements

102 

3.4.4.5 For cosmetics the ingredient substance (UNII) code is optional. 

3.4.4.6 There may be one ingredient specified as flavor(s) by ingredient name simply 

“flavor” or “flavors” without a UNII code. 

<ingredient classCode="INGR"> 

 <ingredientSubstance> 

 <name>flavors</name> 

 </ingredientSubstance> 

</ingredient> 

3.4.4.7 There may be one ingredient specified as fragrance(s) by ingredient name 

simply “fragrance” or “fragrances” without a UNII code. 

<ingredient classCode="INGR"> 

 <ingredientSubstance> 

 <name>fragrances</name> 

 </ingredientSubstance> 

</ingredient> 

3.4.4.8 Cosmetic Product Listing documents (see Section 36) have no ingredient 

quantity. 

3.4.5 Cosmetic Parts 

Cosmetic parts may be specified for the product in the same way as for other product 

kits (see Section 3.1.6 Kits, Parts, Components and Accessories above), 

<partProduct> 

 <code code="91234561234569" codeSystem="1.3.160"/> 

 <name>Juvenia Soft</name> 

 <asSpecializedKind classCode="GEN"> 

 <generalizedMaterialKind> 

 <code code="MCA" 

 codeSystem="2.16.840.1.113883.6.303"/> 

 </generalizedMaterialKind> 

 </asSpecializedKind> 

Note that in cosmetic product listing (Section 36) kits with parts are currently not 

expected.

Validation Procedures 

3.4.5.1 There is a name, i.e., the trade or proprietary name of the cosmetic as used in 

product labeling or in the catalog 

3.4.5.2 Markings such as ®, or TM should not be included 
SPL Implementation Guide with Validation Procedures v1

103 

3.4.6 Marketing status and date 

The procedures for marketing status and date (if any) are the same for all products 

and described in Section 3.1.8, except that products listed in cosmetic product listing 

documents do not require a marketing status unless discontinued. 

Validation Procedures 

3.4.6.1 There is one marketing status code for each top-level product (part products do 

not need this), except if the document is a cosmetic product listing or cosmetics 

facility registration.

3.4.6.2 If the document is a cosmetics facility registration, then there is no marketing

status.

3.4.6.3 If the document is a cosmetic product listing and the product is to be 

discontinued, then there is a marketing status code of “completed”. 

3.4.7 Product Web Page Link 

Web page to the product may be provided with an absolute URL reference with the 

“http://” or https://” protocol as follows:

<subjectOf> 

 <document> 

 <text> 

 <reference value="https://aux-supreme.com/eau-claire.html"/> 

 </text> 

 </document> 

Validation Procedures 

3.4.7.1 Web page reference has a text element with reference (text reference) but no 

mediaType.

3.4.7.2 Text reference value is an absolute URL, starting with a URL scheme “http://” 

or “https://”. 

3.4.7.3 There are no elements other than text.

3.4.8 Professional Use 

To indicate that the cosmetic product is intended for use by professionals only, 

include the following characteristic:

<subject> 

 <manufacturedProduct> 

 ... 
3 Product Data Elements

104 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLPROFESSIONALUSE" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="BL" value="true"/> 

 </characteristic> 

</subjectOf> 

3.4.8.1 Code and code system is as above (“SPLPROFESSIONALUSE”)

3.4.8.2 There is a Boolean value is “true”. 

3.4.8.3 Value may be “true” (professional use); to indicate general use, omit this 

property. 

3.4.9 Image of Label for Cosmetics 

<subjectOf> 

 <characteristic> 

 <code code="SPLIMAGE" codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="ED" mediaType="image/jpeg"> 

 <reference value="shampoo-bottle-sticker.jpg"/> 

Validation Procedures 

3.4.9.1 There may be one or more images of labels with the characteristic code and code 

system are as above. 

3.4.9.2 Value xsi:type is as above

3.4.9.3 mediaType is “image/jpeg”

3.4.9.4 Reference value is the file name for a valid image

3.4.9.5 The image file is submitted together with the SPL file.

3.4.9.6 There are no product characteristics other than the ones mentioned above. 

3.5 Summary of Product Data Elements

This concludes the specific data elements recognized about various types of products. 

The following sections describe specific business processes which may or may not 

contain the above product data element structures.

Validation Procedures 

3.5.1.1 There are no products or parts that do not follow the validation procedures for 

the major types described in this section, except if there is no marketing status 

other than new or cancelled. 
SPL Implementation Guide with Validation Procedures v1

105

4 Drug and Biologics Labeling, Listing, and other Product 

Submissions

Drug labeling provides a description of the product and information for its use. Drug 

listing links registered establishments to specific products.

4.1 Header

4.1.1 Document Type

4.1.1.1 Document types for labeling and listing are in the following Table 7. Some 

validation procedures vary by which FDA Center has authority over the types of 

products submitted with the respective document.

Table 7: Document Types for Labeling , Listing, and other Product Submissions 

Code Display Name FDA Center

53409-9 BULK INGREDIENT CDER

81203-2 BULK INGREDIENT – ANIMAL DRUG CVM

60684-8 CELLULAR THERAPY CBER

58474-8 COSMETIC CFSAN

103572-4 COSMETIC PRODUCT LISTING CFSAN

58476-3 DIETARY SUPPLEMENT CFSAN

34390-5 HUMAN OTC DRUG LABEL CDER

34391-3 HUMAN PRESCRIPTION DRUG LABEL, except if the 

application number prefix is “BN” or “BA”

CDER

34391-3 HUMAN PRESCRIPTION DRUG LABEL if the application 

number prefix is “BN” or “BA”

CBER

75031-5 HUMAN COMPOUDED DRUG LABEL CDER

101437-2 INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL CVM

53407-3 LICENSE BLOOD INTERMEDIATES/PASTE LABEL CBER

53408-1 LICENSED MINIMALLY MANIPULATED CELLS LABEL CBER

53406-5 LICENSED VACCINE BULK INTERMEDIATE LABEL CBER

55439-4 MEDICAL DEVICE CDRH

58475-5 MEDICAL FOOD CFSAN

53405-7 NON-STANDARDIZED ALLERGENIC LABEL CBER

50577-6 OTC ANIMAL DRUG LABEL CVM

69403-4 OTC MEDICAL DEVICE LABEL CDRH

50576-8 OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL CVM

50574-3 OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL CVM

50573-5 OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL CVM

60683-0 PLASMA DERIVATIVE CBER

50578-4 PRESCRIPTION ANIMAL DRUG LABEL CVM

69404-2 PRESCRIPTION MEDICAL DEVICE LABEL CDRH

60682-2 STANDARDIZED ALLERGENIC CBER

53404-0 VACCINE LABEL CBER

50575-0 VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL CVM

50572-7 VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL CVM

50571-9 VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL CVM
4 Drug and Biologics Labeling, Listing, and other Product Submission

106 

78745-7 RECOMBINANT DEOXYRIBONUCLEIC ACID CVM

77647-6 ANIMAL COMPOUNDED DRUG CVM

78744-0 DRUG FOR FURTHER PROCESSING CDER

98075-5 ANIMAL CELLS, TISSUES, AND CELL AND TISSUE BASED 

PRODUCT LABEL

CVM

4.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type, except if the previous document type was Bulk Ingredient

(53409-9) or Bulk ingredient – Animal drug (81203-2) and the present document 

type is Drug for Further Processing (78744-0).

4.1.1.3 If any active ingredient code is on the list of active ingredients approved for 

vaccines, then the document type code is Vaccine Label (53404-0) or Licensed 

Vaccine Bulk Intermediate Label (53406-5), except if the strength unit is a 

homeopathic unit. 

4.1.1.4 If the document type changes from Human Prescription Drug Label (34391-3) 

to Human OTC Drug Label (34390-5), then submit a new listing file with new 

NDC product codes for the OTC drug. 

4.1.2 Labeler information 

<document> 

 <code code="..." codeSystem="2.16.840.1.113883.6.1" 

 displayName="..."/> 

<author> 

<assignedEntity> 

 <representedOrganization> 

 <id extension="100000007" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

Validation Procedures 

4.1.2.1 There is one labeler. 

4.1.2.2 There is one id, the labeler’s DUNS number, and name is as in Section 2.1.5. 

4.1.2.3 The set id is not associated with any top level product with a different NDC 

Labeler Prefix

4.1.2.4 There is no other element besides id (the labeler’s DUNS Number), name and 

registrant.

4.1.3 Registrant information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 
SPL Implementation Guide with Validation Procedures v1

107 

<assignedEntity> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

 <assignedOrganization> 

 <id extension="100000008" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

Validation Procedures 

4.1.3.1 There may be registrant information

4.1.3.2 If there is a registrant, then there is one id, (the registrants DUNS number) and a 

name as in Section 2.1.5. 

4.1.3.3 There is no other element besides registrant’s id, registrant’s name and 

establishments.

4.1.3.4 There is not more than one registrant element.

4.1.4 Establishment information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> <!-- Labeler --> 

 <assignedEntity> 

 <assignedOrganization> <!-- Registrant --> 

<assignedEntity> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

 <assignedOrganization> <!-- Establishment --> 

 <id extension="1000000019" root="1.3.6.1.4.1.519.1"/> 

 <name>Middleton Manufacturing company</name> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C43360" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

Validation Procedures 

4.1.4.1 If the marketing status code for any of the products that is or includes a drug is 

active, then there are one or more establishments.

4.1.4.2 There is one id (the DUNS number) and name is as in Section 2.1.5. 

4.1.4.3 Id (DUNS Number) is not used for other establishments in the file 

4.1.4.4 Establishment (“assignedOrganization”) has no other element besides id (the 

DUNS Number) and name. 
4 Drug and Biologics Labeling, Listing, and other Product Submission

108

4.1.4.5 The establishment id (DUNS Number) has been submitted in a document of type 

Establishment Registration (51725-0) on or after October 1st of the previous 

year, or, if earlier, that Establishment Registration has been followed by a 

document of type No Change Notification (53410-7) between October 1st and 

December 31st of the previous or the current year, and that has not been 

inactivated by an FDA Agency Initiated Compliance Action, except if all 

products have the marketing status completed.

4.1.4.6 There are one or more business operations.

4.1.4.7 Business operation name (act definition code display name) matches 

corresponding business operation code

4.1.4.8 The code comes from the business operations list except for Import (C73599), 

United States Agent (C73330), Distributes Drug Products under own Private 

Label (C73608), API/FDF Analytical Testing (C101509), Clinical 

Bioequivalence or Bioavailability Study (C101511), FDF Manufacture

(C101510), In Vitro Bioequivalence or Bioanalytical Testing (C101512), 

Wholesale Drug Distributor (C118411), and Third-Party Logistics Provider

(C118412).

4.1.4.9 Business operation code matches a business operation code for the establishment 

with same id in its most recent establishment registration.

4.1.4.10 If any of the products without a marketing completion date in a Prescription 

Animal Drug Label (50578-4), Animal Cells, Tissues, and Cell and Tissue 

Based Product Label (98075-5), OTC Animal Drug Label (50577-6) or Animal 

Medicated Article or Medicated Feed Label (50576-8, 50574-3, 50573-5, 

50575-0, 50572-7, 50571-9) has establishments with operations of manufacture

(C43360) and also relabel (C73607), or repack (C73606), then there is no 

product source.

4.1.4.11 If the document type is Human Compounded Drug Label (75031-5), then the 

establishment’s business operation is Human drug compounding outsourcing 

facility (C112113).

4.1.4.12 If the document type is Animal Compounded Drug Label (77647-6), then the 

establishment’s business operation is Outsourcing Animal Drug Compounding

(C122061).

4.1.4.13 If the product has a product source reference (source NDC product code), then 

one of the operations is Repack (C73606) or Relabel (C73607) except if the SPL 

file is for Salvaged Drugs, i.e. having business operation as salvage (C70827).

4.1.4.14 If in a Bulk Ingredient (53409-9) or Bulk ingredient – Animal Drug (81203-2) 

listing there is a product with marketing category Bulk Ingredient (C73626) and 
SPL Implementation Guide with Validation Procedures v1

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without a marketing completion date, then one or more establishments with 

operation of API Manufacture (C82401) are included.

4.1.4.15 If there is any product that is or includes a drug or biologic and has no marketing 

completion date and no product source, then at least one establishment with a 

manufacture operation is included such as API Manufacture (C82401), 

Manufacture (C43360), or Positron Emission Tomography Drug Production

(C91403).

4.1.4.16 If in a Prescription Animal Drug Label (50578-4), OTC Animal Drug Label

(50577-6) or Animal Medicated Article or Medicated Feed Label (50576-8, 

50574-3, 50573-5, 50575-0, 50572-7, 50571-9) there is a product without a 

marketing completion date, with an active ingredient other than those in the 

designated medical gas validation list, and without product source, then one or 

more establishments with operation of API Manufacture (C82401) are included.

4.1.4.17 If the marketing status code for any of the products that is or includes a drug is 

completed and the document type and marketing categories are as follows, then 

there are one or more establishments. For document type Bulk Ingredient

(53409-9) the marketing category Bulk Ingredient for Human Prescription 

Compounding (C96793); for document type Human OTC Drug Label (34390-5) 

the marketing categories OTC Monograph Drug Product Manufactured Under 

Contract (C132334), Unapproved Drug Other (C73627), Unapproved Drug 

Homeopathic (C73614), Unapproved Drug Product Manufactured Under 

Contract (C132335), and OTC Monograph Drug (C200263); for document type 

Human Prescription Drug Label (34391-3) the marketing categories Approved 

Drug Product Manufactured Under Contract (C132333), NDA Authorized 

Generic (C73605), Export Only (C73590), ANDA (C73584), BLA (C73585), 

IND (C75302), NDA (C73594), Unapproved Drug for Use in Drug Shortage

(C101533), Unapproved Homeopathic (C73614), Unapproved Medical Gas

(C73613), Unapproved Drug Other (C73627), and Unapproved Drug Product 

Manufactured Under Contract (C132335); and for the marketing category BLA

(C73585) the document types License Blood Intermediates/Paste Label (53407-

3), Licensed Minimally Manipulated Cells Label (53408-1), Cellular Therapy

(60684-8), Licensed Vaccine Bulk Intermediate Label (53406-5), NonStandardized Allergenic Label (53405-7), Plasma Derivative (60683-0), 

Standardized Allergenic (60682-2), and Vaccine Label (53404-0).

Table 8: Document Types and Marekting Categories for which even completed product listings 

should have establishments. 

GRP Document Type DTCode Marketing Category MCCode

Name Code Name Code

1 Bulk Ingredient 53409-9 Bulk Ingredient for Human 

Prescription Compounding

C96793

2 Cellular Therapy 60684-8 BLA C73585
4 Drug and Biologics Labeling, Listing, and other Product Submission

110

3 Human OTC Drug Label 34390-5 OTC Monograph Drug Product 

Manufactured Under Contract

C132334

3 Human OTC Drug Label 34390-5 Unapproved Drug Other C73627

3 Human OTC Drug Label 34390-5 Unapproved Drug 

Homeopathic

C73614

3 Human OTC Drug Label 34390-5 Unapproved Drug Product 

Manufactured Under Contract

C132335

3 Human OTC Drug Label 34390-5 OTC Monograph Drug C200263

4 Human Prescription Drug Label 34391-3 Approved Drug Product 

Manufactured Under Contract

C132333

4 Human Prescription Drug Label 34391-3 NDA Authorized Generic C73605

4 Human Prescription Drug Label 34391-3 Export Only C73590

4 Human Prescription Drug Label 34391-3 ANDA C73584

4 Human Prescription Drug Label 34391-3 BLA C73585

4 Human Prescription Drug Label 34391-3 IND C75302

4 Human Prescription Drug Label 34391-3 NDA C73594

4 Human Prescription Drug Label 34391-3 Unapproved Drug for Use in 

Drug Shortage

C101533

4 Human Prescription Drug Label 34391-3 Unapproved Homeopathic C73614

4 Human Prescription Drug Label 34391-3 Unapproved Medical Gas C73613

4 Human Prescription Drug Label 34391-3 Unapproved Drug Other C73627

4 Human Prescription Drug Label 34391-3 Unapproved Drug Product 

Manufactured Under Contract

C132335

5 License Blood Intermediates/Paste 

Label

53407-3 BLA C73585

6 Licensed Minimally Manipulated Cells 

Label

53408-1 BLA C73585

7 Licensed Vaccine Bulk Intermediate 

Label

53406-5 BLA C73585

8 Non-Standardized Allergenic Label 53405-7 BLA C73585

9 Plasma Derivative 60683-0 BLA C73585

10 Standardized Allergenic 60682-2 BLA C73585

11 Vaccine Label 53404-0 BLA C73585

4.1.4.18 DUNS Number is not associated with any other set id for Compounded Drug 

report.

4.1.4.19 If the marketing category is OTC Monograph Drug Product Manufactured 

Under Contract (C132334), OTC Monograph Drug (C200263) and business 

operations is label (C84732), manufacture (C43360), pack (C84731), relabel

(C73607), or repack (C73606), then one or more establishment ids (DUNS 

Numbers) matches an establishment with same id (DUNS Number) submitted in 

documents of type Establishment Registration (51725-0) in the same or previous 

calendar year which is associated with one or more of the business operation 

qualifiers contract manufacturing for human over-the-counter drug products 
SPL Implementation Guide with Validation Procedures v1

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produced under a monograph (C170729) or manufactures human over-thecounter drug products produced under a monograph (C131708). 

4.1.5 Business Operation Product 

The following example shows how the business operations are specified for particular 

products. It is done by replicating the business operation (actDefinition) elements, 

and connecting each with one product as shown below: 

<document> 

 <author> 

 <assignedEntity><representedOrganization> <!-- Labeler --> 

 <assignedEntity><assignedOrganization> <!-- Registrant --> 

 <assignedEntity><assignedOrganization/> <!-- Establishment --> 

<performance><actDefinition> 

 <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

 <product><manufacturedProduct classCode=“MANU”><manufacturedMaterialKind> 

 <code code="0123-12345" codeSystem="2.16.840.1.113883.6.69"/> 

 </manufacturedMaterialKind></manufacturedProduct></product> 

</actDefinition></performance> 

<performance><actDefinition> 

 <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

 <product><manufacturedProduct classCode=“MANU”><manufacturedMaterialKind> 

 <code code="0123-12348" codeSystem="2.16.840.1.113883.6.69"/> 

Validation Procedures 

4.1.5.1 If the product is regulated by CDER, then an establishment operation listed is 

linked to at least one listed product or part product, except for Human 

Compounded Drug Label (75031-5).

4.1.5.2 If the product is regulated by CDER, then each listed product having an active 

marketing status is linked from at least one establishment operation, except for 

Human Compounded Drug Label (75031-5).

4.1.5.3 If the product is regulated by CDRH, CFSAN, or CVM or if it is a Human 

Compounded Drug Label (75031-5) or Animal Compounded Drug Label

(77647-6), then there is no operation-product link (NDC product code-toestablishment-business operation data relationship). 

4.1.5.4 If the product is regulated by CBER, then the operation-product link is optional. 

(NDC product code-to-establishment-business-operation data relationship) 

4.1.5.5 An operation product link refers to the product item code of an existing product. 
4 Drug and Biologics Labeling, Listing, and other Product Submission

112

4.2 Body

4.2.1 Required Sections

Validation Procedures

4.2.1.1 The document body contains one or more sections

4.2.1.2 One section contains the product data elements

4.2.1.3 With the exception of inner components of kits or for products with item codes 

(NDC product codes) for which the marketing status code is new or cancelled, 

for each product there is a representative sample image of a carton/container 

label in a major SPL section with section heading Package Label.Principal 

Display Panel (51945-4), except for Positron Emission Tomography drug 

products (files with only one establishment and this establishment having 

business operation Positron Emission Tomography Drug Production, C91403) 

and Non-Standardized Allergenic Label (53405-7), Animal Compounded Drug

Label (77647-6), and Human Compounded Drug Label (75031-5) or if the SPL 

file is for Salvaged Drugs, i.e., having business operation as salvage (C70827).

4.2.1.4 If the document type is Non-Standardized Allergenic Label (53405-7), then 

there is at least one carton/container label in a major SPL section with section 

heading Package Label.Principal Display Panel (51945-4) in the SPL, except if 

there is no marketing status other than new or cancelled.

4.2.1.5 If the document type is Human Prescription Drug Label (34391-3), Prescription 

Animal Drug Label (50578-4), Animal Cells, Tissues, and Cell and Tissue Based 

Product Label (98075-5), or CVM document types other than Recombinant 

Deoxyribonucleic Acid Construct Label (78745-7), or Intentional Animal 

Genomic Alteration Label (101437-2), then there is at least one other content of 

labeling section besides SPL Listing Data Elements Section (48780-1) and 

Package Label.Principal Display Panel (51945-4), except if there is no 

marketing category code other than Bulk Ingredient (C73626), Drug for Further 

Processing (C94795), Unapproved Medical Gas (C73613), Approved Drug 

Product Manufactured under Contract (C132333), OTC Monograph Drug 

Product Manufactured under Contract (C132334), Unapproved Drug Product 

Manufactured under Contract (C132335), Bulk Ingredient for Human 

Prescription Compounding (C96793), Bulk Ingredient for Animal Drug 

Compounding (C98252) or Export Only (C73590), or there is no active 

ingredient other than those in the designated medical gas validation list or there 

is no marketing status other than new or cancelled.

4.2.1.6 If the approval number is in the medication guide validation list and the 

marketing category is not Approved Drug Product Manufactured Under 
SPL Implementation Guide with Validation Procedures v1

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Contract (C132333), then there is such an SPL Medguide Section (42231-1),

except if there is no marketing status other than new or cancelled.

4.2.1.7 If the document type is Human OTC Drug Label (34390-5) and the marketing 

category code is not Approved Drug Product Manufactured under Contract

(C132333), OTC Monograph Drug Product Manufactured under Contract 

(C132334), Unapproved drug Product Manufactured under Contract (C132335) 

Export Only (C73590) or OTC Monograph Drug (C200263) and the citation is 

not sunscreens (part352), then there is an OTC - Active Ingredient Section

(55106-9), except if there is no marketing status other than new or cancelled.

4.2.1.8 If the document type is 34390-5 (Human OTC Drug Label) and the marketing 

category code is not C132333 (Approved Drug Product Manufactured Under 

Contract), C132334 (OTC Monograph Drug Product Manufactured Under 

Contract), C132335 (Unapproved drug Product Manufactured Under Contract) 

or C73590 (Export Only) and the citation is not part352 (sunscreens), then there 

is an OTC – Purpose section (55105-1), except if there is no marketing status 

other than new or cancelled.

4.2.1.9 If the document type is 34390-5 (Human OTC Drug Label) and the marketing 

category code is not C132333 (Approved Drug Product Manufactured Under 

Contract), C132334 (OTC Monograph Drug Product Manufactured Under 

Contract), C132335 (Unapproved Drug Product manufactured Under Contract) 

or C73590 (Export Only) and the citation is not part352 (sunscreens), then there 

is an OTC – keep out of reach of children section (50565-1), except if there is no 

marketing status other than new or cancelled.

4.2.1.10 If the document type is 34390-5 (Human OTC Drug Label) and the marketing 

category code is not C132333 (Approved Drug Product Manufactured Under 

Contract), C132334 (OTC Monograph Drug Product Manufactured Under 

Contract), C132335 (Unapproved Drug Product Manufactured Under Contract) 

or C73590 (Export Only) and the citation is not part352 (sunscreens), then there 

is an Indications & usage section (34067-9), except if there is no marketing 

status other than new or cancelled.

4.2.1.11 If the document type is 34390-5 (Human OTC Drug Label) and the marketing 

category code is not C132333 (Approved Drug Product Manufactured Under 

Contract), C132334 (OTC Monograph Drug Product Manufactured Under 

Contract), C132335 (Unapproved Drug Product Manufactured Under Contract) 

or C73590 (Export Only) and the citation is not part352 (sunscreens), then there 

is a Warnings section (34071-1), except if there is no marketing status other than 

new or cancelled.

4.2.1.12 If the document type is 34390-5 (Human OTC Drug Label) and the marketing 

category code is not C132333 (Approved Drug Product Manufactured Under 

Contract), C132334 (OTC Monograph Drug Product Manufactured Under 

Contract), C132335 (Unapproved Drug Product Manufactured Under Contract) 
4 Drug and Biologics Labeling, Listing, and other Product Submission

114 

or C73590 (Export Only) and the citation is not part352 (sunscreens), then there 

is a Dosage & administration section (34068-7), except if there is no marketing 

status other than new or cancelled. 

4.2.1.13 If the document type is 34390-5 (Human OTC Drug Label) and the marketing 

category code is not C132333 (Approved Drug Product Manufactured Under 

Contract), C132334 (OTC Monograph Drug Product Manufactured Under 

Contract), C132335 (Unapproved Drug Product Manufactured Under Contract) 

or C73590 (Export Only) and the citation is not part352 (sunscreens), then there 

is an Inactive ingredient section (51727-6), except if there is no marketing status 

other than new or cancelled. 

4.2.1.14 If the marketing category is “unapproved drug for use in drug shortage” 

(C101533), then Health Care Provider Letter Section (71744-7) is present, 

except if there is no marketing status other than new or cancelled. 

4.2.1.15 Package Label.Principal Display Panel Section(s) (51945-4) are the last 

section(s) in the document. 

4.2.1.16 If any of the products has the marketing status code is new or cancelled, then 

there may not be a content of labeling section. 

4.2.2 Reporting Period (for certain submissions) 

For certain drug product submission files (currently Human Compounded Drug 

Label), a reporting period is provided as follows: 

<component> 

 <section> 

 <id root="e13a985b-f706-a5c8-e8ef-73891eb1c697"/> 

 <code code="48780-1" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <effectiveTime> 

 <low value="20150601"/> 

 <high value="20151130" closed="false"/> 

 </effectiveTime> 

Validation Procedures 

4.2.2.1 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6), then the product data element section’s 

effective time contains the reporting period.

4.2.2.2 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6), then reporting period (effective time) has 

low and high boundaries for reporting period start and end date respectively. 
SPL Implementation Guide with Validation Procedures v1

115 

4.2.2.3 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6), then reporting start date has at least the 

precision of day in the format YYYYMMDD 

4.2.2.4 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6), then reporting end date has at least the 

precision of day in the format YYYYMMDD 

4.2.2.5 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6), then reporting start date is before reporting 

end date.

4.2.2.6 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6), then reporting period start date (low value) 

is any day of any year between 2014 to current year. 

4.2.2.7 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) and the reporting period start date (low 

value) is December 1, then the end date (high value) is May 31 of the following 

year.

4.2.2.8 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) and the reporting period start date (low 

value) is June 1, then the end date (high value) is November 30 of the same year. 

4.2.2.9 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) and the reporting period start date (low 

value) is not Dec 1 or Jun 1, then the reporting period end date (high value) is 6 

month from the start date.

<section> 

 <id root="..."/> 

 <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <title/> 

 <text> 

 <paragraph>No Products to Report.</paragraph> 

 </text> 

4.2.2.10 If no products are reported in the product data element section of a Human 

Compounded Drug Label (75031-5) or Animal Compounded Drug Label 

(77647-6), i.e., the product data elements section contains no subject element, 

then the product data elements section contains section text with the single 

paragraph “No Products to Report” and the only section is the product data 

elements section.

4.2.2.11 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) and the text section is included in the 
4 Drug and Biologics Labeling, Listing, and other Product Submission

116

product data elements section, then there is no subject element (for the product 

data elements).

4.2.2.12 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) and no products are reported, then the 

facility can not be associated with any compounded drug in this period.

4.2.2.13 If the document type is Human Compounded Drug Label (75031-5) or Animal 

Compounded Drug Label (77647-6) with products reported in this period, then 

the establishment can not be associated with another Human Compounded Drug 

Label that states “No Products to Report” for this period.
SPL Implementation Guide with Validation Procedures v1

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5 NDC/NHRIC Labeler Code Request

5.1 Header

5.1.1 Document type

<document> 

 <code code="51726-8" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="NDC/NHRIC Labeler Code request"/> 

Validation Procedures 

5.1.1.1 Document code is NDC/NHRIC Labeler Code Request (51726-8), NDC Labeler 

Code Request - Animal Drug (72871-7), NDC Labeler Code Inactivation 

(69968-6), or NDC Labeler Code Inactivation – Animal Drug (81204-0).

5.1.1.2 There is no title

5.1.1.3 If a document with the same set id has been previously submitted, then it is an 

NDC/NHRIC Labeler Code Request (51726-8) or NDC Labeler Code Request - 

Animal Drug (72871-7), NDC Labeler Code Inactivation (69968-6), or NDC 

Labeler Code Inactivation – Animal Drug (81204-0).

5.1.1.4 If the document is an NDC Labeler Code Inactivation (69968-6) or NDC 

Labeler Code Inactivation – Animal Drug (81204-0), then an NDC/NHRIC 

Labeler Code Request (51726-8) or NDC Labeler Code Request - Animal Drug 

(72871-7) document with the same set id has been previously submitted 

5.1.1.5 If the document is an NDC Labeler Code Inactivation (69968-6) or NDC 

Labeler Code Inactivation – Animal Drug (81204-0), then there is no labeler 

information. 

5.1.1.6 If the document is an NDC Labeler Code Inactivation (69968-6), or NDC 

Labeler Code Inactivation – Animal Drug (81204-0), then all NDCs with the 

NDC Labeler Code linked to the NDC Labeler Code Inactivation file's set ID is 

associated with a product with a marketing end date, except if the NDC Labeler 

Code Inactivation file was initiated by the FDA.
 5 NDC/NHRIC Labeler Code Request

118 

5.1.2 Labeler information 

<document> 

 <author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <id extension=”0001” root=”2.16.840.1.113883.6.69”/> 

 <name>Mann's drug Store</name> 

 <contactParty> 

Validation Procedures 

5.1.2.1 If the document is an NDC/NHRIC Labeler Code Request (51726-8) or NDC 

Labeler Code Request - Animal Drug (72871-7), then there is a labeler 

organization. 

5.1.2.2 There are two ids (NDC/NHRIC labeler code and DUNS Number) (except for 

an initial labeler code request, which should be submitted with only one id 

(DUNS Number.))

5.1.2.3 One id, the DUNS number, and name are as in Section 2.1.5. 

5.1.2.4 One id has the root 2.16.840.1.113883.6.69 and an extension (except for an 

initial labeler code request, which should be submitted without this id 

(NDC/NHRIC labeler code.))

5.1.2.5 There is no id root besides 1.3.6.1.4.1.519.1 and 2.16.840.1.113883.6.69 

5.1.2.6 If no document with the same set id has been previously submitted, then the 

NDC labeler code has not been associated previously with a different setId 

(regardless of version)

5.1.2.7 The set id is not associated with any other id(NDC/NHRIC labeler code) with 

root 2.16.840.1.113883.6.69 

5.1.2.8 The id extension(NDC/NHRIC labeler code) with the root 

2.16.840.1.113883.6.69 has 4 or 5 digits 

5.1.2.9 The id extension(NDC/NHRIC labeler code) with the root 

2.16.840.1.113883.6.69 with 5 digits does not have a leading zero 

5.1.2.10 The labeler code (id extension with the root 2.16.840.1.113883.6.69) is not 

(0)0000, (0)0001, (0)1500, (0)1800 or (0)1900. 

5.1.2.11 There is one contact party
SPL Implementation Guide with Validation Procedures v1

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5.1.2.12 If a document with the same set id has previously been submitted, then there is a 

labeler code (id with the root 2.16.840.1.113883.6.69) same as the one 

previously submitted under that set id (if any). 

5.1.3 Labeler Detail Information 

To describe details of a labeler such as physical address, US agent, and business 

operations the following structure is added 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <id extension=”0001” root=”2.16.840.1.113883.6.69”/> 

 <name>Mann's drug Store</name> 

 <contactParty>...</contactParty> 

 <assignedEntity> 

 <assignedOrganization> 

 <assignedEntity><!-- Labeler Details --> 

 <assignedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <name>Mann's drug Store</name> 

 <addr>...</addr> 

The format is similar to the Establishment description. The only difference is that 

there is only one such “Establishment” with the same DUNS number and name as the 

Labeler.

Validation Procedures 

5.1.3.1 If the document is not a NDC/NHRIC Labeler Code Request (51726-8), then 

there is no labeler detail information.

5.1.3.2 Labeler detail information has no registrant information and exactly one 

“Establishment”

5.1.3.3 Labeler detail information has exactly one “Establishment”

5.1.3.4 There is one id. 

5.1.3.5 Id (DUNS Number) has the root 1.3.6.1.4.1.519.1 

5.1.3.6 Id (DUNS Number) is the same as the id of the labeler organization. 

5.1.3.7 Name is the same as the name of the labeler organization.

5.1.3.8 Labeler detail information has an address as in Section 2.1.6. 
 5 NDC/NHRIC Labeler Code Request

120 

5.1.3.9 There are no further elements besides the id, name, addr, and Labeler US Agent 

on this level. 

5.1.3.10 The DUNS number along with the labeler details’ name and address information 

match the DUNS number record in the Dun and Bradstreet database. 

5.1.4 Labeler US Agent 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <id extension="0001" root=”2.16.840.1.113883.6.69”/> 

 <name>Mann's drug Store</name> 

 <contactParty>...</contactParty> 

 <assignedEntity> 

 <assignedOrganization> 

 <assignedEntity> 

 <assignedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <assignedEntity> 

 <assignedOrganization> <!-- labeler US agent --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <name>Simmons Reps Company</name> 

 <telecom value="tel:+1-800-555-1212"/> 

 <telecom value="mailto:contact@USagent.com"/> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C73330" displayName="United States agent" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

Validation Procedures 

5.1.4.1 If the country for the labeler is not “USA”, then there may be one US agent 

5.1.4.2 US agent is as defined in Section 6.1.3.114 

5.1.5 Labeler Operation 

To describe the activity of a labeler with business operations the following structure 

is added. 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <id extension="0001" root=”2.16.840.1.113883.6.69”/> 

 <name>Mann's drug Store</name> 

 <contactParty>...</contactParty> 
SPL Implementation Guide with Validation Procedures v1

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 <assignedEntity> 

 <assignedOrganization> 

 <assignedEntity> 

 <assignedOrganization> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C43360" displayName="manufacture" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <subjectOf> 

 <approval> 

 <code code="C106643" displayName="Manufactures human 

prescription drug products" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </approval> 

 </subjectOf> 

 </actDefinition> 

Validation Procedures 

5.1.5.1 There are one or more labeler operation details (performance act definitions).

5.1.5.2 Each performance act definition (business operation) has one code.

5.1.5.3 Code system is 2.16.840.1.113883.3.26.1.1 

5.1.5.4 Display name matches the code

5.1.5.5 The code comes from the business operations list except for import (C73599) 

and united states agent (C73330). 

5.1.5.6 Each business operation code is mentioned only once. 

5.1.5.7 There is one or more business operation qualifier except when business 

operation is analysis (C25391), API manufacture (C82401) , or SIP Foreign 

Seller (C175317). 

5.1.5.8 Business operation qualifier has one code. 

5.1.5.9 Code system is 2.16.840.1.113883.3.26.1.1 

5.1.5.10 Display name matches the code 

5.1.5.11 If the business operation is manufacture (C43360), then the business operation 

qualifier is Manufactures human prescription drug products (C106643), 

Manufactures human over-the-counter drug products not produced under an 

approved drug application or under a monograph (C131710), Manufactures 

human over-the-counter drug products produced under a monograph

(C131708), Manufactures human over-the-counter drug products produced 

under an approved drug application (C131709), and/or Contract manufacturing 
 5 NDC/NHRIC Labeler Code Request

122 

for human over-the-counter drug products produced under a monograph

(C170729). 

5.1.5.12 If the business operation is distributes drug products under own private label

(C73608), then the business operation qualifier is distributes human prescription 

drug products (C111077) and/or distributes human over-the-counter drug 

products (C111078.) 

5.1.5.13 If the qualifiers Intent to compound 506e (drug shortage) drugs (C112087), No 

intent to compound 506e (drug shortage) drugs (C112091), Compounding from 

bulk ingredients (C112092), Not compounding from bulk ingredients 

(C112093), Compounding sterile products (C112094), or Not compounding 

sterile products (C112095), then the operation is Human drug compounding 

outsourcing facility (C112113). 

5.1.5.14 If the business operation qualifier is Distributes Human Prescription Drug 

Products (C111077) and/or Distributes Human Over-the-Counter Drug 

Products (C111078), then the business operation is Distributes Drug Products 

under Own Private Label (C73608). 

5.1.6 FDA-Initiated Labeler Code Inactivation 

<document> 

 <legalAuthenticator> 

 <assignedEntity> 

 <representedOrganization> 

5.1.6.1 If the document is an FDA-initiated NDC Labeler Code Inactivation (69968-6), 

FDA-Initiated NDC Labeler Code Inactivation – Animal Drug (81204-0) or an 

FDA-Initiated NDC Labeler Code Re-Activation, then the proper 

legalAuthenticator element is included.

5.1.6.2 One id is a DUNS number with the root 1.3.6.1.4.1.519.1 

5.1.6.3 The id with the root 1.3.6.1.4.1.519.1 (DUNS number) has a 9-digit extension

5.1.6.4 The proper FDA id is provided. 

5.1.6.5 The proper FDA name is provided. 

5.1.6.6 If the most recent document of this setId was an FDA-Initiated NDC Labeler 

Code Inactivation (69968-6) or NDC Labeler Code Inactivation – Animal Drug

(81204-0), then an FDA-Initiated NDC/NHRIC Labeler Code Request (51726-8) 

SPL file with <legalAuthenticator> element has been submitted before an 

NDC/NHRIC Labeler Code Request (51726-8), NDC Labeler Code Request - 

Animal Drug (72871-7), NDC Labeler Code Inactivation (69968-6), or NDC 

Labeler Code Inactivation – Animal Drug (81204-0) can be submitted by the 

labeler.
SPL Implementation Guide with Validation Procedures v1

123 

5.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 

5.2.1.1 The document body is empty 
6 Establishment registration

124 

6 Establishment registration

Establishment registrations have only header information with a single registrant 

organization and one or more registered establishments. Aside from the proper 

Establishment Registration document type, two other document types can be used for 

establishment registration submissions, i.e., the No Change Notification, the 

Establishment Deregistration and Out of Business Notification. 

6.1 Header

6.1.1 Document type 

<document> 

 <code code="51725-0" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="Establishment registration"/> 

Validation Procedures 

6.1.1.1 Document type is “Establishment registration” (51725-0), “Establishment DeRegistration” (70097-1), “No change notification” (53410-7), or “Out of 

Business Notification” (53411-5).

6.1.1.2 The effective time year matches the current year.

6.1.1.3 There is no title

6.1.1.4 For a No change notification (53410-7), or Establishment De-Registration 

(70097-1) the set id in this document should be the same set id included in a 

previously submitted Establishment Registration (51725-0), No change 

notification (53410-7), or Establishment De-Registration (70097-1), with 

information about your establishment(s). 

6.1.1.5 If a document with the same set id as the one in this file has been previously 

submitted, then the document type of the previously submitted file is 

Establishment Registration (51725-0), Establishment De-Registration (70097-1), 

or No change notification (53410-7).

6.1.1.6 “No change notification (53410-7)” documents are submitted during the time 

frame October 1st through December 31st of each year. 

6.1.1.7 If the document type is No Change Notification (53410-7), then its most recent 

Establishment Registration document is not inactivated by an FDA Agency 

Initiated Compliance Action. 
SPL Implementation Guide with Validation Procedures v1

125 

6.1.1.8 If the document type is No Change Notification (53410-7) and its most recent 

Establishment Registration does not have any business operation qualifiers (see 

Section 6.1.7), then a full Establishment Registration file must be submitted 

instead, except if all the business operations are only analysis (C25391), API 

manufacture (C82401), or medicated animal feed manufacture (C84635). 

6.1.1.9 If the document type is No Change Notification (53410-7) and its most recent 

Establishment Registration asserts the business operation qualifier Manufactures 

human over-the-counter drug products (C106645), then the Establishment 

Registration must be updated by submitting a full Establishment Registration 

file.

6.1.1.10 If the document type is No Change Notification (53410-7) and its most recent 

Establishment Registration does not have a second id with the root 

2.16.840.1.113883.4.82 (FEI number) for each establishment, then the 

Establishment Registration must be updated by submitting a full Establishment 

Registration file with FEI numbers. 

6.1.2 Registrant information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

<assignedOrganization> <!-- registrant --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

 <contactParty> 

Validation Procedures 

6.1.2.1 If the document type is “No change notification” or “Establishment DeRegistration”, then there is no registrant information.

6.1.2.2 If the document type is “Establishment registration”, then there is registrant 

information. 

6.1.2.3 There is one id, the DUNS number and name are as in Section 2.1.5. 

6.1.2.4 The id (registrant’s DUNS Number) is not associated with any other set id of 

document type “Establishment registration”, except if the other set id, which 

was included in a previously submitted Establishment Registration SPL file, is 

referred in the related document (RPLC).

6.1.2.5 The set id is not associated with any other registrant id (DUNS Number). 

6.1.2.6 There is one contact party as in section 2.1.8. 
6 Establishment registration

126 

6.1.2.7 Establishment registration has no labeler information (no validation rules 

defined for it).

6.1.3 Establishment Information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- labeler, pass-through --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

<assignedOrganization> <!-- establishment --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <id extension="123456" root=“2.16.840.1.113883.4.82”/> 

 <name>Middleton Manufacturing company</name> 

<addr> 

 <streetAddressLine>123 Burl Road</streetAddressLine> 

 <city>Dublin</city> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

 <contactParty> 

Validation Procedures 

6.1.3.1 If the document type is “establishment registration”, then there are one or more 

establishments.

6.1.3.2 If the document type is No change notification (53410-7) or Establishment DeRegistration (70097-1), then there is no establishment information. 

6.1.3.3 Establishment has one or two id elements, one id, the DUNS number, and name 

are as in Section 2.1.5. 

6.1.3.4 Establishment’s DUNS number is not associated with another establishment in 

the same SPL file.

6.1.3.5 Establishment’s DUNS number is not associated with any other set id for 

document type “Establishment registration”, except if the other set id, which 

was included in a previously submitted Establishment Registration SPL file, is 

referred in the relatedDocument (RPLC, see Section 2.1.11 Predecessor 

Document for more details).

6.1.3.6 The DUNS number along with the establishment name and address information 

match the DUNS number record in the Dun and Bradstreet database, except if 

all establishments have only the business operations Medicated Animal Feed 

Manufacture (C84635). 
SPL Implementation Guide with Validation Procedures v1

127 

6.1.3.7 If there is a second id, then its root is 2.16.840.1.113883.4.82 and the extension 

(FEI number) is 7 or 10 digits 

6.1.3.8 Each establishment has an address as in Section 2.1.6. 

6.1.3.9 There is one contact party as in Section 2.1.8. 

6.1.3.10 There is no assigned entity other than for US Agent or Import business. 

6.1.3.11 If the document type is Establishment Registration (51725-0) and there is a 

previously submitted document with the same set id as the one in this file where 

this establishment had already been mentioned, then there is a second id with the 

root 2.16.840.1.113883.4.82 (FEI number) for each establishment previously 

identified by an id (DUNS number) with the root 1.3.6.1.4.1.519.1. 

6.1.4 Establishment US agent 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

<assignedOrganization> <!-- establishment --> 

 <addr> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

 <assignedEntity> 

 <assignedOrganization> <!-- establishment US agent --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <name>Simmons Reps Company</name> 

 <telecom value="tel:+1-800-555-1212"/> 

 <telecom value="mailto:contact@USagent.com"/> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C73330" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="United States agent"/> 

Validation Procedures 

6.1.4.1 If the country for the establishment is not “USA”, then there is one US agent 

6.1.4.2 US agent element has code, code system and display name are as above

6.1.4.3 If the country for the establishment is “USA”, then there is no US agent 

6.1.4.4 US agent has one id, (the DUNS number), and name are as in Section 2.1.5. 
6 Establishment registration

128 

6.1.4.5 US agent has a US telephone number and an email address.

6.1.4.6 The US agent’s DUNS number matches the DUNS number record in the Dun 

and Bradstreet database and is for a USA location. 

6.1.4.7 There is at most one US Agent. 

6.1.5 Import business 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

 <assignedOrganization> 

 <assignedEntity> <!-- registrant --> 

<assignedOrganization> <!-- establishment --> 

 <addr> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

<assignedEntity> 

 <assignedOrganization> <!-- establishment’s importer --> 

 <id extension="100000005" root="1.3.6.1.4.1.519.1"/> 

 <name>Waytogo importers</name> 

 <telecom value="tel:+1-800-555-1214"/> 

 <telecom value="mailto:contact@waytogo.com"/> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C73599" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="import"/> 

Validation Procedures 

6.1.5.1 If the country code for the establishment is not “USA”, then there may be one or 

more import businesses. 

6.1.5.2 Each business has code, code system and display name are as above.

6.1.5.3 If the country code for the establishment is USA, then there are no import 

businesses 

6.1.5.4 Importer has one id, the DUNS number and name are as in Section 2.1.5. 

6.1.5.5 Importer has a US telephone number and email address.
SPL Implementation Guide with Validation Procedures v1

129 

6.1.6 Establishment operation 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

<assignedEntity> 

 <assignedOrganization> 

 <!-- establishment --> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

Validation Procedures 

6.1.6.1 There are one or more establishment operation details (performance act 

definitions). 

6.1.6.2 Each performance act definition has one code. 

6.1.6.3 Code system is 2.16.840.1.113883.3.26.1.1 

6.1.6.4 Display name matches the code 

6.1.6.5 The code comes from the business operations list except for import (C73599), 

united states agent (C73330), distributes drug products under own private label

(C73608), API/FDF analytical testing (C101509), clinical bioequivalence or 

bioavailability study (C101511), FDF manufacture (C101510), in vitro 

bioequivalence or bioanalytical testing (C101512), wholesale drug distributor

(C118411), and third-party logistics provider (C118412). 

6.1.6.6 Each business operation code is mentioned only once per establishment. 

6.1.6.7 There is no product reference.

6.1.6.8 If the business operation is Transfill (C125710), then the business operation 

qualifier is Transfills Medical Gas (C126091). 
6 Establishment registration

130 

6.1.7 Business Operation Qualifier 

<performance> 

 <actDefinition> 

 ... 

 <subjectOf> 

 <approval> 

 <code code="Qualifier Code" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="Qualifier Display Name"/> 

 </approval> 

 </subjectOf> 

Validation Procedures 

6.1.7.1 There are one or more Business Operation Qualifiers, except if the business 

operation is analysis (C25391), API manufacture (C82401), medicated animal 

feed manufacture (C84635) , or SIP Foreign Seller (C175317). 

6.1.7.2 Business operation qualifier has one code. 

6.1.7.3 Code system is 2.16.840.1.113883.3.26.1.1 

6.1.7.4 Code is from the Business Operation Qualifier List 

6.1.7.5 Display name matches the code 

Human Drug Compounding Outsourcing Facility Operation Qualifiers 

6.1.7.6 If the business operation is Human drug compounding outsourcing facility 

(C112113), then there are 2 or 3 operation qualifiers. 

6.1.7.7 One of the qualifiers is Intent to compound 506e (drug shortage) drugs

(C112087) or No intent to compound 506e (drug shortage) drugs (C112091). 

6.1.7.8 Qualifiers Intent to compound 506e (drug shortage) drugs (C112087) and No 

intent to compound 506e (drug shortage) drugs (C112091), both should not be 

present at a time.

6.1.7.9 One of the qualifiers is Compounding from bulk ingredients (C112092) or Not 

compounding from bulk ingredients (C112093). 

6.1.7.10 If one of the business operation qualifiers is compounding from bulk ingredients

(C112092), then one of the following business operation qualifiers should be 

included: Compounding sterile products (C112094), and Not compounding 

sterile products (C112095). 

6.1.7.11 If one of the business operation qualifiers is Not compounding from bulk 

ingredients (C112093), then the following business operation qualifiers should 
SPL Implementation Guide with Validation Procedures v1

131 

not be included: Compounding sterile products (C112094), and Not 

compounding sterile products (C112095). 

6.1.7.12 If the qualifiers Intent to compound 506e (drug shortage) drugs (C112087), No 

intent to compound 506e (drug shortage) drugs (C112091), Compounding from 

bulk ingredients (C112092), Not compounding from bulk ingredients 

(C112093), Compounding sterile products (C112094), or Not compounding 

sterile products (C112095), then the operation is Human drug compounding 

outsourcing facility (C112113). 

Over-the-Counter Drug Operation Qualifiers 

6.1.7.13 Instead of the business operation qualifier Manufactures human over-thecounter drug products (C106645), either Manufactures human over-the-counter 

drug products produced under an approved drug application (C131709), 

Manufactures human over-the-counter drug products not produced under an 

approved drug application or under a monograph (C131710), Manufactures 

human over-the-counter drug products produced under a monograph

(C131708), or Contract manufacturing for human over-the-counter drug 

products produced under a monograph (C170729) must be used. 

6.1.7.14 If the business operation qualifier is Contract manufacturing for human overthe-counter drug products produced under a monograph (C170729) or 

manufactures human over-the-counter drug products produced under a 

monograph (C131708), then the business operation is label (C84732), 

manufacture (C43360), pack (C84731), relabel (C73607), or repack(C73606). 

6.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 

6.2.1.1 The document body is empty 
7 Out of Business Notification

132 

7 Out of Business Notification

The Out of Business Notification allows de-listing of all the establishments of an 

Establishment registration.

7.1 Header

7.1.1 Document type 

<document> 

 <code code="53411-5" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="Out of business notification"/> 

Validation Procedures 

7.1.1.1 Document type is “Out of business notification” (53411-5) 

7.1.1.2 The effective time year matches the current year.

7.1.1.3 There is no title

7.1.1.4 An Establishment Registration (51725-0), Establishment De-Registration 

(70097-1), No change notification (53410-7), Identification of CBER-regulated 

generic drug facility (72090-4), Wholesale Drug Distributors and Third-Party 

Logistics Facility Report (75030-7), or Withdrawal of Wholesale Drug 

Distributors and Third-Party Logistics Facility Report (77573-4) with the same 

set id has been previously submitted. 

7.1.1.5 If a document with the same set id has been previously submitted, then it is an 

Establishment Registration (51725-0), Establishment De-Registration (70097-1), 

No change notification (53410-7), Identification of CBER-regulated generic 

drug facility (72090-4), Wholesale Drug Distributors and Third-Party Logistics 

Facility Report (75030-7), or Withdrawal of Wholesale Drug Distributors and 

Third-Party Logistics Facility Report (77573-4).

7.1.1.6 There is no labeler, registrant, or establishment information. 

7.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 
SPL Implementation Guide with Validation Procedures v1

133 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 

7.2.1.1 The document body is empty 
8 Pharmacologic Class Indexing

134 

8 Pharmacologic Class Indexing

8.1 Header

8.1.1 Document type 

<document> 

 <code code="60685-5" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Indexing - Pharmacologic Class"/> 

Validation Procedures 

8.1.1.1 Document code is as above 

8.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type.

8.1.2 Author information 

Pharmacologic class indexing is maintained by FDA:

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

Pharmacologic classes for Mechanism of Action (MoA), Physiologic Effect (PE), 

Established Pharmaceutical Class (EPC) and some estensions (EXT) and their 

hierarchy are maintained by the U.S. Department of Veterans Affairs’s MED-RT

system: 

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="926891516"/> 

 <name>Department of Veterans Affairs</name> 

Chemical structure classes and their hierarchy are maintained in the National Library 

of Medicine’s (NLM) Medical Subject Heading (MeSH) system:

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="015333032"/> 

 <name>National Library of Medicine</name> 

8.1.2.1 Author information for pharmacologic class indexing is as one of the above 
SPL Implementation Guide with Validation Procedures v1

135 

8.2 Body

<section> 

 <id root="ffabedf9-6bde-4787-beb0-abd214307427"/> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL Indexing Data Elements Section"/> 

 <title/> 

 <text/> 

 <effectiveTime value="20101007"/> 

 <subject> 

Validation Procedures 

8.2.1 Pharmacologic Class Indexing Section 

8.2.1.1 If the document type is Indexing – Pharmacologic Class (60685-5), then the 

document contains one SPL Indexing Data Elements Section (48779-3) as 

above. 

8.2.1.2 Value of effective time is same as value of effective time in document 

information. 

8.2.2 Pharmacologic Class Indexing 

<section> 

 <subject> 

<identifiedSubstance> 

 <id root="0987654321" extension="2.16.840.1.113883.4.9"/> 

 <identifiedSubstance> 

 <code code="0987654321" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>tazminic acid</name> 

 <asSpecializedKind> 

8.2.2.1 There is one active moiety.

8.2.2.2 There is one active moiety code.

8.2.2.3 Code system is 2.16.840.1.113883.4.9 

8.2.2.4 Code and code system are the same as the parent element id’s extension and root 

respectively.

8.2.2.5 There is one active moiety name

8.2.2.6 Active moiety name matches code

8.2.2.7 The same active moiety is not described in a pharmacologic class indexing 

document with a different set id.

8.2.2.8 There is no document with the same set id but a different active moiety. 
8 Pharmacologic Class Indexing

136 

8.2.2.9 There are one or more pharmacologic class components

<asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="N0000012345" codeSystem="2.16.840.1.113883.6.345" 

 displayName="melhoridizing tazminate [EPC]"/> 

 <name>melhoridizing tazminate (MTZ)</name> 

8.2.2.10 Under each pharmacologic class component, there is a code 

8.2.2.11 Code system is 2.16.840.1.113883.6.345 (MED-RT) or 2.16.840.1.113883.6.177 

(MeSH)

8.2.2.12 If code system is MED-RT, then the code starts with a uppercase “N”, followed 

by 10 digits 

8.2.2.13 If code system is MeSH, then the code starts with a uppercase “M”, followed by 

7 or more digits

8.2.2.14 There is one display name 

8.2.2.15 If the code system is MED-RT (2.16.840.1.113883.6.345), then display name is 

the formal MED-RT name with the bracket indicating the kind of concept [EPC, 

MoA, PE, EXT] 

8.2.2.16 If the code system is MeSH (2.16.840.1.113883.6.177), then display name is the 

preferred MeSH name with a bracket “[CS]” indicating the kind of concept 

being “Chemical Structure”.

8.2.2.17 If the concept is an External Pharmacologic Class [EPC], there is a name with 

the preferred FDA name.

8.2.3 Pharmacologic Class Definition 

<section> 

 <subject> 

<identifiedSubstance> 

 <id root="N0000012345" extension="2.16.840.1.113883.6.345"/> 

 <identifiedSubstance> 

 <code code="N0000012345" codeSystem="2.16.840.1.113883.6.345" 

 displayName="melhoridizing tazminate [EPC]"/> 

 <name use="L">melhoridizing tazminate (MTZ)</name> 

 <name use="A">melhoridizing tazminate [EPC]</name> 

 <name use="A">tazminic melhoridizer</name> 

 <asSpecializedKind> 

8.2.3.1 There are one or more pharmacologic classes.

8.2.3.2 There is one code.
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8.2.3.3 The rules for the pharmacologic class code, code system and display name are as 

in the respective procedures 8.2.2.12 and following.

8.2.3.4 Code and code system are the same as the parent element id’s extension and root 

respectively.

8.2.3.5 There are one or more names

8.2.3.6 One name has the use attribute “L” indicating the preferred name.

8.2.3.7 If the concept is not an Established Pharmacologic Class [EPC], then the name 

with the use attribute “L” is the same as the displayName.

8.2.3.8 There are zero, one or more defining super-classes

<asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="N0000012345" codeSystem="2.16.840.1.113883.6.345" 

 displayName="melhoridizing tazminate [EPC]"/> 

8.2.3.9 Under each defining super-class there is a code

8.2.3.10 The rules for the defining super-class code, code system and displayName are as 

in the respective procedures 8.2.2.12ff

8.2.3.11 There is no other name element. 
9 Dietary Supplement Labeling

138 

9 Dietary Supplement Labeling

Dietary supplement labeling provides a description of the product. 

9.1 Header

9.1.1 Document Type 

9.1.1.1 Document types for dietary supplement labeling is 58476-3 FDA product label 

Dietary supplement. 

9.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type.

9.1.1.3 If the document type changes from Human Prescription Drug Label (34391-3) 

or Human OTC Drug Label (34390-5) to Dietary Supplement (58476-3), then 

submit a new listing file with new NDC codes for the Dietary Supplement. 

9.1.1.4 The set id is not associated with any top level product with a different Labeler 

Prefix

9.1.2 Labeler information 

<document> 

 <code code="58476-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Dietary Supplement"/> 

<author> 

<assignedEntity> 

 <representedOrganization> 

 <id extension="100000007" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

Validation Procedures 

9.1.2.1 There is one labeler

9.1.2.2 There is one id, the DUNS number, and name is as in Section 2.1.5. 

9.1.2.3 There is no other element besides id, name and registrant.

9.1.3 Registrant information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

<assignedEntity> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 
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 <assignedOrganization> 

 <id extension="100000008" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

Validation Procedures 

9.1.3.1 There may be registrant information

9.1.3.2 If there is a registrant, then there is one id, (the DUNS number) and a name as in 

Section 2.1.5. 

9.1.3.3 There is no other element besides id, name and establishments. 

9.2 Body

9.2.1 Required Sections

Validation Procedures 

9.2.1.1 The document body contains three or more sections 

9.2.1.2 One section contains the product data elements 

9.2.1.3 There is a Package Label.Principal Display Panel Section (51945-4) with an 

image of the carton/container label including the Supplement Facts.

9.2.1.4 There is one Statement of Identity Section (69718-5). 

9.2.1.5 Aside from SPL Listing Data Elements Section (48780-1), Package 

Label.Principal Display Panel (51945-4) and Statement of Identity Section 

(69718-5), there are only the Health Claim Section (69719-3), the Warnings 

Section (34071-1) for the warning statement, the Precautions Section (42232-9) 

for the notice statement, the Safe Handling Warning Section (50741-8) for the 

safe handling statement, and the Dosage & Administration Section (34068-7).
10 Medical Food Labeling

140 

10 Medical Food Labeling

Medical Food labeling provides a description of the product. 

10.1 Header

10.1.1 Document Type 

10.1.1.1 Document types for Medical Food labeling is 58475-5 FDA product label 

Medical Food. 

10.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type. 

10.1.2 Labeler information 

<document> 

 <code code="58475-5" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Medical Food"/> 

<author> 

<assignedEntity> 

 <representedOrganization> 

 <id extension="100000007" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

Validation Procedures 

10.1.2.1 There is one labeler

10.1.2.2 There is one id, the DUNS number, and name is as in Section 2.1.5. 

10.1.2.3 The set id is not associated with any top level product with a different Labeler 

Prefix

10.1.2.4 There is no other element besides id, name and registrant. 

10.1.3 Registrant information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

<assignedEntity> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

 <assignedOrganization> 

 <id extension="100000008" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 
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Validation Procedures 

10.1.3.1 There may be registrant information

10.1.3.2 If there is a registrant, then there is one id, (the DUNS number) and a name as in 

Section 2.1.5. 

10.1.3.3 There is no other element besides id, name and establishments. 

10.1.4 Establishment information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> <!-- Labeler --> 

 <assignedEntity> 

 <assignedOrganization> <!-- Registrant --> 

<assignedEntity> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

 <assignedOrganization> <!-- Establishment --> 

 <id extension="1000000019" root="1.3.6.1.4.1.519.1"/> 

 <name>Middleton Manufacturing company</name> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C43360" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

Validation Procedures 

10.1.4.1 If the marketing status code for any of the products is not completed, then there 

are one or more establishments.

10.1.4.2 There is one id (the DUNS number) and name is as in Section 2.1.5. 

10.1.4.3 id is not used for other establishments in the file 

10.1.4.4 Establishment (“assignedOrganization”) has no other element besides id and 

name.

10.1.4.5 The establishment id (DUNS Number) has been submitted in a document of type 

“Establishment Registration” (51725-0) on or after October 1st of the previous 

year, or, if earlier, that Establishment Registration has been followed by a 

document of type “No Change Notification” (53410-7) between October 1st and 

December 31st of the previous or the current year. 

10.1.4.6 There are one or more business operations. 

10.1.4.7 Act definition display name matches code
10 Medical Food Labeling

142

10.1.4.8 The code comes from the business operations list except for import (C73599), 

united states agent (C73330) and distributes drug products under own private 

label (C73608) 

10.1.4.9 Business operation code matches a business operation code for the establishment 

with same id in its most recent establishment registration

10.2 Body

10.2.1 Required Sections

Validation Procedures

10.2.1.1 The document body contains two or more sections

10.2.1.2 One section contains the product data elements

10.2.1.3 There is a Package Label.Principal Display Panel (51945-4) Section with an 

image of the carton/container label.
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11 Medical Device Labeling

11.1 Header

11.1.1 Document Type 

11.1.1.1 Document types are OTC Medical Device Label (69403-4) or Prescription 

Medical Device Label (69404-2). 

11.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type. 

11.1.2 Labeler information 

<document> 

 <code code="..." codeSystem="2.16.840.1.113883.6.1" 

 displayName="..."/> 

<author> 

<assignedEntity> 

 <representedOrganization> 

 <id extension="100000007" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme drug company</name> 

 <contactParty> 

 <addr> 

 <streetAddressLine>1625 29th street</streetAddressLine> 

 <city>Camden</city> 

 <state>NJ</state> <postalCode>08101</postalCode> 

 <country code="USA" codeSystem="1.0.3166.1.2.3">USA</country> 

 </addr> 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

 <contactPerson> 

 <name>Bob Jones</name> 

 </contactPerson> 

 </contactParty> 

Validation Procedures 

11.1.2.1 There is one labeler

11.1.2.2 There is one DUNS number and name. 

11.1.2.3 There are no other elements. 
11 Medical Device Labeling

144

11.2 Body

11.2.1 Required Sections

Validation Procedures

11.2.1.1 The document body contains three or more sections

11.2.1.2 One section contains the product data elements

11.2.1.3 There is a Package Label.Principal Display Panel (51945-4) section with an 

image of the carton/container label.
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12 Billing Unit Indexing

This document links the NDC for a marketed drug product with the National Council 

for Prescription Drug Programs (NCPDP) standard billing unit. 

12.1 Header

12.1.1 Document Type 

<document ...> 

 <code code="71446-9" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Indexing - Billing Unit" /> 

Validation Procedures 

12.1.1.1 The code for the document type is Indexing - Billing Unit (71446-9) 

12.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type

12.1.2 Author 

<author> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="021660014"/> 

 <name>National Council for Prescription Drug Programs</name> 

Validation Procedures 

12.1.2.1 The author is the “National Council for Prescription Drug Programs” 

12.1.2.2 The DUNS Number for the author is 021660014 

12.1.2.3 There are no other author elements than id and name. 

12.2 Body

12.2.1 Indexing Section 

<section> 

 <id root="ffabedf9-6bde-4787-beb0-abd214307427"/> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL indexing data elements section" /> 

 <title/> 

 <text/> 

 <effectiveTime value="20121007"/> 

 <subject> 
12 Billing Unit Indexing

146 

Validation Procedures 

12.2.1.1 If the document type is Indexing – Billing Unit (71446-9), then the document 

contains one SPL Indexing Data Elements section as above. 

12.2.1.2 Value of effective time is same as value of effective time in document 

information. 

12.2.2 NDC 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <asContent> 

 <containerPackagedProduct> 

 <code code="NDC Package Code" 

 codeSystem="2.16.840.1.113883.6.69"/> 

Validation Procedures 

12.2.2.1 There is an NDC package code inside an otherwise empty container element 

inside an otherwise empty manufactured product element. 

12.2.2.2 NDC contains three segments divided by hyphens 

12.2.2.3 Code system for NDC is 2.16.840.1.113883.6.69 

12.2.2.4 The NDC matches an NDC contained in a listing / labeling document previously 

submitted.

12.2.2.5 The NDC is not associated with another set id with the document type Indexing 

- Billing Unit

12.2.3 Billing Unit 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <asContent> 

 <containerPackagedProduct> 

 <code code="NDC Package Code" 

 codeSystem="2.16.840.1.113883.6.69"/> 

 </containerPackagedProduct> 

 <subjectOf> 

 <characteristic> 

 <code code="NCPDPBILLINGUNIT" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="CV" 

 code="Billing Unit Code" 

 codeSystem="2.16.840.1.113883.2.13" xsi:type="CE"/> 
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Validation Procedures

12.2.3.1 There is one billing unit code value

12.2.3.2 Billing unit value is “GM”, “ML” or “EA”

12.2.3.3 Code system for billing unit is 2.16.840.1.113883.2.13

12.2.3.4 There are no other package data elements

12.2.3.5 There are no other product data elements.
13 Generic User Fee Facility Self-Identification

148 

13 Generic User Fee Facility Self-Identification 

Generic user fee facility self-identification has only header information with a single 

registrant organization and one or more self-identified facilitys.

13.1 Header

13.1.1 Document type 

<document> 

 <code code="72090-4" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Identification of CBER-regulated generic drug facility"/> 

Validation Procedures 

13.1.1.1 Document type is “Identification of CBER-regulated generic drug facility” 

(72090-4) or “Generic Drug Facility Identification Submission” (71743-9).

13.1.1.2 The effective time year matches the current year.

13.1.1.3 There is no title

13.1.1.4 If a document with the same set id has been previously submitted, then it is of 

the same type.

13.1.1.5 Documents of type “Generic Drug Facility Identification Submission” (71743-9) 

are not submitted via the OC submission folder or the listed errors below need 

be corrected. (Contact CDEReFacility@fda.hhs.gov for any questions.) 

13.1.2 Registrant information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 
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<assignedOrganization> <!-- registrant --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <name>Green Clover Fine Drugs</name> 

 <contactParty> 

 <addr> 

 <streetAddressLine>1625 29th street</streetAddressLine> 

 <city>Dublin</city> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

 <telecom value="tel:+353-12-551213"/> 

 <telecom value="mailto:jmcfadden@greenclover.com"/> 

 <telecom value="fax:+353-12-551214"/> 

 <contactPerson> 

 <name>Julie McFadden</name> 

 </contactPerson> 

 </contactParty> 

Validation Procedures 

13.1.2.1 There is registrant information.

13.1.2.2 There is one id, the DUNS number and name are as in Section 2.1.5. 

13.1.2.3 id (document id) is not associated with any other set id of the same document 

type.

13.1.2.4 set id is not associated with any other registrant id of the same document type. 

13.1.2.5 There is one contact party as in 2.1.8. 

13.1.2.6 GDUFA facility identification submission has no labeler information. 

13.1.3 Facility Information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

<assignedOrganization> <!-- facility --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <id extension="123456" root=“2.16.840.1.113883.4.82”/> 

 <name>Middleton Manufacturing company</name> 

<addr> 

 <streetAddressLine>123 Burl Road</streetAddressLine> 

 <city>Dublin</city> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 
13 Generic User Fee Facility Self-Identification

150 

 <contactParty> 

 <addr> 

 <streetAddressLine>1625 29th street</streetAddressLine> 

 <city>Dublin</city> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

 <telecom value="tel:+353-12-551213"/> 

 <telecom value="mailto:pmcdonald@middletown.com"/> 

 <telecom value="fax:+353-12-551214"/> 

 <contactPerson> 

 <name>Patrick McDonald</name> 

 </contactPerson> 

 </contactParty> 

Validation Procedures 

13.1.3.1 There are one or more facilities:

13.1.3.2 Facilities have two id elements, one id, the DUNS number, and name are as in 

Section 2.1.5. 

13.1.3.3 DUNS number is not associated with another facility in the same SPL file.

13.1.3.4 DUNS number is not associated with any other set id of the same document 

type.

13.1.3.5 The DUNS number along with the facility name and address information match 

the DUNS number record in the Dun and Bradstreet database 

13.1.3.6 There is a second id, the FEI with root 2.16.840.1.113883.4.82 and 7 or 10 digit 

extension. 

13.1.3.7 Each facility has an address as in Section 2.1.6. 

13.1.3.8 There is one contact party as in Section 2.1.8. 

13.1.3.9 There is no further assigned entity.

13.1.4 Facility operation 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

<assignedEntity> 

 <assignedOrganization> 

 <!-- facility --> 

 </assignedOrganization> 
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 <performance> 

 <actDefinition> 

 <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

Validation Procedures 

13.1.4.1 There are one or more facility operation details (performance act definitions).

13.1.4.2 Each performance act definition has one code. 

13.1.4.3 Code system is 2.16.840.1.113883.3.26.1.1 

13.1.4.4 Display name matches the code

13.1.4.5 The code comes from the business operations list. 

13.1.4.6 The business operation code is one of the following: API Manufacture 

(C82401), FDF Manufacture (C101510), Positron Emission Tomography Drug 

Production (C91403), Clinical Bioequivalence or Bioavailability Study 

(C101511), In Vitro Bioequivalence or Bioanalytical Testing (C101512), 

API/FDF Analytical Testing (C101509), Pack (C84731), and Repack (C73606).

13.1.4.7 Each business operation code and qualifier is mentioned only once per facility. 

13.1.5 Business Operation Qualifier 

The information for all facilities submitted in a Generic Drug Facility Identification 

Submission and Identification of CBER-regulated Generic Drug Facility indicates 

that the sites are implicitly engaged in the production of generic drugs. A “nongeneric qualifier” can be used to mark these facilities as also engaged in the 

production of non-generic (brand, innovator) drugs: 

<performance> 

 <actDefinition> 

 ... 

 <subjectOf> 

 <approval> 

 <code code="C101886" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufactures non-generics"/> 

 </approval> 

 </subjectOf> 

Validation Procedures 

13.1.5.1 There is zero or up to two business operation qualifiers. 

13.1.5.2 The qualifier has one code.

13.1.5.3 Code system is 2.16.840.1.113883.3.26.1.1 
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152 

13.1.5.4 Display name matches the code 

13.1.5.5 The code is Manufactures Non-Generics (C101886) and/or Contract 

Manufacturing (C132491)

13.1.5.6 If the business operation qualifier is Contract Manufacturing (C132491), then 

business operation is FDF Manufacture (C101510) or Pack (C84731).

13.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 

13.2.1.1 The document body is empty 
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14 [RESERVED]
15 Indexing - Product Concept

154 

15 Indexing - Product Concept

15.1 Header

15.1.1 Document type 

<document> 

 <code code="73815-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Indexing - Product Concept"/> 

Validation Procedures 

15.1.1.1 Document code is as above 

15.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type.

15.1.2 Author information 

Product concept indexing is maintained by FDA: 

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

15.1.2.1 Author information for Product Concept indexing is as one of the above 

15.1.3 Reference Labeling

The information about a product concept is derived from Reference Labeling. The 

Reference Labeling is found in the SPL document submitted by the innovator, or, if 

the innovator has stopped marketing the product, by a designated generic 

manufacturer. The SPL document containing the Reference Labeling is specified 

using its setId as follows: 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="DRIV"> 

 <relatedDocument> 

 <setId root="20d9b74e-e3d8-4511-9df9-cec2087372fc"/> 

 </relatedDocument> 

 </relatedDocument> 

<component .../> 

</document> 
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Validation Procedures 

15.1.3.1 There is reference labeling specified.

15.1.3.2 Type code attribute is as above.

15.1.3.3 There is no document id

15.1.3.4 There is a set id

15.1.3.5 Set id is a GUID

15.1.3.6 Reference labeling set id is the set id of a drug listing document.

15.1.3.7 If a product concept indexing file for the same reference labeling set id has been 

previously submitted, then it is a prior version of this indexing document with 

the same set id. 

15.1.3.8 If a document with the same set id has been previously submitted, then it is 

associated with the same reference labeling set id.

15.2 Body

<section> 

 <id root="ffabedf9-6bde-4787-beb0-abd214307427"/> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL Indexing Data Elements Section"/> 

 <title/> 

 <text/> 

 <effectiveTime value="20101007"/> 

 <subject> 

15.2.1 Product Concept Indexing Section 

15.2.1.1 If the document type is 73815-3, “Indexing - Product Concept"’, then the 

document contains one SPL Indexing Data Elements section as above. 

15.2.1.2 There is one or more product 

15.2.2 Abstract Product/Part Concept 

The Abstract Product Concept is based on the level 4 Pharmaceutical Product 

Identifier defined as a dose form with its active ingredients and strengths.

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="ba328d9b-c64c-fca9-2ee7-9882d2ac3f32" 

 codeSystem="2.16.840.1.113883.3.3389" /> 
15 Indexing - Product Concept

156 

 <formCode code="C42916" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="CAPSULE, EXTENDED RELEASE" /> 

 

Validation Procedures 

15.2.2.1 There is a product concept code with code system 2.16.840.1.113883.3.3389. 

15.2.2.2 Code has the format of 8-4-4-4-12 hexadecimal digits where letter digits are 

lower case.

15.2.2.3 Code value matches the specified properties according to the Abstract Product 

Concept Code Specification (See 15.2.4).

15.2.2.4 There is a form code and it comes from the Product Concept Dosage Form List 

15.2.3 Ingredient 

<ingredient classCode="ACTIM, ACTIB, or ACTIR"> 

 <quantity> 

 <numerator value="10" unit="mg"/> 

 <denominator value="1" unit="1"/> 

 </quantity> 

 <ingredientSubstance> 

 <code code="1234567890" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>tazminate malate</name> 

 <activeMoiety> 

 <activeMoiety> 

 <code code="76I7G6D29C" codeSystem="2.16.840.1.113883.4.9" /> 

 <name>MORPHINE</name> 

 </activeMoiety> 

 </activeMoiety> 

 </ingredientSubstance> 

</ingredient> 

Validation Procedures 

15.2.3.1 If the ingredient’s basis of strength is the active moiety (class code is 

“ACTIM”), then one (and only one) active moiety, the actual basis of strength, 

is stated.

15.2.3.2 Active moiety has an active moiety UNII code.

15.2.3.3 If the ingredient’s basis of strength is a reference substance (class code is 

“ACTIR”), then that reference substance is specified.

15.2.3.4 If the ingredient has a basis of strength other then the reference substance, then 

there is no reference substance.

15.2.3.5 Abstract product concept code should not match with any other abstract or 

equivalent product concept code. 
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15.2.3.6 Reference substance has an ingredient UNII code.

15.2.4 Abstract Product Concept Code Specification

The product concept code is created by computing the MD5 digest over a data 

structure describing the concept code unambiguously and uniquely, i.e., the same 

product concept is described by this and only this descriptor, and hence, by this and 

only this hash code. MD5 hash codes are 128 bit (16 byte) number which, in 

hexadecimal presentation, is 32 digits long. The hexadecimal digits are formatted in 

groups of 8-4-4-12 digits separated by hyphens.

The data structure which is the input of the MD5 digest is a pipe-delimited sequence 

of form code (dose form) by NCI thesaurus code only, followed by the active 

ingredients separated by the “pipe delimiter” (“|”) in alphabetic order of their UNII 

code. Each active ingredient is represented by the active ingredient code and the 

strength.

The dosage form code may be more generalized than the dosage form used in the SPL 

Listing documents. For example, “powder for solution” the code is generalized to “for 

solution”. Some of these more abstract dosage form codes may not be included in the 

dosage form table that can be chosen for drug listing submissions. For instance, 

POWDER, FOR SUSPENSION (C42975) is generalized to FOR SUSPENSION 

(C42972). The mapping between the dosage forms can be found in the Product 

Concept Dosage Form list on the FDA web page.

When the basis of strength is the active moiety (ingredient/@classCodde = ‘ACTIM’) 

and the active moiety UNII is different from the active ingredient UNII, then the 

active moiety UNII is appended to the active ingredient UNII with a separating tilde 

(“~”) character. Likewise, if the basis of strength is a reference substance, 

(ingredient/@classCodde = ‘ACTIR’), then the active moiety UNII is appended to 

the active ingredient UNII with a separating tilde (“~”) character.

The strength expression must be normalized to account for the fact that 10 mg in 5 

mL are the same as 2 mg in 1 mL, and 1 g is the same as 1000 mg and appended with 

a pipe delimiter.

Example 1: Cefutoxime Axetil (Z49QDT0J8Z) powder for suspension (C42975) 125 

mg of Cefutoxime (moiety, O1R9FJ93ED) in 5 mL is put together as 

“C42972|Z49QDT0J8Z~O1R9FJ93ED|2.500e1 mg/mL”, for which the MD5 digest is 

“7fead104-1147-b435-1545-606b40a2cd6b”.

Exmaple 2: Trimetoprim (AN164J8Y0X) 160 mg and Sulfametoxazole 

(JE42381TNV) 800 mg tablet (C42998). is put together as: 

“C42998|AN164J8Y0X|160e-3 g|JE42381TNV|8.000e2 mg”, for which the MD5 

digest is “8663a93b-5627-7466-306d-fd794b7d268a”.
15 Indexing - Product Concept

158

The normalized strength is computed by (1) normalizing the units by scaling the 

numbers, (2) dividing the normalized strength numerator by the normalized 

denominator, and (3) writing out the normalized strength number and the combined 

unit.

The normalized unit for both numerator and denominator, and their factor is 

determined by the following 3 step algorithm: (1) if the unit is “1” the factor is 1 and 

the normalized unit symbol is the empty string; or (2) find the unit in the Table 17: 

Normalized Units; or (3) if the unit is entirely embraced in square brackets “[...]”, the 

factor is 1 and the normalized unit is unchanged.

Table 17: Normalized Units

Unit Kind of Quantity Factor Normalized Unit

mmol amount of substance 1 mmol

nmol amount of substance 10-3 mmol

meq amount of valence 1 meq

cm2 Area 1 cm2

d elapsed time 86400 s

h elapsed time 3600 s

min elapsed time 60 s

U katalytic activity 1 U

g Mass 103 mg

kg Mass 106 mg

mg Mass 1 mg

ng Mass 10-6 mg

ug Mass 10-3 mg

Ci Radioactivity 37 103 MBq

mCi Radioactivity 37 MBq

L Volume 103 mL

mL Volume 1 mL

uL Volume 10-3 mL

All units which are entirely enclosed in in brackets are represented as is with the 

trivial conversion factor 1.

With this the normalized strength value is computed as:

(normalized strength number) =

(strength numerator number) × (conversion factor of numerator unit)

÷ [ (strength denominator number) × (conversion factor of denominator unit) ]

In this example 125 mg in 5 mL, this is trivial because the conversion factors are 1.

(strength numberator number) = 125

(conversion factor of numerator unit mg) = 1

(strength denominator number) = 5

(conversion factor of denominator unit mL) = 1
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(normalized strength number) =

125 × 1

÷ ( 5 × 1 ) = 25. 

If the strength had been written as 125 g in 5 L, the calculation would be:

(strength numerator number) = 125

(conversion factor of numerator unit g) = 1000

(strength denominator number) = 5

(conversion factor of denominator unit L) = 1000

(normalized strength number) =

125 × 1000

÷ ( 5 × 1000 ) = 25

Finally, the combined normalized strength number is written in the scientific notation 

in the format “-9.000e-9”, where “-9.000” means 4 digits, always starting with a nonzero digit before the decimal point, with an optional negative sign, and the decimal

point always in the same position, “e” (lower case) is the exponent marker, verbatim 

as a lower case “e”, and “-9” is the exponent to base 10, with the optional negative 

sign followed by however many digits are required, but no zero padding. Examples 

25 is formatted as “2.500e1”, 0.3766667 as “3.767e-1”, and 250 × 1010 as 

“2.500e12.

The normalized formatted strength number is followed by a space and then the 

normalized numerator unit, followed by a solidus (or “forward slash”, “/”) and the 

normalized denominator unit. For example, “mg” in “mL” becomes “mg/mL”). If the 

normalized denominator unit symbol is the empty string (i.e., the denominator unit 

was “1”), no solidus is appended (e.g., “mg” and the empty string becomes “mg”, not 

“mg/” nor “mg/1”). No attempt at canceling numerator and denominator units is made 

(e.g., “mg/mg” stays unchanged and is not reduced to 1.)

15.2.5 Abstract Kit Concept Code Specification

The product kit concept code is created by computing the MD5 digest over a data 

structure describing the concept code unambiguously and uniquely. The format of the 

kit concept code is the same as that of the product concept code expalined in Section 

15.2.4

If the form code is "kit" (C47916), the input of the MD5 digest is a pipe-delimited 

sequence of form code (C47916) followed by the product concept code and quantity 

of each part in alphabetic order of their product concept codes.

The quantity of the part must be normalized to account for the fact that 1 g is the 

same as 1000 mg, etc. as explained in the previous section for the normalization of 

strength and strength unit. The denominator value for part quantity will be always 1 

and the normalization rules simplify to:
15 Indexing - Product Concept

160

The normalized part quantity is computed by (1) normalizing the numerator unit by 

scaling the number and (2) writing out the normalized part quantity numerator 

number and unit.

The normalized part quantity numerator unit and its factor is determined by the 

following 3 step algorithm: (1) if the unit is “1” the factor is 1 and the normalized unit 

symbol is the empty string; or (2) find the unit in the Table 17: Normalized Units; or 

(3) if the unit is entirely embraced in square brackets “[...]”, the factor is 1 and the 

normalized unit is unchanged.

Exmaple: a kit with 16.8 mL of part A (abstract concept code a46c150b-8203-ac62-

31ef-adb5c0aca5a2) and 0.9 g of part B (abstract concept code bdce178d-00b2-6beb4d96-259f444aee1d).

With this the normalized part quantity value is computed for each part as:

(normalized part quantity numerator number) =

(part quantity numerator number) × (conversion factor of numerator unit)

In this example, part 1: 16.8 mL:

(part quantity numerator number) = 16.8

(conversion factor of numerator unit mg) = 1

(normalized part quantity number) = 16.7 × 1 = 25. 

(normalized part quantity unit) = mL.

Part 2: 0.9 g

(part quantity numerator number) = 0.9

(conversion factor of numerator unit mg) = 1000

(normalized part quantity number) = 0.9 × 1000 = 900. 

(normalized part quantity unit) = mg.

Finally, the normalized part quantity number is written in the scientific notation in the 

format “-9.000e-9”, where “-9.000” means 4 digits, always starting with a non-zero 

digit before the decimal point, with an optional negative sign and the decimal point 

always in the same position, “e” (lower case) is the exponent marker, verbatim as a 

lower case “e”, and “-9” is the exponent to base 10, with the optional negative sign 

followed by however many digits are required, but no zero padding. Examples 16.8 is 

formatted as “1.680e1”, 900 as “9.000e2”, and 0.25 as “2.500e-1.

The normalized formatted part quantity number is followed by a space and then the 

normalized numerator unit.
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In this example; “C47916|a46c150b-8203-ac62-31ef-adb5c0aca5a2|1.680e1 mL|

bdce178d-00b2-6beb-4d96-259f444aee1d|9.000e2 mg”, for which the MD5 digest is 

“a76b62f9-257b-7918-620e-4db706c928f8”. 

15.2.6 Application Product/Kit Concept 

The Application Product Concept includes the marketing application identifier in 

addition to the dose form with its active ingredients and strengths. 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="d5ecf7af-bb51-2003-61fe-b81973321293" 

 codeSystem="2.16.840.1.113883.3.3389"/> 

 <asEquivalentEntity classCode="EQUIV"> 

 <code code="A" codeSystem="2.16.840.1.113883.3.2964"/> 

 <definingMaterialKind> 

 <code code="41b5afb1-84d4-83c3-f095-5557b06994a0" 

 codeSystem="2.16.840.1.113883.3.3389"/> 

 </definingMaterialKind> 

 </asEquivalentEntity> 

Validation Procedures 

15.2.6.1 There is an product/kit concept code with code system 

2.16.840.1.113883.3.3389 

15.2.6.2 Code has the format of 8-4-4-4-12 hexadecimal digits where letter digits are 

lower case.

15.2.6.3 Code value matches the specified properties according to the Application 

Product Concept Code Specification (See 15.2.8). 

15.2.6.4 There is no form code. 

15.2.6.5 There is an equivalent product reference.

15.2.6.6 There is an equivalence code with code system 2.16.840.1.113883.3.2964. 

15.2.6.7 Equivalence code is “A”, “B”, “OTC”, or “N”.

15.2.6.8 Equivalent product/kit concept code should not match with any other abstract or 

equivalent product/kit concept code. 

15.2.6.9 There is a product/kit concept reference with code and code system same as 

another product/kit concept code of an Abstract or Application Product Concept 

in the same document. 
15 Indexing - Product Concept

162 

15.2.7 Marketing Category and Application Number 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <asEquivalentEntity> ... </asEquivalentEntity> 

 </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <id extension="NDA021223" root="2.16.840.1.113883.3.150" /> 

 <code code="C73594" codeSystem="2.16.840.1.113883.3.26.1.1" 

displayName="NDA" /> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3" /> 

 </territory> 

 </territorialAuthority> 

 </author> 

 </approval> 

 </subjectOf> 

 </manufacturedProduct> 

 </subject> 

Validation Procedures 

15.2.7.1 There is one marketing category for every Product Equivalence 

15.2.7.2 The marketing authorization should only be ANDA, BLA or NDA 

15.2.8 Application Product/Kit Concept Code Specification 

The Application Product Concept code is created by computing the MD5 digest over 

a data structure describing the Application Product concept code unambiguously and 

uniquely, i.e., the same equivalent product concept is described by this and only this 

descriptor, and hence, by this and only this hash code. MD5 hash codes are 128 bit 

(16 byte) number which, in hexadecimal presentation, is 32 digits long. The 

hexadecimal digits are formatted in in groups of 8-4-4-12 digits separated by 

hyphens. 

The data structure which is the input of the MD5 digest is a pipe-delimited sequence 

of abstract product concept code and the application number separated by the “pipe 

delimiter” (“|”).

Example 1: Cefutoxime Axetil (Z49QDT0J8Z) powder for suspension (C42975) 125 

mg of Cefutoxime (moiety, O1R9FJ93ED) in 5 mL is put together as 

“C42972|Z49QDT0J8Z~O1R9FJ93ED|2.500e1 mg/mL”, for which the MD5 digest is 

“7fead104-1147-b435-1545-606b40a2cd6b”. That is the abstract product concept. 

Example 1a: a powder for suspension for 125 mg in 5 mL has the application number 

NDA050672, so its Application Product Concept is the MD5 hash of “7fead104-
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1147-b435-1545-606b40a2cd6b|NDA050672” which is “3b35d65f-9dc2-104c-e6be8df3d2dfb11d”.

Example 1b: Cefutoxime Axetil by Choice Pharma LLC for suspension for 125 mg in 

5 mL may have the application number ANDA987654, so its Application Product 

Concept is the MD5 hash of “7fead104-1147-b435-1545-

606b40a2cd6b|ANDA987654” which is “08007c2a-e9e4-0427-ea61-4d8197b2ef24”.

Exmaple 2: For abstrct product kit concept, MD5 digest is the sequence of form code 

(kit, C47916) followed by the abstract product concept code and normalized part 

quantity in alphabetic order of the abstract product concept code put together as 

"C47916|a46c150b-8203-ac62-31ef-adb5c0aca5a2|1.680e1 mL|bdce178d-00b2-6beb4d96-259f444aee1d|9.000e2 mg", for which the MD5 digest is “a76b62f9-257b7918-620e-4db706c928f8”. This is the abstract product kit concept code.

Example 2a: For application number BLA456789, Applicaiton Product Kit Concept 

is the MD5 hash of “a76b62f9-257b-7918-620e-4db706c928f8|BLA456789” which is 

“a071563f-e74e-a06c-33c2-2c4aeec1b950”.

Note: the concept hash code for an Application Product Concept is always formed 

from the Abstract Product Concept and the application number despite the fact that 

the ANDA equivalent product references the referenced product as its equivalent. The 

Application Product Concept however is Independent of the choice of equivalence 

product only dependent on the Abstract Product Concept and the application number.
16 Lot Distribution Report

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16 Lot Distribution Report

16.1 SPL Header

16.1.1 Document type 

<document> 

 <id root="50606941-3e5d-465c-b4e0-0f5a19eb41d4"/> 

 <code code="66105-8" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Lot Distribution Data"/> 

<effectiveTime value="2010701"/> 

 <setId root="a30accef-f437-4136-808c-9ed4ada5fcf8"/> 

 <versionNumber value=“1”/> 

Validation Procedures 

16.1.1.1 Document code is as above 

16.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type.

16.1.2 Author information 

<author> 

 <representedOrganization> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <id extension="Manufacturer License Number" 

root="1.3.6.1.4.1.32366.1.3.1.2"/> 

 <name>Zwerg Pharma, Inc.</name> 

 <contactParty> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

 <contactPerson> 

 <name>Bob Jones</name> 

 </contactPerson> 

 </contactParty> 

16.1.2.1 There is one author (labeler)

16.1.2.2 There are two ids

16.1.2.3 One id is the DUNS number with the root 1.3.6.1.4.1.519.1 with a 9-digit 

extension

16.1.2.4 One id is the manufacturer license number with the root 

1.3.6.1.4.1.32366.1.3.1.2 with a 4-digit extension

16.1.2.5 There may be one contact party (see the Procedures for contact party above)

16.1.2.6 Contact party has an email address specified.
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16.1.3 Bulk-Lot Manufacturers 

The manufacturing establishments which will be referred to in the bulk lot suppliers 

are listed here.

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> <!-- Labeler --> 

 <assignedEntity> 

 <assignedOrganization> <!-- Registrant --> 

<assignedEntity><!-- Bulk-Lot Manufacturer 1 --> 

 <confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

 <assignedOrganization> <!-- Establishment --> 

 <id extension="1000000019" root="1.3.6.1.4.1.519.1"/> 

 <name>Middleton Manufacturing company</name> 

 </assignedOrganization> 

</assignedEntity> 

<assignedEntity><!-- Bulk-Lot Manufacturer 2 --> 

 ... 

Validation Procedures 

16.1.3.1 There are one or more bulk lot manufacturers.

16.1.3.2 There is no registrant information. 

16.1.3.3 Bulk-lot manufacturer has one id (the DUNS number) and a name as in Section 

2.1.5. 

16.1.3.4 Each bulk-lot manufacturer appears only once. 

16.1.3.5 Bulk-lot manufacturer (“assignedOrganization”) has no other element besides id 

(the DUNS Number) and name.

16.1.3.6 The bulk-lot manufacturer id (DUNS Number) has been submitted in a 

document of type “Establishment Registration” (51725-0) on or after October 

1st of the previous year, or, if earlier, that Establishment Registration has been 

followed by a document of type “No Change Notification” (53410-7) between 

October 1st and December 31st of the previous or the current year. 
16 Lot Distribution Report

166 

16.2 Body

<component> 

 <section> 

 <id root="e13a985b-f706-a5c8-e8ef-73891eb1c697"/> 

 <code code="48780-1" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <effectiveTime> 

 <low value="20100101"/> 

 <high value="20100701" closed="false"/> 

 </effectiveTime> 

Validation Procedures 

16.2.1.1 There is a document body 

16.2.2 Data Elements Section 

16.2.2.1 There is an SPL Data Elements section

16.2.2.2 Effective time has low and high boundaries indicating the reporting period of the 

lot distribution data (reporting start date, reporting end date). 

16.2.2.3 Reporting start date has at least the precision of day in the format 

YYYYMMDD

16.2.2.4 Reporting end date has at least the precision of day in the format YYYYMMDD 

16.2.2.5 Reporting start date is before reporting end date.

16.2.2.6 Reporting end date is the same as value of effective time in document 

information. 

16.2.2.7 Period of time represented by the reporting start and end date should not exceed 

365 days. 

16.2.2.8 Period of time represented by the reporting start and end date should not be less 

than 14 days. 
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16.2.3 Product Data – Single Licensed Product 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="1234-5678" codeSystem="2.16.840.1.113883.6.69"/> 

 <name>Multivax</name> 

 <formCode code="C42973" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="POWDER, FOR SOLUTION"/> 

 <ingredient classCode="ACTIB"> 

 <ingredientSubstance > 

 <code code="KZ3L01D2PC" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>HUMAN VIRUS ANTIGEN</name> 

 </ingredientSubstance> 

 </ingredient> 

 <instanceOfKind> 

 <!-- DISTRIBUTION DATA, SEE BELOW --> 

 </instanceOfKind> 

 </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <id extension="BLA123456" root="2.16.840.1.113883.3.150"/> 

 <code code="C73585" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="BLA"/> 

 </approval> 

 </subjectOf> 

 <consumedIn><!-- DOSING SPECIFICATION --></consumedIn> 

 </manufacturedProduct> 

 </subject> 

</section> 

16.2.3.1 There is one or more subject manufactured products: 

16.2.3.2 There is an NDC product code 

16.2.3.3 The general rules about the product item code apply as per 3.1.1.1ff.

16.2.3.4 There is a trade name

16.2.3.5 Name contains no special symbols (e.g., no “®” or “TM” etc) and no “USP” or 

dosage forms. 

16.2.3.6 Name matches the NDC code submitted in drug listings.

16.2.3.7 NDC product item code has been previously submitted in an SPL listing file. 

16.2.3.8 There are no other product data elements, such as generic name, product source, 

inactive ingredients, etc.

16.2.3.9 The same product is not described in a lot distribution report with a different set 

id. 

16.2.3.10 There is no lot distribution report with the same set id but a different product. 
16 Lot Distribution Report

168 

16.2.4 Dosing Specification 

The dosing specification is used to compute the number of doses in any lot, or 

container, such as to comply with the number of doses in fill lot/label lot requirement 

specified by the regulation.

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct><!-- NDC AND NAME --></manufacturedProduct> 

 <consumedIn> 

 <substanceAdministration1 classCode=“SBADM” moodCode=“DEF”> 

 <routeCode code="C38288" displayName="oral" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <doseQuantity value="1" unit="mL"/> 

 </substanceAdministration1> 

 </consumedIn> 

Validation Procedures 

16.2.4.1 There is a dosing specification element.

16.2.4.2 There is a route code, and the rules for route of administration code apply 

(3.2.20.2f).

16.2.4.3 There is a dose quantity specification with a single value and unit, except for 

variable dose, which do not have the dose quantity element. 

16.2.4.4 Value is a number

16.2.4.5 Unit comes from the UCUM units of measures list

16.2.4.6 Value may be the number “0”.

16.2.4.7 Value should not include spaces. 

16.2.5 Fill Lot 

The fill lot is the lot of product which conforms to the specification of the product 

regardless of packaging, i.e., it has the form and the strength specified by the listing 

data for the package-Independent NDC of the product. As such the fill lot is an 

instance of the product regardless of packaging. 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance><!-- FILL LOT --> 

 <id root="{Fill Lot ID root OID}" extension="{Fill Lot ID}"/> 
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Validation Procedures 

16.2.5.1 There is a fill lot element

16.2.5.2 The lot has an id with the following general rules for lot numbers: 

16.2.5.3 There is an id extension with the reported alphanumeric lot number string 

16.2.5.4 Lot number string can contain digits, upper case letters and the characters “-” 

and “/”.

16.2.5.5 There is a globally unique root OID 

16.2.5.6 If the product item code is an NDC, then the globally unique root OID is formed 

by using the fixed prefix "1.3.6.1.4.1.32366.1.2.10." followed by the NDC 

product item code represented as a number without dashes and with initial 

zeroes from the labeler code segment removed (e.g., "0001-0123" becomes 

10123). 

16.2.5.7 If the product item code is an ISBT 128 code, then the globally unique root OID 

is formed by using the fixed prefix “1.3.6.1.4.1.32366.1.2.13.” followed by a 

decimal number value for the ISBT 128 facility identification number followed 

by a period “.” and a decimal number value for the ISBT 128 product code, both 

interpreted as a base 36 number with the digits 0-9 and A-Z, with the letter digits 

having the value of 9 added to the ordinal letter position (A: 1 + 9 = 10, B = 2 + 

9 = 11, ..., Z = 26 + 9 = 35); e.g., ISBT 128 product item code “W0123-E0404” 

with facility identification number “W0123” interpreted in base 36: W = 23 + 9 

= 32 × 36 + 0) × 36) + 1) × 36 + 2) × 36 + 3 = 53749083, and ISBT 128 product 

code “E0404” interpreted in base 36: E = 5 + 9 = 14 × 36 + 0) × 36 + 4 ) × 36 

+ 0) × 36 + 4 = 23519812, resulting in 

“1.3.6.1.4.1.32366.1.2.13.53749083.23519812”. 

16.2.6 Bulk Lot(s) 

Bulk lot is the instance of raw material that goes into one or more fill lots at possibly 

different strengths. As such the bulk lot represents one or more ingredient instances. 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance><!-- FILL LOT --> 
16 Lot Distribution Report

170 

<ingredient><!-- BULK LOT(S) --> 

 <ingredientProductInstance> 

 <id root="{Bulk Lot ID root OID}" extension="{Bulk Lot ID}"/> 

 <asInstanceOfKind> 

 <kindOfMaterialKind> 

 <code code="XYZ123ABC" codeSystem="2.16.840.1.113883.4.9"/> 

 <name>Mucinella Bobadis Antigen</name> 

 </kindOfMaterialKind> 

 </asInstanceOfKind> 

 </ingredientProductInstance> 

 <subjectOf> 

 <productEvent> 

 <code code="C43360" displayName="manufacture" 

 codeSystem="2.16.840.1.113883.3.26.1.1”/> 

 <performer> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="DUNS number"/> 

Validation Procedures 

16.2.6.1 There is one or more bulk lot elements 

16.2.6.2 The lot has an id, and the general rules for lot numbers apply. 

16.2.6.3 If the product item code is an NDC, then the globally unique root OID is formed 

by using the fixed prefix "1.3.6.1.4.1.32366.1.2.10." followed by the NDC 

Labeler Code represented as a number without initial zeroes (e.g., "0001" 

becomes 1).

16.2.6.4 If the product item code is an ISBT 128 code, then the globally unique root OID 

is formed by using the fixed prefix “1.3.6.1.4.1.32366.1.2.13.” followed by a 

decimal number value for the ISBT 128 facility identification number 

interpreted as a base 36 number with the digits 0-9 and A-Z, with the letter digits 

having the value of 9 added to the ordinal letter position (A: 1 + 9 = 10, B = 2 + 

9 = 11, ..., Z = 26 + 9 = 35); e.g., ISBT 128 facility identification number 

“W0123” interpreted in base 36: W = 23 + 9 = 32 × 36 + 0) × 36) + 1) × 36 + 2) 

× 36 + 3 = 53749083, resulting in “1.3.6.1.4.1.32366.1.2.13.53749083”. 

16.2.6.5 The bulk lot references an active ingredient 

16.2.6.6 Code system is 2.16.840.1.113883.4.9 

16.2.6.7 There is one ingredient name

16.2.6.8 Ingredient name matches the code

16.2.6.9 The ingredient is actually listed as an ingredient of the product 

16.2.6.10 The bulk lot references one manufacturer (C43360). 
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16.2.6.11 There is one id

16.2.6.12 id is the DUNS number of the bulk lot manufacturing establishment with the 

root 1.3.6.1.4.1.519.1 and a 9-digit extension

16.2.6.13 Bulk-lot manufacturer (“representedOrganization”) has no other element 

besides id. 

16.2.6.14 The bulk-lot manufacturer id is one of those listed in the bulk-lot 

manufacturers in the header. 

16.2.6.15 The establishment id matches an establishment with same id submitted in 

documents of type “establishment registration” in the same or previous calendar 

year with business operation manufacture (C43360) or API manufacture 

(C82401). 

16.2.6.16 The bulk lot references no other product activity 

16.2.7 Label Lot(s) (Final Container Lot) 

The label lot, or final container lot is the instance of the product, a portion of the fill 

lot that is portioned out into individual containers. 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance><!-- FILL LOT --> 

 <ingredient><!-- BULK LOT(S) --></ingredient> 

 <member><!-- LABEL LOT --> 

 <memberProductInstance> 

 <id root="{Label Lot ID root OID}" extension="{Label Lot ID}"/> 

 <expirationTime> 

 <high value="20110417"/> 

 </expirationTime> 

Validation Procedures 

16.2.7.1 There is one or more label lot elements

16.2.7.2 The lot has an id, and the general rules for lot numbers apply. 

16.2.7.3 If the product item code is an NDC, then the globally unique root OID is formed 

by using the fixed prefix "1.3.6.1.4.1.32366.1.2.10." followed by the full 10-

digit NDC code represented as a number without dashes and with initial zeroes 

from the labeler code segment removed (e.g., "0001-0123-04" becomes 

1012304). 

16.2.7.4 If the product item code is an ISBT 128 code, then the globally unique root OID 

is formed by using the fixed prefix “1.3.6.1.4.1.32366.1.2.13.” followed by a 

decimal number value for the ISBT 128 facility identification number followed 
16 Lot Distribution Report

172 

by a period “.” and a decimal number value for the ISBT 128 product code, both 

interpreted as a base 36 number with the digits 0-9 and A-Z, with the letter digits 

having the value of 9 added to the ordinal letter position (A: 1 + 9 = 10, B = 2 + 

9 = 11, ..., Z = 26 + 9 = 35), and ending with a period “.” and the 3rd segment of 

the ISBT 128 package item code without leading zeroes; e.g., ISBT 128 product 

item code “W0123-E0404-03” with facility identification number “W0123” 

interpreted in base 36: W = 23 + 9 = 32 × 36 + 0) × 36) + 1) × 36 + 2) × 36 + 3 

= 53749083, and ISBT 128 product code “E0404” interpreted in base 36: E = 5 

+ 9 = 14 × 36 + 0) × 36 + 4 ) × 36 + 0) × 36 + 4 = 23519812, and 3rd segment 

“03” without zeroes, resulting in 

“1.3.6.1.4.1.32366.1.2.13.53749083.23519812.3”. 

16.2.7.5 There is an expiration time with a high boundary. 

16.2.7.6 Expiration time has at least the precision of month in the format YYYYMM

16.2.8 Container Data Elements 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance><!-- FILL LOT --> 

 <ingredient><!-- BULK LOT(S) --></ingredient> 

 <member><!-- LABEL LOT --> 

 <memberProductInstance> 

<asContent> 

 <quantity> 

 <numerator value="2" unit="mL"/> 

 <denominator value="1" unit="1"/> 

 </quantity> 

 <container> 

 <code code="1234-5678-01" codeSystem="2.16.840.1.113883.6.69"/> 

 <formCode code="C43169" displayName="bottle" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </container> 

Validation Procedures 

16.2.8.1 There is a container reference

16.2.8.2 There is a quantity with a numerator and denominator 

16.2.8.3 Numerator has a value greater than zero and a unit

16.2.8.4 Numerator unit matches the dosing specification unit. 

16.2.8.5 Denominator has value 1 and either no unit or unit “1” 

16.2.8.6 The container form code and quantity is the same as the package of the product 

as described in the listing for the package NDC. 
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16.2.8.7 There is a container packaged product code

16.2.8.8 Container packaged product item code is an NDC or based on ISBT-128 

16.2.8.9 There is a form code and display name 

16.2.8.10 Code system for form code is 2.16.840.1.113883.3.26.1.1 

16.2.8.11 Display name matches form code

16.2.8.12 The container form code matches the form code specified for the container in 

the listing data.

16.2.9 Containers Distributed 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance><!-- FILL LOT --> 

 <ingredient><!-- BULK LOT(S) --></ingredient> 

 <member><!-- LABEL LOT --> 

 <memberProductInstance> 

 <asContent> 

 <container><!-- container reference --></container> 

<subjectOf> 

 <quantity value="1000" unit="1"/> 

 <productEvent> 

 <code code="C106325" 

 displayName="Distributed per reporting interval" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <effectiveTime> 

 <low value="20100101"/> 

 </effectiveTime> 

 </productEvent> 

</subjectOf> 

Validation Procedures 

16.2.9.1 There are one or more product events

16.2.9.2 There is one quantity (Final Containers Distributed) 

16.2.9.3 Quantity value is the integer number of final containers distributed. 

16.2.9.4 Quantity unit is “1” or there is no unit. 

16.2.9.5 There is a product event code

16.2.9.6 Code system is 2.16.840.1.113883.3.26.1.1 
16 Lot Distribution Report

174 

16.2.9.7 The code is from the LDD Distribution Codes list and display name matches the 

code.

16.2.9.8 There is one distribution product event 

16.2.9.9 Container distribution event has an effective time with low boundary specifying 

the Initial Distribution Date.

16.2.9.10 Initial distribution date has at least the precision of day in the format 

YYYYMMDD

16.2.9.11 There should be a initial distribution date. 

16.2.10 Containers Returned Data 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance><!-- FILL LOT --> 

 <ingredient><!-- BULK LOT(S) --></ingredient> 

 <member><!-- LABEL LOT --> 

 <memberProductInstance> 

 <asContent> 

 <container><!-- container reference --></container> 

<subjectOf> 

 <quantity value="1000" unit="1"/> 

 <productEvent> 

 <code code="C106328" 

 displayName="Returned" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </productEvent> 

</subjectOf> 

16.2.10.1 There is one returned product event 

16.2.10.2 Returned product event has no effective time 

16.2.10.3 There is no other product event 

16.2.11 Product Data – Kit with Multiple Licensed Products 

When the licensed product is only part of a kit, but the kit itself is not tracked as a 

“package lot”, the lot data is specified under the appropriate part of the kit, and all the 

validation procedures specified for fill lot, bulk lot and label lot apply as above. 
SPL Implementation Guide with Validation Procedures v1

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<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="1234-5679" codeSystem="2.16.840.1.113883.6.69"/> 

 <name p:de="Trade Name">Multivax (MixKit)</name> 

 <part> 

 <partProduct> 

 <instanceOfKind> 

 <productInstance> 

If in addition the kit itself is tracked as a “package lot”, then the package lot data is 

specified for the entire kit as follows:

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="1234-5679" codeSystem="2.16.840.1.113883.6.69"/> 

 <name p:de="Trade Name">Multivax (MixKit)</name> 

 <instanceOfKind> 

 <productInstance><!-- PACKAGE LOT --> 

 <id root="{Package Lot root OID}" extension="{Package Lot ID}"/> 

 <part><!-- LABEL LOT --> 

 <partProductInstance> 

 <id root="{Label Lot root OID}" extension="{Label Lot ID}"/> 

 </partProductInstance> 

 </part> 

 </productInstance> 

 <subjectOf><!-- product events --></subjectOf> 

 </instanceOfKind> 

Validation Procedures 

16.2.11.1 The rules for product code and name are as for simple products 

16.2.11.2 There is one or more parts, referencing label lots of these parts.

16.2.11.3 There is a product event code

16.2.11.4 There is a label lot specified elsewhere in the lot distribution report.

16.2.11.5 There are one or more product events

16.2.11.6 There is one distribution product event 

16.2.11.7 There may be one returned product event 

16.2.11.8 There is no other product event 
17 [RESERVED]

176

17 [RESERVED]
SPL Implementation Guide with Validation Procedures v1

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18 Wholesale Drug Distributor/Third-Party Logistics Facility 

Report 

Wholesale Drug Distribution submissions have only header information with data for 

one or more reported facilities. 

18.1 Header

18.1.1 Document type 

<document> 

 <code code="75030-7" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="wholesale drug distributor/third-party logistics 

facility reporter"/> 

Validation Procedures 

18.1.1.1 Document type is Wholesale Drug Distributors and Third-Party Logistics 

Facility Report (75030-7) 

18.1.1.2 The effective time year matches the current year.

18.1.1.3 There is no title.

18.1.1.4 If a document with the same set id has been previously submitted, then it is a 

Wholesale Drug Distributors and Third-Party Logistics Facility Report (75030-

7).

18.1.1.5 For Withdrawal of Wholesale Drug Distributors and Third-Party Logistics 

Facility Report (77573-4) the set id in this document should be the same set id 

included in a previously submitted Wholesale Drug Distributors and ThirdParty Logistics Facility Report (75030-7), with information about your 

establishment(s).

18.1.2 Reporter information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- facility, may be pass-through --> 

 <assignedEntity> 

<assignedOrganization> <!-- reporter --> 

 <id extension="100000002" root="1.3.6.1.4.1.519.1"/> 

 <name>ACME Drug Logistics, Inc.</name> 

 <contactParty> 
18 Wholesale Drug Distributor/Third-Party Logistics Facility Report

178 

Validation Procedures 

18.1.2.1 If the document type is Wholesale Drug Distributors and Third-Party Logistics 

Facility Report (75030-7), then there is reporter information. 

18.1.2.2 There is one id (the DUNS Number) and name as in Section 2.1.5. 

18.1.2.3 id (reporter’s DUNS Number) is not associated with any other set id of 

document type Wholesale Drug Distributors and Third-Party Logistics Facility 

Report (75030-7) 

18.1.2.4 The set id is not associated with any other reporter id (DUNS Number). 

18.1.2.5 There is one contact party as in Section 2.1.8. 

18.1.2.6 The Reporter's DUNS number matches the DUNS number record in the Dun and 

Bradstreet database. 

18.1.2.7 Facility submission has no labeler information (no validation rules defined for 

it.)

18.1.3 Facility Information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

<confidentialityCode code="B" codeSystem="2.16.840.1.113883.5.25"/> 

<assignedOrganization> <!-- facility --> 

 <id root="1.3.6.1.4.1.519.1" extension="449819433"/> 

 <name>Acme, LLC</name> 

 <addr> 

 <streetAddressLine>325 Good Hope Avenue</streetAddressLine> 

 <city>Milwaukee</city> 

 <state>WI</state> 

 <postalCode>53014</postalCode> 

 <country code="USA" codeSystem="1.0.3166.1.2.3">USA</country> 

 </addr> 

 <asNamedEntity> <!-- other “doing business as” name --> 

 <code code="C117113" displayName="doing business as" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <name>A.C.M.E. Logistic</name> 

 </asNamedEntity> 

 <contactParty .../> 

The confidentiality code “B” may be used at the facility level to indicate that the 

street address of this facility should be suppressed in public data releases. 
SPL Implementation Guide with Validation Procedures v1

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Validation Procedures

18.1.3.1 If the document type is Wholesale Drug Distributors and Third-Party Logistics 

Facility Report (75030-7), then there are one or more facilities.

18.1.3.2 Facility has a name and optionally one id (the DUNS Number) as in Section 

2.1.5.

18.1.3.3 DUNS number, if present, is not associated with another facility in the same 

SPL file.

18.1.3.4 DUNS number, if present, is not associated with any other set id for document 

type Wholesale Drug Distributors and Third-Party Logistics Facility Report

(75030-7)

18.1.3.5 DUNS number, if present, along with the facility name and address information 

match the DUNS number record in the Dun and Bradstreet database

18.1.3.6 Each facility has an address as in Section 2.1.6.

18.1.3.7 There is one contact party as in Section 2.1.8.

18.1.3.8 There is no further assigned entity under the facility.

18.1.3.9 There may be zero or more “doing business as” names (DBA names).

18.1.3.10 DBA names has code C117113 and code system 2.16.840.1.113883.3.26.1.1.

18.1.3.11 DBA name has one name element.

18.1.3.12 There may be a suffix beginning with space, and the abbreviation WDD or 

3PL in square brackets.

18.1.3.13 If the suffix is [WDD], then one business operation for this facility is 

Wholesale Drug Distributor (C118411).

18.1.3.14 If the suffix is [3PL], then one business operation for this facility is ThirdParty Logistics Provider (C118412).

18.1.3.15 If the facility has the same “doing business as” (DBA) name regardless of 

business operation, then no suffix is specified.

18.1.3.16 The facility should not have the same “doing business as” (DBA) name with 

the same business operation.
18 Wholesale Drug Distributor/Third-Party Logistics Facility Report

180 

18.1.4 Facility Business Operation 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-through --> 

 <assignedEntity> 

 <assignedOrganization> <!-- reporter --> 

<assignedEntity> 

 <assignedOrganization> 

 <!-- facility --> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C118411" displayName="wholesale drug distribution" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

Validation Procedures 

18.1.4.1 There are one or two facility business operation details (performance act 

definitions). 

18.1.4.2 Act definition (business operation) code is Wholesale Drug Distributor

(C118411) or Third-Party Logistics Provider (C118412) and code system is 

2.16.840.1.113883.3.26.1.1. 

18.1.4.3 Act definition (business operation) display name matches corresponding 

business operation code. 

18.1.4.4 Each business operation code is mentioned only once per facility. 

18.1.4.5 There is no product reference.

18.1.5 License 

License information is specified as shown below: 

<performance> 

 <actDefinition> 

 <code code="C118411" displayName="wholesale drug distribution" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <subjectOf> 

 <approval> 

 <id extension="License Number" 

 root="State license authority OID (see text)"/> 

 <code code="C118777" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="licensing"/> 

 <statusCode code="License Status"/> 

 <effectiveTime> 

 <high value="License Expiration Date"/> 

 </effectiveTime> 
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181 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="State code from ISO 3166-2, e.g. US-MD" 

 codeSystem="1.0.3166.2"/> 

 </territory> 

 </territorialAuthority> 

 </author> 

Example:

<performance> 

 <actDefinition> 

 <code code="C118411" displayName="wholesale drug distribution" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <subjectOf> 

 <approval> 

 <id extension="2013-WL-123456" 

 root="1.3.6.1.4.1.32366.4.840.805"/> 

 <code code="C118777" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="licensing"/> 

 <statusCode code="completed"/> 

 <effectiveTime> 

 <high value="20140824"/> 

 </effectiveTime> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="US-MD" codeSystem="1.0.3166.2"/> 

 </territory> 

 </territorialAuthority> 

 </author> 

If the issuer of the license is not a state, but it is valid in the entire federal territory 

then the ISO 3166-1 country CODE “USA” is provided and the DUNS number of the 

federal agency.

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

 </territory> 

 <governingAgency><!-- if territory code is USA --> 

 <id extension=“Agency DUNS Number” root=“1.3.6.1.4.1.519.1”/> 

 <name>Agency Name</name> 

 </governingAgency> 

 </territorialAuthority> 

 </author> 

In case of the Drug Enforcement Agency (DEA) that DUNS number is 004234790. 
18 Wholesale Drug Distributor/Third-Party Logistics Facility Report

182 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

 </territory> 

 <governingAgency><!-- if territory code is USA --> 

 <id extension=“004234790” root=“1.3.6.1.4.1.519.1”/> 

 <name>DEA</name> 

 </governingAgency> 

 </territorialAuthority> 

 </author> 

Validation Procedures 

18.1.5.1 There is one or more licenses, except if the business operation is Third-Party 

Logistics Provider (C118412). 

18.1.5.2 License Code is from the License Type Code list. 

18.1.5.3 Display name matches the code.

18.1.5.4 Code system is 2.16.840.1.113883.3.26.1.1. 

18.1.5.5 If the license is issued by a state, then the territorial authority territory is 

specified with the ISO 3166-2 US state codes with code system 1.0.3166.2. 

18.1.5.6 License has an id with the license number. 

18.1.5.7 id has an extension, the license number. 

18.1.5.8 If the license is issued by a state authority, then the id has a root beginning with 

“1.3.6.1.4.1.32366.4.840” followed by a period “.” and a decimal number equal 

to the value of the 2-letter ISO 3166-2 U.S. state code interpreted as a base 36 

number with the digits 0-9 and A-Z, with the letter digits having the value of 9 

added to the ordinal letter position (A: 1 + 9 = 10, B = 2 + 9 = 11, ..., Z = 26 + 9 

= 35); e.g., Arizona, having the ISO 3166-2 “US-AZ”, i.e., the 2-letter state code 

“AZ” with (A =) (1 + 9) × 36 + (Z =) (26 + 9) = 10 × 36 + 35 = 395, resulting in 

“1.3.6.1.4.1.32366.4.840.395”. 

18.1.5.9 License has a status code with values active, suspended, aborted (meaning 

“revoked”), or completed (meaning “expired”).

18.1.5.10 License has an effective time high value (expiration date).

18.1.5.11 License has no effective time low value (license issue date not reported).

18.1.5.12 The effective time high boundary has at least the precision of day in the 

format YYYYMMDD
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18.1.5.13 If the status code is completed, then the current date is later than the effective 

time high value.

18.1.5.14 If the current date is later than the effective time high value, then the status 

code is not active.

18.1.5.15 The combination of license number, license type and business operation, and 

license issuing state is not associated with any other set id of document type 

Wholesale Drug Distributors and Third-Party Logistics Facility Report (75030-

7) (see also 18.1.5.16 for further details).

18.1.5.16 The license id root should be followed by a suffix “.2”, “.3”, “.4”, or “.5” as 

follows: “.2” for Third-Party Logistics Provider (C118412) facility in licensing 

state, “.3” for Wholesale Drug Distributor (C118411) facility in licensing state, 

“.4” for Third-Party Logistics Provider (C118412) out of licensensing state, and 

“.5” for Wholesale Drug Distributor (C118411) facility out of licensing state; in 

the absence of this suffix such suffix will be imputed for the purpose of the 

preceding procedure 18.1.5.15.

18.1.5.17 If the license id root has the suffix “.1”, then the license issuing state and the 

facility address state are not the same.

18.1.5.18 If the license id root has the suffix “.2”, then the business operation is ThirdParty Logistics Provider (C118412) and the license issuing state and the facility 

address state are the same.

18.1.5.19 If the license id root has the suffix “.3”, then the business operation is 

Wholesale Drug Distributor (C118411) and the license issuing state and the 

facility address state are the same.

18.1.5.20 If the license id root has the suffix “.4”, then the business operation is ThirdParty Logistics Provider (C118412) and the license issuing state and the facility 

address state are not the same.

18.1.5.21 If the license id root has the suffix “.5”, then the business operation is 

Wholesale Drug Distributor (C118411) and the license issuing state and the 

facility address state are not the same.

18.1.5.22 There are no other suffixes to the license id root.

18.1.5.23 If the territory code is “USA”, then the code system is 1.0.3166.1.2.3

18.1.5.24 If the territory is “USA”, then the issuing governing agency is specified with a 

DUNS number and name.

18.1.5.25 If the territory is not “USA”, then there is no governing agency specified.
18 Wholesale Drug Distributor/Third-Party Logistics Facility Report

184 

18.1.5.26 If the issuing governing agency is DEA, then the DUNS number is 004234790 

and the name “DEA”.

18.1.5.27 If the issuing governing agency is DEA then the license id root OID is 

1.3.6.1.4.1.32366.4.840.1. 

18.1.5.28 A DEA license is specified only with disciplinary actions.

18.1.5.29 There is one license per state, except a second state license can occur if there 

are disciplinary actions with it.

18.1.5.30 The combination of license number, license type (business operation), license 

issuing state and establishment address is not mentioned more than once in the 

same document.

18.1.6 Business Operation Qualifier 

<performance> 

 <actDefinition> 

 <code code="C118412" displayName="third-party logistics provider" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 <subjectOf> 

 <approval> 

 <code code="C123274" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="warehouses human prescription drug products"/> 

18.1.6.1 There may be one business operation qualifier if the business operation is thirdparty logistics provider (C118412). 

18.1.6.2 There is no id. 

18.1.6.3 Business operation qualifier is warehouses human prescription drug products 

(C123274). 

18.1.6.4 Display name matches the code.

18.1.6.5 Code system is 2.16.840.1.113883.3.26.1.1. 

18.1.6.6 Business operation is third-party logistics provider (C118412). 

18.1.7 Approval Disciplinary Action 

<approval> 

 <subjectOf> 

 <action> 

 <code code="disciplinary action code" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName=" disciplinary action name"/> 

 <effectiveTime value=“disciplinary action effective time”/> 
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185 

 <subjectOf> 

 <document> 

 <text mediaType="application/pdf"> 

 <reference value="suspension01.pdf"/> 

 </text> 

 </document> 

 </subjectOf> 

When action is “other” a brief text description of the nature of the action should be 

included: 

<approval> 

 <subjectOf> 

 <action> 

 <code code="C118472" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="other"/> 

 <text xsi:type=“ST”>brief description of nature of action</text> 

 <effectiveTime value=“disciplinary action effective time”/> 

 <subjectOf> 

 <document> 

 <text mediaType="application/pdf"> 

 <reference value="suspension01.pdf"/> 

 </text> 

 </document> 

 </subjectOf> 

Validation Procedures 

18.1.7.1 There is a disciplinary action code.

18.1.7.2 Code comes from the Approval action list.

18.1.7.3 Display name matches the code

18.1.7.4 Code system is 2.16.840.1.113883.3.26.1.1. 

18.1.7.5 If action is “other” (C118472), then there is a text element containing a brief 

description of the nature of the action: 

18.1.7.6 Text must be of xsi:type “ST” (plain text string).

18.1.7.7 Disciplinary action has an effective time.

18.1.7.8 The effective time value has at least the precision of day in the format 

YYYYMMDD.

18.1.7.9 Disciplinary actions are in chronological order, i.e., most recent action last. 

18.1.7.10 If the last disciplinary action is a suspension (C118406), then the license 

status code is suspended or completed. 
18 Wholesale Drug Distributor/Third-Party Logistics Facility Report

186 

18.1.7.11 If the last disciplinary action is a revocation (C118407, revoked), then the 

license status code is aborted. 

18.1.7.12 If the last disciplinary action is (re-)activation (C118408), then the license 

status code is active. 

18.1.7.13 If the last disciplinary action is a resolution (C118471, resolved), then the 

license status code is active or completed. 

18.1.7.14 If the last disciplinary action is “other” (C118472), then the license status 

code is active, completed, suspended or aborted. 

18.1.7.15 There may be one or more disciplinary action document references. 

18.1.7.16 Document reference has a text element with mediaType and reference.

18.1.7.17 Reference value is the file name for a valid document attachment.

18.1.7.18 Size of document attachment is less than 1 MB.

18.1.7.19 File name extension matches the media type“.pdf”.

18.1.7.20 All pdf files associated with the document must be actually referenced from 

that Wholesale Drug Distributors and Third-Party Logistics Facility Report

(75030-7) document. 

18.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 
SPL Implementation Guide with Validation Procedures v1

187 

19 40 CFR 180 TOLERANCE

19.1 Header

19.1.1 Document type 

<document> 

 code code="3565717" 

 codeSystem="2.16.840.1.113883.6.275.1" 

 displayName="40 CFR 180 Tolerance"/> 

Validation Procedures 

19.1.1.1 Document type is “40 CFR 180 TOLERANCE” (3565717). 

19.1.1.2 Code comes from the EPA Document type list

19.1.1.3 Code system is 2.16.840.1.113883.6.275.1 

19.1.1.4 Display name matches the code

19.1.1.5 If a document with the same set id has been previously submitted, then it is of 

the same type.

19.1.2 Author Information 

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="057944910"/> 

 <name>US Environmental Protection Agency</name> 

Validation Procedures 

19.1.2.1 There is an author. 

19.1.2.2 There are no other elements than id and name. 

19.1.2.3 There is one company name. 

19.1.2.4 The name matches the name in the Company Number List.

19.1.3 Docket Number 

The Docket Number is specified as follows: 
19 40 CFR 180 TOLERANCE

188 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="XFRM"> 

 <relatedDocument> 

 <id extension="docket number" root="docket number root OID"/> 

 </relatedDocument> 

 </relatedDocument> 

<component .../> 

</document> 

19.2 Body

19.2.1 Main Sections 

The main sections of the SPL document represent the first level paragraphs, (a), (b), 

(c), etc. of the section in the regulation. 

<section> 

 <id .../> 

 <code code="3145478" codeSystem="2.16.840.1.113883.6.275.1" 

 displayName="(a) General"/> 

 <title>(a) General.</title> 

 <text/> 

 <effectiveTime .../> 

Validation Procedures 

19.2.1.1 Section codes must come from list CFR_40_180_SECTION_PARAGRAPHS. 

19.2.1.2 Code system is 2.16.840.1.113883.6.275.1. 

19.2.1.3 Display name matches the code.

19.2.1.4 Title of the section matches the display name of the section code.

19.2.2 Sub-Section 

The first level sub sections of the SPL document represent the second level subparagraphs, (1), (2), (3), etc. in the regulation. 

<section> 

 ... 

 <component> 

 <section> 

 <id .../> 

 <title>(1)</title> 

 <text>...</text> 

 <effectiveTime .../> 
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Validation Procedures 

19.2.2.1 There is no section code. 

19.2.2.2 There is a title with an Arabic ordinal number in parentheses, e.g., “(1)”, “(2)”, 

etc.

19.2.3 Tolerance Specification

<section> 

 <component> 

 <section> 

 <subject> 

 <identifiedSubstance> 

 <id extension="..." root="2.16.840.1.113883.4.9"/> 

 <identifiedSubstance> 

 <code code="..." codeSystem="2.16.840.1.113883.4.9"/> 

 <name>...</name> 

 </identifiedSubstance> 

 <subjectOf> 

 <substanceSpecification> 

 <code code="40-CFR-..." 

 codeSystem="2.16.840.1.113883.3.149"/> 

 <component> 

 <observation moodCode="DEF"> 

 <code code="" displayName="" codeSystem=""/> 

 <analyte> 

 <identifiedSubstance> 

 <id extension="..." root="2.16.840.1.113883.4.9"/> 

 <identifiedSubstance> 

 <code code="..." 

 codeSystem="2.16.840.1.113883.4.9"/> 

 <name>...</name> 

 </identifiedSubstance> 

 </identifiedSubstance> 

 </analyte> 

 <referenceRange> 

 <observationCriterion> 

 <value xsi:type="IVL_PQ"> 

 <high value="" unit="[ppm]"/> 

 </value> 

 <subject> 

 <presentSubstance> 

 <presentSubstance> 

 <code code="..." 

 codeSystem="2.16.840.1.113883.6.275.1" 

 displayName="..."/> 

 <name>...</name> 

 </presentSubstance> 

 </presentSubstance> 

 </subject> 

 <subjectOf> 

 <approval> 

 <code code="3565718" 

 codeSystem="2.16.840.1.113883.6.275.1" 

 displayName="General Tolerance"/> 

 <text>text note about this tolerance</text> 

 <effectiveTime xsi:type="IVL_TS"> 

 <high value="expiration/revocation date"/> 

 </effectiveTime> 
19 40 CFR 180 TOLERANCE

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Validation Procedures

19.2.3.1 There is one identified substance with UNII code or EPA SRS tracking number.

19.2.3.2 There is one substance code.

19.2.3.3 Code system is 2.16.840.1.113883.4.9 (UNII) or 2.16.840.1.113883.6.275 (EPA

SRS tracking number).

19.2.3.4 Code and code system are the same as the parent element id’s extension and root 

respectively.

19.2.3.5 There is one substance name.

19.2.3.6 If the code system is UNII, then code comes from the substance name list.

19.2.3.7 Substance name matches code.

19.2.3.8 The substanceSpecification code is formed by using the fixed prefix “40-CFR-” 

followed by the section number present in document title.

19.2.3.9 Code system is 2.16.840.1.113883.3.149.

19.2.3.10 There is a code (Enforcement Analytical Method).

19.2.3.11 Code comes from the Enforcement Analytical Method list.

19.2.3.12 Display name matches the code.

19.2.3.13 There is are or more analytes, the substance(s) being measured.

19.2.3.14 Each analyte refers to one substance measured.

19.2.3.15 The rules for substance code and name are as in 19.2.3.2ff
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19.2.4 Tolerance Range and Commodity

 <substanceSpecification> 

 <component> 

 <observation moodCode="DEF"> 

 <referenceRange> 

 <observationCriterion> 

 <value xsi:type="IVL_PQ"> 

 <high value="" unit="[ppm]"/> 

 </value> 

 <interpretationCode code="N"/> 

 <subject> 

 <presentSubstance classCode="LOCE"> 

 <presentSubstance> 

 <code code="..." 

 codeSystem="2.16.840.1.113883.6.275.1" 

 displayName="..."/> 

 <name>...</name> 

 </presentSubstance> 

 </presentSubstance> 

 </subject> 

 <subjectOf> 

 <approval> 

 <code code="3565718" 

 codeSystem="2.16.840.1.113883.6.275.1" 

 displayName="General Tolerance"/> 

 <text>text note about this tolerance</text> 

 <effectiveTime xsi:type="IVL_TS"> 

 <high value="expration/revocation date"/> 

 </effectiveTime> 

19.2.4.1 There are one or more reference ranges (tolerances)

19.2.4.2 Reference ranges have a value

19.2.4.3 Value is of xsi type IVL_PQ

19.2.4.4 There is a high boundary with value and unit 

19.2.4.5 There is no low boundary 

19.2.4.6 High boundary value is a number. 

19.2.4.7 High boundary unit is “[ppm]”. 

19.2.4.8 There may be a commodity specified for the tolerance.

19.2.4.9 There is a tolerance commodity code.

19.2.4.10 Code system is 2.16.840.1.113883.6.275.1. 

19.2.4.11 Code comes from the Tolerance Commodity list. 

19.2.4.12 Display name matches code.
19 40 CFR 180 TOLERANCE

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19.2.4.13 There is an application type (approval).

19.2.4.14 There is an application type (approval) code.

19.2.4.15 Code system is 2.16.840.1.113883.6.275.1.

19.2.4.16 Code comes from the Application Type list.

19.2.4.17 Display name matches code.

19.2.4.18 There may be an expiration or revocation date.

19.2.4.19 Expiration or revocation date has a high boundary

19.2.4.20 Expiration or revocation date value has the format YYYYMMDD

19.2.4.21 Expiration or revocation date has no low boundary

19.2.4.22 There may be a text annotation.

19.2.5 Specific Sections and Sub-Sections

19.2.5.1 There is a section (a) General.

19.2.5.2 There is a section (b) Section 18 Emergency exemptions.

19.2.5.3 There is a section (c) Tolerances with regional restrictions.

19.2.5.4 There is a section (d) Indirect or inadvertent residues

19.2.5.5 There may be a section (e) Revoked tolerances subject to the channel of trade 

provisions

19.2.5.6 There may be a section (f) Import tolerances
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20 Indexing - Biologic or Drug Substance

This document communicates the FDA-preferred non-proprietary name (specified 

substance name) for the drug or biologic product associated with the application 

number included in this indexing SPL document. 

20.1 Header

20.1.1 Document Type 

<document> 

 <code code="77648-4" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Indexing - Biologic or Drug Substance"/> 

Validation Procedures 

20.1.1.1 The code for the document type is Indexing - Biologic or Drug Substance 

(77648-4).

20.1.1.2 If a document with the same set id has been previously submitted then it is of the 

same type.

20.1.2 Author 

The drug/biologic substance indexing is maintained by FDA: 

<document ...> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

Validation Procedures 

20.1.2.1 Author information for drug/biologic substance indexing is as one of the above. 

20.1.2.2 The author is Food and Drug Administration (FDA). 

20.1.2.3 There are no other author elements than id and name. 

20.1.3 Related Document 

The information in the drug/biologic substance indexing SPL file may be 

automatically linked to the SPL document submitted by the biologic or drug product’s 

distributor or manufacturer using the related document element which contains the set 
20 Indexing - Biologic or Drug Substance

194 

ID of the biologic or drug product’s SPL document. The related document SPL is 

specified using its setId as follows:

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="XCRPT”> 

 <relatedDocument> 

 <setId root="fe707775-a0ae-41b5-a744-28c41889fce8"/> 

 </relatedDocument> 

 </relatedDocument> 

Validation Procedures 

20.1.3.1 There may be a specified related document.

20.1.3.2 Type code attribute is as above.

20.1.3.3 There is no document id. 

20.1.3.4 There is a set id.

20.1.3.5 Set id is a GUID.

20.1.3.6 Related document’s set id is the set id of a drug listing document.

20.1.3.7 If a drug/biologic substance indexing file for the same related document’s set id 

has been previously submitted, then it is a prior version of this indexing 

document with the same set id. 

20.1.3.8 If a document with the same set id has been previously submitted, then it is 

associated with the same related document’s set id.

20.2 Body

<document> 

 <component> 

 <structuredBody> 

 <component><!-- old data element section --> 

 <section> 

 <id .../> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL indexing data elements section"/> 

 <effectiveTime> 

 <low value="old data effective start date"/> 

 <high value="old data effective end date"/> 

 </effectiveTime> 

 <subject ... old data ... /> 

 </section> 

 </component> 
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 <component><!-- new data element section --> 

 <section> 

 <id .../> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL indexing data elements section"/> 

 <effectiveTime> 

 <low value="new data effective star date"/> 

 </effectiveTime> 

 <subject ... new data ... /> 

 </section> 

Validation Procedures 

20.2.1.1 There is a document body. 

20.2.1.2 Document body contains one or two sections of type SPL Indexing Data 

Elements.

20.2.2 Index Data Element Section(s) in General 

<document> 

 <component> 

 <structuredBody> 

 <component> 

 <section> 

 <id .../> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL indexing data elements section"/> 

 <effectiveTime> 

 <low value="old data effective start date"/> 

 <high value="old data effective end date"/> 

 </effectiveTime> 

 <subject ... old data ... /> 

 </section> 

 </component> 

Validation Procedures 

20.2.2.1 Effective time has a low boundary indicating the period for the use of the 

specified substance name (FDA-preferred non-proprietary name) (data effective 

start date).

20.2.2.2 Data Elements section start date has at least the precision of day in the format 

YYYYMMDD.

20.2.2.3 Data Elements section end date has at least the precision of day in the format 

YYYYMMDD.

20.2.2.4 Data Elements section start date is before data elements section end date.

20.2.2.5 Data elements section contains information for a drug or biologic product. 
20 Indexing - Biologic or Drug Substance

196 

20.2.3 New (or only) Index Data Element Section 

<document> 

 <component> 

 <structuredBody> 

 <component ... old data element section, if any ... /> 

 <component><!-- new or only data element section --> 

 <section> 

 <id .../> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL indexing data elements section"/> 

 <effectiveTime> 

 <low value="new data effective star date"/> 

 </effectiveTime> 

 <subject ... new data ... /> 

 </section> 

Validation Procedures 

20.2.3.1 Data effective start date is same as the effective time in document information.

20.2.4 Old Index Data Element Section 

<document> 

 <component> 

 <structuredBody> 

 <component><!-- old data element section --> 

 <section> 

 <id .../> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL indexing data elements section"/> 

 <effectiveTime> 

 <low value="old data effective start date"/> 

 <high value="old data effective end date"/> 

 </effectiveTime> 

 <subject ... old data ... /> 

 </section> 

 </component> 

 <component ... new data element section ... /> 

Validation Procedures 

20.2.4.1 Old data elements section contains effective time high boundary (old data 

effective end date).

20.2.4.2 Old data element section comes before the new data element section.

20.2.4.3 Old SPL indexing data elements section has been submitted in the previous 

version of the document. 

20.2.4.4 New SPL indexing data elements section data should not match exactly to the 

old SPL indexing data elements section. 
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20.2.4.5 The end date of old data elements section is equal to the start date of new data 

elements section.

20.2.5 Biologic/Drug Product Information 

<section> 

 ... 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code=“61314-304” codeSystem=“2.16.840.1.113883.6.69”/> 

 <name>ZARXIO</name> 

 <ingredient classCode=“ACTIB”> 

 <ingredientSubstance> 

 <code code="PVI5M0M1GW" 

 codeSystem="2.16.840.1.113883.4.9"/> 

 <name>filgrastim-SNDZ</name> 

 </ingredientSubstance> 

 <subjectOf ... substance specification .../> 

 </ingredient> 

 </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <id extension="BLA125553" root="2.16.840.1.113883.3.150"/> 

 <code code="C73585" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="BLA"/> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

Validation Procedures 

20.2.5.1 There is a name, i.e., proprietary name of the product as used in product labeling 

(see subsection 3.2.1.17 and following). 

20.2.5.2 There is one active ingredient according to subsection 3.2.11. 

20.2.5.3 The strength is not specified for the active ingredient. 

20.2.5.4 The active moiety is not specified for the active ingredient.

20.2.5.5 Active ingredient is actually in the product, with the same basis of strength 

(classCode).

20.2.5.6 There is a marketing category and application number as per subsection 3.1.7. 

20.2.6 Specified Substance

<ingredient classCode=“ACTIB”/> 

 <ingredientSubstance .../> 

 <subjectOf> 

 <substanceSpecification> 

 <code code=" PVI5M0M1GW-SNDZ-1" codeSystem="2.16.840.1.113883.3.6277" 

 displayName="filgrastim-SNDZ"/> 
20 Indexing - Biologic or Drug Substance

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Validation Procedures

20.2.6.1 There is a specified substance code with code and code system.

20.2.6.2 Code system is 2.16.840.1.113883.3.6277.

20.2.6.3 There is a specified substance code display name.

20.2.6.4 Display name matches the specified substance code.
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21 Indexing - Warning Letter Alert

This document is to be used to connect the content of an FDA warning letter to the 

product SPL document of the product(s) described in the warning letter.

21.1 Header

21.1.1 Document Type 

<document> 

 <code code="77288-9" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Indexing - Warning Letter Alert "/> 

Validation Procedures 

21.1.1.1 The code for the document type is Indexing - Warning Letter Alert (77288-9). 

21.1.1.2 If a document with the same set id has been previously submitted then it is of the 

same type.

21.1.2 Author 

The Indexing – Warning Letter Alert file is maintained by FDA:

<document ...> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

Validation Procedures 

21.1.2.1 Author information for Indexing - Warning Letter is as one of the above. 

21.1.2.2 Author organization is FDA. 

21.1.2.3 There are no other author elements than id and name. 

21.1.3 Reference Labeling

The information in the warning letter alert indexing SPL file may be automatically linked 

to the SPL document submitted by the biologic or drug product’s distributor or 

manufacturer using the related document element which contains the set ID of the 

biologic or drug product’s SPL document. The SPL document containing the Reference 

Labeling is specified using its setId as follows:
21 Indexing - Warning Letter Alert

200 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="XCRPT”> 

 <relatedDocument> 

 <!-- <id root="2608fb41-083b-402b-94a0-0629fa484bb7"/> --> 

 <setId root="5dd66ebe-31b8-4319-9ff2-c37baaa138e6"/> 

 </relatedDocument> 

 </relatedDocument> 

Validation Procedures 

21.1.3.1 There is related document specified.

21.1.3.2 Type code attribute is as above.

21.1.3.3 There is no document id. 

21.1.3.4 There is a set id.

21.1.3.5 Set id is a GUID.

21.1.3.6 Related document set id is the set id of a drug listing document. 

21.1.3.7 If a warning letter alert indexing file for the same related document set id has 

been previously submitted, then it is a prior version of this indexing document 

with the same set id. 

21.1.3.8 If a document with the same set id has been previously submitted, then it is 

associated with the same related document set id.

21.2 Body

<document> <!-- SPL header material here --> 

 <component> 

 <structuredBody><!-- SPL body material here --> 

 <component> 

 <section> <!-- Product data element section --> 

 <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <subject> 

 <manufacturedProduct> 

 <!-- product data elements --> 

 </manufacturedProduct> 

 </subject> 

 </section> 

 </component> 

 <!-- Other content of labeling material --> 

 <component> 

 <!-- ... --> 
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21.2.1 Indexing Section 

Validation Procedures: 

21.2.1.1 If the document type is Indexing – Warning Letter Alert (77288-9) then the 

document contains one or more SPL Indexing Data Elements section as above.

21.2.1.2 Value of effective time is same as value of effective time in document 

information. 

21.2.2 Warning Letter Alert Data Element 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <name>proprietary name <suffix>suffix to name</suffix></name> 

 <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="tablet"/> 

 <asEntityWithGeneric> 

 <genericMedicine> 

 <name>non-proprietary name</name> 

 </genericMedicine> 

Validation Procedures:

21.2.2.1 There is a name, i.e., proprietary name of the product as used in product labeling 

SPL.

21.2.2.2 There is a generic medicine name as used in product labeling SPL.

21.2.2.3 There is a form code (dosage form).

21.2.2.4 Form code (dosage form) has the code system 2.16.840.1.113883.3.26.1.1. 

21.2.2.5 There are one or more strength amounts with a numerator and denominator for 

the active ingredient.

21.2.2.6 There is one or more product item codes. 

21.2.2.7 If the product item code is an NDC/NHRIC (i.e., if the root is 

“2.16.840.1.113883.6.69”), then the following procedures apply: 

21.2.2.8 Code (NDC/NHRIC product code) has two segments separated by a hyphen. 

21.2.2.9 The first segment (NDC/NHRIC labeler code) is numeric.

21.2.2.10 Segments (NDC/NHRIC product codes) follow the pattern of 4-4, 5-4 or 5-3. 
21 Indexing - Warning Letter Alert

202

21.2.3 Warning Letter Date Element

If the issue described in the warning letter has been resolved, there are date elements 

which can automatically inform the receiving system that the matter has been closed.

21.2.3.1 Effective time has a low boundary indicating the date the alert was issued.

21.2.3.2 Effective time may have a high boundary indicating when the issue described in 

the letter has been resolved.

21.2.3.3 Warning letter alert date has at least the precision of day in the format 

YYYYMMDD

21.2.3.4 Warning letter alert closure date has at least the precision of day in the format 

YYYYMMDD

21.2.3.5 Warning letter alert date is before reporting end date.
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22 [RESERVED]
23 Risk Evaluation and Mitigation Strategy (REMS)

204 

23 Risk Evaluation and Mitigation Strategy (REMS)

23.1 REMS Document

REMS are programs designed to ensure that the benefits of certain drugs outweigh 

their risks.

23.1.1 Document type 

All REMS documents have the following document type code. See Section 1 and 2 of 

the SPL Implementation Guide and Validation Procedures for general rules.

<document> 

 <id root=“Document Id (UUID)”/> 

 <code code="82351-8" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Risk Evaluation & Mitigation Strategies"/> 

 <title>Risk Evaluation and Mitigation Strategy (REMS)</title> 

 <effectiveTime value=“YYYYMMDD”/> 

 <setId root=“Document Set Id (UUID)” 

 <versionNumber value=“1”/> 

Validation Procedures

23.1.1.1 Document type is Risk Evaluation & Mitigation Strategies (82351-8) 

23.1.1.2 There is an author. 

23.1.1.3 If a document with the same set id has been previously submitted, then it is of 

the same type.

23.1.1.4 There is a title with the Risk Evaluation and Mitigation Strategy (REMS) 

Document [PROPRIETARY (established/proper name)] or 

[Established/Proper/Class Name] [Shared System] REMS. 

23.1.1.5 The effectiveTime should be the date of the most recent revision or modification 

of the REMS. 

23.1.2 REMS Author information 

<document ...> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="Sponsor DUNS"/> 

 <name>Sponsor Name</name> 

Validation Procedures 

23.1.2.1 There is one (author of document) 
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23.1.2.2 There is one id, the sponsor’s DUNS number, and name is as in Section 2.1.5. 

23.1.2.3 There is no other element besides id (the sponsor’s DUNS Number) and name. 

23.1.3 REMS Related Document

The REMS are provided for a drug or biologic product represented by the related 

document(s) SPL. As such, REMS append the related document(s) with more detail 

how to evaluate and manage risks regarding the product described in the related 

document(s). The related document(s) SPL document is referred to by its setId as 

follows: 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="SUBJ"> 

 <relatedDocument> 

 <setId root="97cf7820-4bfe-4caa-86f1-a97bfcf1917a"/> 

 </relatedDocument> 

 </relatedDocument> 

 <component .../> 

</document> 

Validation Procedures 

23.1.3.1 There is at least one related document specified.

23.1.3.2 Type code for the related document is as above.

23.1.3.3 There is a set id with root and no extension. 

23.1.3.4 Set id root is a GUID.

23.1.3.5 Related document set id is the set id of a product document of the specified type. 

23.1.3.6 If a REMS document file for the same related document set id has been 

previously submitted, then it is a prior version of this REMS document with the 

same set id. 

23.1.3.7 If a document with the same set id has been previously submitted, then it is 

associated with the same related document set id.

23.2 Body

23.2.1 REMS Sections and Subsections 

See subsection 2.1.1 of the FDA’s SPL Implementation Guide with Validation 

Procedures document for general section and subsection information. 
23 Risk Evaluation and Mitigation Strategy (REMS)

206

Validation Procedures

23.2.1.1 REMS document may have a REMS Timetable for Submission Assessments 

(82352-6) section.

23.2.1.2 REMS documents may have a REMS Administrative Information (87523-7) 

section.

23.2.1.3 If there is a REMS Administrative Information (87523-7) section, then the 

REMS document must have the following sections: REMS Goals (82349-2) and 

REMS Requirements (87524-5.)

23.2.1.4 If there is a REMS Administrative Information (87523-7) section, then the 

REMS document must not have the section REMS Summary (82347-6).

23.2.1.5 If there is a REMS Requirements (87524-5), then the REMS document must 

have the subsection REMS Applicant Requirements (87526-0.)

23.2.1.6 REMS documents that have REMS Requirements (87524-5) may have the 

subsection REMS Participant Requirements (87525-2.)

23.2.1.7 If there is no REMS Administrative Information (87523-7) section, then the 

REMS document may have the following sections:REMS Goals (82349-2), 

REMS Medication Guide (82598-4), REMS Elements to Assure Safe Use 

(82345-0), REMS Communication Plan (82344-3), and REMS Implementation 

System (82350-0).

23.2.1.8 If there is no REMS Administrative Information (87523-7) section, then the 

REMS document must not have the section REMS Requirements (87524-5.)

23.2.1.9 REMS documents with REMS Elements to Assure Safe Use (82345-0) may also

have REMS Summary (82347-6).

23.2.1.10 If the REMS document has any attachments, then the attachments are 

referenced from within the REMS Material (82346-8) section.

23.2.2 REMS Product

REMS product description contains less detail than the description of the product 

found in the related document SPL.

The beginning of the product data elements is as follows
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<component> 

 <section> 

 <id root="Section UUID"/> 

 <code code="48780-1" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

 <effectiveTime value="YYYYMMDD"/> 

 <subject> 

 <manufacturedProduct> 

The limited data elements for REMS products: 

<subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <name>proprietary name (except for shared system REMS)</name> 

 <asEntityWithGeneric> 

 <genericMedicine> 

 <name>non proprietary name</name> 

 </genericMedicine> 

 </asEntityWithGeneric> 

 </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <!-- marketing category and application number --> 

Validation Procedures 

23.2.2.1 Code, code system and display name are as above

23.2.2.2 There is an effective time with at least the precision of day in the format 

YYYYMMDD.

23.2.2.3 There are one or more products

23.2.2.4 There is no product item code. 

23.2.2.5 There is a generic name.

23.2.2.6 There is a proprietary name, except in a shared system REMS document.

23.2.2.7 There are no ingredients stated.

23.2.2.8 There is no package information. 

23.2.2.9 There is no route of administrations in REMS documents. 

23.2.2.10 There are no other product characteristics in REMS documents. 
23 Risk Evaluation and Mitigation Strategy (REMS)

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23.2.3 Marketing Category and Application Number 

The approval structure specifies in the <code> the marketing category under which 

the product is approved for marketing. Products marketed under an approved 

application have an application number in the <id extension> and application tracking 

system under <id root>. 

<manufacturedProduct> 

 <manufacturedProduct> ... </manufacturedProduct> 

 <subjectOf> 

 <approval> 

 <id extension="applicationnumber" 

 root="FDA document tracking system OID"/> 

 <code code="code for marketing category" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="display name"/> 

 <holder> 

 <role> 

 <playingOrganization> 

 <id root="1.3.6.1.4.1.519.1" 

 extension="Application Holder DUNS"/> 

 <name>Application Holder Name</name> 

 </playingOrganization> 

 </role> 

 </holder> 

 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

 </territory> 

 </territorialAuthority> 

 </author> 

Validation Procedures 

23.2.3.1 There is one marketing category for every product. 

23.2.3.2 There is a marketing category code. 

23.2.3.3 In a REMS SPL document, the marketing category is only ANDA (C73584), 

BLA (C73585), or NDA (C73594.) 

23.2.3.4 Display name matches the code

23.2.3.5 Code system is 2.16.840.1.113883.3.26.1.1 

23.2.3.6 Territorial authority is as above 

23.2.3.7 Marketing authorization holder is specified with DUNS number and name as 

above. 
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23.2.4 REMS Summary 

REMS with the section REMS Elements to Assure Safe Use (ETASU) typically 

include a REMS Summary. REMS with the section REMS Participant Requirements 

(87525-2) should not include a REMS Summary section. The REMS Summary is an 

overview of what stakeholders who participate in REMS with Elements to Assure 

Safe Use (ETASU), such as healthcare providers, patients, and distributors, are 

required to do under the REMS’ Elements to Assure Safe Use and Implementation 

System. The information in the summary is presented as a series of tables that show 

what clinical or administrative activity each stakeholder must carry out at each point 

in the medication use process. It is designed to be a reader-friendly summary of the 

REMS program requirements as well as a tool to facilitate the coding of REMS SPL 

data elements.

The REMS Summary includes all requirements in the REMS document that are 

directed towards stakeholders other than the application holder, but the summary 

should not include activities that REMS participants learn about or must be aware of 

but do not agree to undertake. For example, when filling out a form to enroll in the 

REMS, a prescriber may be asked to understand the importance of monitoring 

patients regularly. Unless they also agree to perform this monitoring, it would not be 

included in the summary. 

The summary is intended to be rendered as a series of tables as per the following 

template, including one table for each stakeholder who participates in the REMS. 

[Stakeholder Name]

[Protocol] [Requirement]

[Requirement]

[Protocol] [Requirement]

In the table above, each item in brackets represents a “summary item”, and should be 

replaced with appropriate text as follows: 

[Stakeholder] is replaced with a description of the participant to whom the REMS 

requirements apply, such as “Healthcare Providers who prescribe [drug]”. In most 

cases, simply identifying the role of the participant is sufficient, but in other cases the 

text will need to be more specific about the setting in which the drug is used, such as, 

“Healthcare Providers who prescribe the drug in outpatient settings” or “Closedsystem outpatient pharmacies that dispense.”

[Protocol] is replaced with the step of the medication use process (prescribing, 

dispensing, etc.) at which the requirement must be met, such as “Before the first 

prescription ” or “After discontinuation”. Requirements in the summary are 
23 Risk Evaluation and Mitigation Strategy (REMS)

210

organized by the timing at which they should be carried out – not when they are 

agreed to or acknowledged. 

[Requirement] is replaced with the clinical, administrative, or operational activities 

that the participant must carry out as part of the REMS, such as “Enroll the patient by 

completing and submitting the Patient Enrollment Form”. 

The language used in the requirement section is generally short and succinct, and no 

more than one or two sentences in length. To facilitate transmission of the text across 

the healthcare system, it should be in plain text and not use formatting such as bullets 

or indentations.

When the requirement mentions a material such as an enrollment form that is also 

attached or referenced in theREMS materials section, it includes a hyperlink to that 

material.

When a requirement applies only to a subset of patients (e.g., the requirement applies 

only to females of childbearing potential or a specific age group), the text is preceded 

by a description of the patient population followed by a colon, as in the following 

example: “For a female of childbearing potential: Counsel the patient on 

contraception” and “For patients younger than age 3: assess the patient’s response to 

the treatment”. 

Within a single step of the medication use process there can be more than one 

requirement. When the REMS specifies a certain order in which requirements are to 

be carried out, the summary lists the requirements in that order.

In certain cases multiple stakeholders may play a similar role in the medication use 

process (e.g., inpatient pharmacies and outpatient pharmacies that dispense the drug) 

but be subject to significantly different REMS requirements. In these cases the 

summary should include a separate table and stakeholder item for each of those 

stakeholders.

Validation Procedures

23.2.4.1 REMS with the section REMS Elements to Assure Safe Use (82345-0) may include 

a REMS Summary (82347-6.) 

23.2.4.2 REMS with REMS Participant Requirements (87525-2) should not include a REMS 

Summary section (82347-6).

23.2.5 REMS Data Elements

REMS Data Elements allow standardized terminology to be applied to the items in 

the REMS Summary (82347-6) and REMSParticipant Requirements (87525-2).All 
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items that appear in theREMS Summary and REMS Participant Requirements have 

corresponding data elements coded using the appropriate standardized term. If an 

application holder includes an item in their REMS Summary or REMS Participant 

Requirements to which no standardized term applies,the application holder should 

contact FDA for further assistance. REMS Data Elements allow standardized 

terminology to be applied to the items in the REMS Summary (82347-6) and 

REMSParticipant Requirements (87525-2). All items that appear in theREMS 

Summary and REMS Participant Requirements have corresponding data elements 

coded using the appropriate standardized term. If an application holder includes an 

item in their REMS Summary or REMS Participant Requirements to which no 

standardized term applies,the application holder should contact FDA for further 

assistance.

23.2.6 REMS Data Elements: Protocol 

REMS requirements are presented as the substance administration of the drug being a 

component of a REMS protocol described in the REMS Summary or REMS 

Participant Requirements which then has the requirements as other components of 

that protocol. The basic structure is as follows: 

<section> 

 ... 

 <subject2> 

 <substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/> 

 <protocol> 

 <code code="REMS Protocol Code" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="REMS Protocol Code Display Name"/> 

 <component> 

 <sequenceNumber value="REMS Requirement Sequence Number"/> 

 <requirement> 

Note that sequenceNumber under the <componentOf> element is fixed as value 2. 

This means that the substance administration of the drug under REMS is step 2 in the 

REMS summary protocol. Step 2 means that requirements can be meant to occur 

before (step 1), during (step 2), or after (step 3) the substance administration.

Substance administration is potentially a series of substance administrations 

depending on the type of protocol (protocol code). If the protocol guides the overall 

treatment, then substance administration represents the overall treatment beginning 

with the first prescription, and ending with the last dose. If the protocol guides a 

course of treatment, then the substance administration represents that course of 

treatment. This is coded in the protocol code. 
23 Risk Evaluation and Mitigation Strategy (REMS)

212 

Validation Procedures 

23.2.6.1 If there is a REMS Participant Requirements (87525-2) section or a REMS 

Summary (82347-6) section then there is a <protocol> data element within that 

section.

23.2.6.2 The REMS protocol is linked with a componentOf relationship with sequence 

number 2. 

23.2.6.3 REMS protocol has a code. 

23.2.6.4 REMS protocol code comes from the REMS Protocol Type list 

23.2.6.5 REMS protocol code system is 2.16.840.1.113883.3.26.1.1. 

23.2.6.6 REMS protocol display name matches the code. 

23.2.7 REMS Data Elements:Requirement 

The requirement is specified under a protocol as follows 

<substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/> 

 <protocol> 

 <component> 

 <sequenceNumber value="1"/> 

<requirement><!-- or <monitoringObservation> --> 

 <code code=“REMS Requirement Code” 

 displayName=”REMS Requirement Code” 

 codeSystem="2.16.840.1.113883.3.26.1.1"> 

 <originalText> 

 <reference value="#R003"/> 

 </originalText> 

 </code> 

 <effectiveTime> 

 <period value=“10” unit=“min”/> 

 </effectiveTime> 

 <participation typeCode="PPRF"> 

 <stakeholder> 

 <code code="C0SH01" displayName="prescriber" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </stakeholder> 

 </participation> 

 <subject> 

 <documentReference> 

 <id .../> 

The requirement code original text contains a reference linking to the content of the 

text which describes this requirement.
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The timing of the requirement is specified using the sequence number. Because the 

substance administration step is fixed at sequence number 2, if a requirement is to 

occur before the start of the drug step, the requirement’s sequence number is set to 1. 

To occur after the end of the drug step, the requirement’s sequence number is set to 3. 

To occur after the start of and along with the drug step, the requirement’s sequence 

number is set to 2 as well. 

The pause quantity element allows placing of requirement at a certain distance from 

the drug step. For instance, 

<substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/><!-- always fixed --> 

 <protocol> 

 <code ...step in the medication use process .../> 

 <component> 

 <sequenceNumber value="3"/> 

 <pauseQuantity value=“2” unit=“wk”/> 

 <requirement> 

means that the required action is to occur 2 weeks after the end of the step in the 

medication use process. And the following: 

<substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/><!-- always fixed --> 

 <protocol> 

 <code ...step in the medication use process .../> 

 <component> 

 <sequenceNumber value="2"/> 

 <pauseQuantity value=“1” unit=“h”/> 

 <requirement> 

means that the required action is to occur 1 hour after the start of the step in the 

medication use process, this often means “during” the medication process, e.g., 

during a treatment course, measure blood pressure. However, the pause quantity can 

delay this step a lot more, allowing us to say “2 months after the initiation of 

treatment”.

<substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/><!-- always fixed --> 

 <protocol> 

 <code ...step in the medication use process .../> 

 <component> 

 <sequenceNumber value="2"/> 

 <pauseQuantity value=“2” unit=“mo”/> 

 <requirement> 

The pause quantity always determines a delay between the previous step and this step. 

In the two examples above, the required action occurred after the start or the end of 

the step in the medication use process. When the required action is to occur before the 
23 Risk Evaluation and Mitigation Strategy (REMS)

214 

step in the medication use process, the pause quantity moves to the next step, the one 

with sequence number 2. 

<substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/><!-- always fixed --> 

 <pauseQuantity value=“1” unit=“h”/> 

 <protocol> 

 <code ...step in the medication use process .../> 

 <component> 

 <sequenceNumber value="1"/> 

 <requirement> 

To understand this, think about a simple 3 step action list: 

1. do preparatory work 

2. do the step in the medication use process 

3. do follow up work 

In the data model serialized into XML, we simply enter at number 2, the step in the 

medication use process. We then use sequence number 1 to represent preparatory 

work done before that step, and sequence number 3 to represent follow-up work done 

after that step.

2. do the step in the medication use process

1. do preparatory work 

3. do follow up work. 

However, the data model associates the pause with the step that is delayed. So for 

example:

1. do preparatory work 

2. one hour after previous step, do the step in the medication use 

process

3. two weeks after the previous step, do follow up work 

Additionally, a requirement can be said to repeat at a certain period duration. For 

example, we can say measure blood pressure 20 minutes after start of treatment and 

then every 10 minutes: 
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<substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/><!-- always fixed --> 

 <protocol> 

 <code ...treatment .../> 

 <component> 

 <sequenceNumber value="2"/> 

 <pauseQuantity value=“20” unit=“min”/> 

 <monitoringObservation> 

 <code ... blood pressure ..../> 

 <effectiveTime> 

 <period value=“10” unit=“min”/> 

Validation Procedures 

23.2.7.1 There is a REMS Requirement.

23.2.7.2 REMS requirement component has a sequence number with value 1, 2, or 3. 

23.2.7.3 If sequence number is 2 or 3, then there may be a pause quantity element. 

23.2.7.4 If sequence number is not 2 or 3, then there is no pause quantity element. 

23.2.7.5 If sequence number is 1, a pause quantity element may be under the 

componentOf parent element of the protocol ancestor element.

23.2.7.6 If sequence number is not 1, then there is no pause quantity element under the 

componentOf parent element of the protocol ancestor element. 

23.2.7.7 REMS Requirement has a code

23.2.7.8 REMS Requirement code system is 2.16.840.1.113883.3.26.1.1 

23.2.7.9 REMS Requirement code comes from the REMS Requirement list.

23.2.7.10 REMS Requirement display name matches the code.

23.2.7.11 Every text element in the REMS summary has an associated summary 

requirement code.

23.2.7.12 REMS Requirement code has an original text element with reference value.

23.2.7.13 Reference value links to the content ID of the section text of the section in 

which it is contained. 

23.2.7.14 Reference value can not be the same as that of a different requirement data 

element.
23 Risk Evaluation and Mitigation Strategy (REMS)

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23.2.7.15 There may be an <effectiveTime> with a <period> element to indicate 

repetition.

23.2.7.16 If there is an effectiveTime, then it has only a <period> child element.

23.2.7.17 REMS Requirements have a stakeholder 

23.2.7.18 Stakeholder participation type code is PPRF. 

23.2.7.19 Stakeholder has a code with code system 2.16.840.1.113883.3.26.1.1. 

23.2.7.20 Stakeholder code comes from the Stakeholder list.

23.2.7.21 Stakeholder display name matches the code.

23.2.7.22 REMS Requirements may have a document reference (also considered “topic” 

reference).

23.2.7.23 Document reference has an id with root and no extension. 

23.2.7.24 The value of the root matches an id of a document cited as a REMS Material 

(see Section 23.2.9) 

23.2.8 REMS Approval 

The Risk Evaluation and Mitigation Strategy (REMS) has a date of initial approval by 

the agency, which means, it is approved by the agency and this is represented by the 

following approval structure at the very first time a REMS substanceAdministration 

with protocol is mentioned in the REMS document. 

 <subject2> 

 <substanceAdministration> 

 <componentOf> 

 <sequenceNumber value="2"/> 

 <protocol> 

 ... 

 </protocol> 

 </componentOf> 

 <subjectOf> 

 <approval> 

 <code code="C128899" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="REMS Approval"/> 

 <effectiveTime> 

 <low value="Date of REMS Approval [YYYYMMDD]"/> 

 </effectiveTime> 
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 <author> 

 <territorialAuthority> 

 <territory> 

 <code code="USA" codeSystem="1.0.3166.1.2.3"/> 

 </territory> 

 </territorialAuthority> 

 </author> 

 </approval> 

 </subjectOf> 

 </substanceAdministration> 

 </subject2> 

Validation Procedures 

23.2.8.1 The first mention of a REMS protocol in the summary has a REMS approval 

structure (i.e. a subjectOf / approval element under the subject2 / 

substanceAdministration). 

23.2.8.2 Only the first mention of a REMS protocol in the summary has a REMS 

approval structure (i.e. only the first subject2 / substanceAdministration has a 

subjectOf / approval element).

23.2.8.3 There is a code for REMS Approval (C128899). 

23.2.8.4 Code system is 2.16.840.1.113883.3.26.1.1 

23.2.8.5 Display name matches the code.

23.2.8.6 There is an Initial REMS Program Approval Date (effectiveTime)

23.2.8.7 REMS Program Approval Date has at least the precision of day 

(YYYYMMDD.) 

23.2.9 REMS Material 

Materials referenced from the REMS document under the section of type "REMS 

Materials". There is a subject manufactured product with no code and only 

subjectOf/document elements each of which then contain one reference. 

For example, the material may be an attached PDF file to the REMS submission:
23 Risk Evaluation and Mitigation Strategy (REMS)

218 

 <section> 

 ... 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct/> 

 <subjectOf> 

 <document> 

 <id root="00000000-0000-0000-0000-000000000001"/> 

 <title>REMS SPL Pilot Counseling Material 

Placeholder<reference value="#T001"/> 

 </title> 

 <text mediaType=“application/pdf”> 

 <reference value="Drug X_2015-11-01_Counseling 

Material.pdf"/> 

 </text> 

 </document> 

 </subjectOf> 

The material may be a PDF file which is a form with instructions on where to send 

the form which was filled in:

 <subjectOf> 

 <document> 

 <id root="00000000-0000-0000-0000-000000000003"/> 

 <title>REMS SPL Pilot Dispenser Enrollment and 

Agreement Form Placeholder<reference value="#T003"/> 

 </title> 

 <text mediaType=“application/pdf”> 

 <reference value="drug-x-dispenser-encollmentform.pdf"/> 

 </text> 

 </document> 

 </subjectOf> 

Validation Procedures 

23.2.9.1 Each reference document has an id root 

23.2.9.2 Document reference has a title element with reference (title reference).

23.2.9.3 Title reference value is present in the content ID of the section text.

23.2.9.4 Document reference has a text element with mediaType and reference (text 

reference).

23.2.9.5 Text reference value is the file name for a valid document attachment.

23.2.9.6 File name extension matches the media type “.pdf”. 

23.2.9.7 Same file name cannot occur under a different document id and the same 

document id cannot be used with different file name. 

23.2.9.8 id (document id) does not match any other id across all sections, documents, or 

any id other than the id of the same document previously submitted. 
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23.2.10REMS Electronic Resource Information 

REMS may include references to electronic resources used to help carry out REMS 

activities. This information is captured using the document element and may be 

referenced within the REMS Summary using the documentReference data element 

</subjectOf>

REMS resources may be referenced as web content with an absolute URL reference 

with the “http://” or https://” protocol: 

<subjectOf> 

 <document> 

 <id root="00000000-0000-0000-0000-000000000004"/> 

 <title>REMS SPL Pilot Prescriber Enrollment and 

 Agreement Form Placeholder 

 <reference value="#T004"/> 

 </title> 

 <text> 

 <reference value="https://company.com/drug-x- 

 presciber-encollment.html"/> 

 </text> 

 </document> 

In cases where stakeholders are required to exchange data with the applicant, 

electronic data standards such as NCPDP telecommunications standards may be 

referenced. These consist of a special universal resource name (URN) which is 

formed with the prefix “urn:”. For example the URN 

“urn:NCPDP:D.0:P1:610674:000000000000-0000-0000-000000000005”, has five 

segments of text separated by colons following the prefix “urn:”. The segments are 

(1)the developer of the standard (e.g., “NCPDP”)

(2)the standard version (e.g. “D.0”), 

(3)the transaction (e.g. “P1”) 

(4)the destination address such as a BIN number (e.g., “610674”) 

(5)the id of a REMS material document which provides instructions for how 

to carry out the transaction. 

<subjectOf> 

 <document> 

 <id root="00000000-0000-0000-0000-000000000006"/> 

 <title>REMS SPL Pilot – NCPDP D0 - Patient Data </title> 

 <text> 

 <reference value="urn:NCPDP:D.0:P1:610674:00000000-0000-0000-0000 

 -000000000005"/> 

 </text> 

 </document> 

</subjectOf> 

Validation Procedures 

23.2.10.1 Each reference document has an id root. 
23 Risk Evaluation and Mitigation Strategy (REMS)

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23.2.10.2 Document reference has a title elementwith reference (title reference) .

23.2.10.3 Title reference value is present in the content ID of the section text.

23.2.10.4 Document reference has a text element with reference (text reference) but no 

mediaType.

23.2.10.5 Text reference value is a URI starting with a URI scheme (“http://” or “urn:”). 

23.2.10.6 If the text reference value begins with “urn:”, as for example in 

“urn:NCPDP:D.0:P1:610674:000000000000-0000-0000-0000-00000000”, then 

it is referencing an electronic data standard specification with five segments of 

text separated by colons; (1) the first segment after the prefix “urn:” being the 

organization that develops the standard (e.g., “NCPDP”),(2) the second segment 

being the standard version (e.g. “D.0”), (3) the third segment being the 

transaction (e.g. “P1”), (4) the fourth being destination address, such as a BIN 

number (e.g., “610674”), and (5) the fifth segment being the id of a REMS 

material document which provides instructions for how to carry out the 

transaction
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24 [RESERVED]
25 [RESERVED]

222

25 [RESERVED]
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26 [RESERVED]
27 [RESERVED]

224

27 [RESERVED]
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28 Blanket No Changes Certification of Product Listing Data

The following data elements are being collected in the Blanket No Chnanges 

Certification of Product Listing Data:

28.1 Header

28.1.1 Document type 

<document> 

 <code code="86445-4" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING"/> 

Validation Procedures 

28.1.1.1 Document type is “Blanket No Changes Certification of Product Listing” 

(86445-4).

28.1.1.2 The effective time year matches the current year.

28.1.1.3 There is no title

28.1.1.4 If a document with the same set id as the one in this file has been previously 

submitted, then the document type is the same. 

28.1.1.5 “Blanket No Changes Certification of Product Listing” documents are submitted 

during the time frame October 1st through December 31st of each year. 

28.1.2 Establishment Information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- manufacturer, no data here --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant, no data here --> 

 <assignedEntity> 

<assignedOrganization> <!-- establishment --> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <name>Establishment Name</name> 

Validation Procedures 

28.1.2.1 There are one or more establishment(s).

28.1.2.2 The establishment id (DUNS Number) has been submitted in a document of type 

Establishment Registration (51725-0) on or after October 1st of the previous 

year, or, if earlier, that Establishment Registration has been followed by a 
28 Blanket No Changes Certification of Product Listing Data

226 

document of type No Change Notification (53410-7) between October 1st and 

December 31st of the previous or the current year. 

28.1.2.3 Establishment has one id element, the DUNS number, and name as in Section 

2.1.5. 

28.1.2.4 The most recent Establishment Registration document for this establishment is 

not inactivated by an FDA Agency Initiated Compliance Action. 

28.1.3 NDC/ISBT Product Codes 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- manufacturer, no data here --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant, no data here --> 

 <assignedEntity> 

 <assignedOrganization> <!-- establishment --> 

<performance> 

 <actDefinition> 

 <product> 

 <manufacturedProduct classCode="MANU"> 

 <manufacturedMaterialKind> 

 <code code="NDC/ISBT Product Item Code" 

 codeSystem="2.16.840.1.113883.6.69"/> 

Validation Procedures 

28.1.3.1 Each establishment is linked to at least one NDC product code or ISBT code

referenced in this document 

28.1.3.2 Each NDC product code or ISBT code is linked to an establishment in this 

document. 

28.1.3.3 There are one or more establishments.

28.1.3.4 There is no act definition code. 

28.1.3.5 With the exception of the NDC product codes or ISBT codes for the inner 

components of kits (co-packaged products), there are one or more NDC product 

codes or ISBT codes.

28.1.3.6 Code system is 2.16.840.1.113883.6.69 (NDC) or 2.16.840.1.113883.6.18 

(ISBT).

28.1.3.7 Each product item code (NDC or ISBT) mentioned in this Blanket No Changes 

Certification of Product Listing (86445-4) file has been previously submitted in 

a drug/biological product listing file with a marketing status of “active”. 
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28.1.3.8 The current version of the previously submitted drug/biological product listing 

file for this NDC or ISBT product item code conforms to current validation 

procedures.

28.1.3.9 The NDC product code in a Blanket No Changes Certification of Product 

Listing (86445-4) may not have been previously included in an OTC Animal 

Drug Label (50577-6), OTC Type A Medicated Article Animal Drug Label

(50576-8), OTC Type B Medicated Feed Animal Drug Label (50574-3), OTC 

Type C Medicated Feed Animal Drug Label (50573-5), Prescription Animal 

Drug Label (50578-4), VFD Type A Medicated Article Animal Drug Label

(50575-0), VFD Type B Medicated Feed Animal Drug Label (50572-7), VFD 

Type C Medicated Feed Animal Drug Label (50571-9), or Animal Cells, Tissues, 

and Cell and Tissue Based Product Label (98075-5).

28.1.3.10 If the drug listing file associated with this NDC has been identified as having 

a listing deficiency, then it cannot be re-certified; the deficiency must be 

corrected first. Please contact eDRLS@fda.hhs.gov for additional details.

28.1.3.11 Each establishment DUNS Number associated with the product item code via 

its listing file has been submitted in a document of type ‘Establishment 

Registration’ (51725-0) on or after October 1st of the previous year, or, if 

earlier, that Establishment Registration has been followed by a document of type 

“No Change Notification” (53410-7) between October 1st and December 31st of 

the previous or the current year.

28.1.3.12 The NDC product code in this Blanket No Changes Certification of Product 

Listing (86445-4) file may not have been previously included in a document of 

type Bulk Ingredient (53409-9) with the marketing category of Bulk Ingredient 

for Animal Drug Compounding (C98252).

28.1.3.13 The current version of the previously submitted drug/biological product listing 

file for this NDC or ISBT product item code may not be implicated in an FDAInitiated Compliance Action – Drug Listing Inactivation with any open 

compliance actions.

28.1.3.14 The NDC or ISBT product item code has been listed as the top-level product 

in a listing file on or after January 1st of the previous year, or certified in a 

Blanket No Changes Certification of Product Listing (86445-4) file on or after 

October 1st but on or before December 31st of the previous year.

28.1.3.15 The product listing’s labeler DUNS number has been associated with the 

NDC labeler code segment of the product through the most recent labeler code 

request file.
28 Blanket No Changes Certification of Product Listing Data

228 

28.1.4 Authorized Agent 

<document> 

 <author> .../ 

 <legalAuthenticator> 

 <assignedEntity> 

 <representedOrganization> 

 <id extension="Authorized Agent's DUNS Number" 

 root="1.3.6.1.4.1.519.1"/> 

 <name>Authorized Agent Company Name</name> 

 <contactParty> 

 <telecom value="tel:+1-301-241-4445"/> 

 <telecom value="mailto:authorized.agents@usagents.com"/> 

 <contactPerson> 

 <name>Name of Authorized Agent's Contact Person</name> 

Validation Procedures 

28.1.4.1 There is one Authorized Agent 

28.1.4.2 There is one id, (the DUNS number), and name are as in Section 2.1.5. 

28.1.4.3 There is a contact party’s name as in Section 2.1.8. 

28.1.4.4 There is a telephone number and email address.

28.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 

28.2.1.1 The document body is empty 
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29 Human and Animal Salvaged Drug Products

29.1 Header

29.1.1 Document type 

The document type can be any of the human and animal or biologic drug products 

listing document types. The salvaged drug product file is not distinguished by a 

certain document type, but by the fact that salvage establishments and salvaged lot 

numbers are mentioned inside the document. 

<document> 

 <code code="50578-4" 

 displayName="PRESCRIPTION ANIMAL DRUG LABEL" 

 codeSystem="2.16.840.1.113883.6.1"/> 

Validation Procedures 

29.1.1.1 Document type is Bulk Ingredient (53409-9), Bulk Ingredient – Animal Drug

(81203-2), Cellular Therapy (60684-8), Drug for Further Processing (78744-0), 

Human OTC Drug Label (34390-5), Human Prescription Drug Label (34391-3), 

License Blood Intermediates/Paste Label (53407-3), Licensed Minimally 

Manipulated Cells Label (53408-1), Licensed Vaccine Bulk Intermediate Label

(53406-5), Non-Standardized Allergenic Label (53405-7), OTC Animal Drug 

Label (50577-6), OTC Type A Medicated Article Animal Drug Label (50576-8), 

OTC Type B Medicated Feed Animal Drug Label (50574-3), OTC Type C 

Medicated Feed Animal Drug Label (50573-5), Plasma Derivative (60683-0), 

Prescription Animal Drug Label (50578-4), Recombinant Deoxyribonucleic 

Acid Construct Label (78745-7), Intentional Animal Genomic Alteration Label 

(101437-2), Standardized Allergenic (60682-2), Vaccine Label (53404-0), VFD 

Type A Medicated Article Animal Drug Label (50575-0), VFD Type B 

Medicated Feed Animal Drug Label (50572-7), VFD Type C Medicated Feed 

Animal Drug Label (50571-9.), or Animal Cells, Tissues, and Cell and Tissue 

Based Product Label (98075-5).

29.1.1.2 The effective time year matches the current year.

29.1.1.3 There is title

29.1.1.4 If a document with the same set id as the one in this file has been previously 

submitted, then the document type is the same.
29 Human and Animal Salvaged Drug Products

230 

29.1.2 Establishment Information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- manufacturer, no data here --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant, no data here --> 

 <assignedEntity> 

<assignedOrganization> <!-- establishment --> 

 <id extension="DUNS Number" root="1.3.6.1.4.1.519.1"/> 

 <name>Establishment Name</name> 

Validation Procedures 

29.1.2.1 There is one establishment.

29.1.2.2 There is no other establishment. 

29.1.2.3 Establishment has one id element, the DUNS number, and name as in Section 

2.1.5. 

29.1.2.4 The establishment id (DUNS Number) has been submitted in a document of type 

“Establishment Registration” (51725-0) on or after October 1st of the previous 

year, or, if earlier, that Establishment Registration has been followed by a 

document of type “No Change Notification” (53410-7) between October 1st and 

December 31st of the previous or the current year. 

29.1.3 Business operation 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- manufacturer, no data here --> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant, no data here --> 

 <assignedEntity> 

 <assignedOrganization> <!-- establishment --> 

<performance> 

 <actDefinition> 

 <code code="C70827" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="SALVAGE"/> 

 </actDefinition> 

Validation Procedures 

29.1.3.1 There are one or more establishment operation details (performance act 

definitions). 

29.1.3.2 There is one business operation, salvage (C70827). 
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29.1.3.3 If have one salvage operation, then all operations are salvage. 

29.1.3.4 There is act definition code.

29.1.3.5 Code system is 2.16.840.1.113883.3.26.1.1 

29.1.3.6 Display name matches the code

29.2 Body

29.2.1.1 If the document type is Bulk Ingredient (53409-9), Bulk Ingredient – Animal Drug

(81203-2), Cellular Therapy (60684-8), Drug for Further Processing (78744-0), 

Human OTC Drug Label (34390-5), Human Prescription Drug Label (34391-3), 

License Blood Intermediates/Paste Label (53407-3), Licensed Minimally 

Manipulated Cells Label (53408-1), Licensed Vaccine Bulk Intermediate Label

(53406-5), Non-Standardized Allergenic Label (53405-7), OTC Animal Drug 

Label (50577-6), OTC Type A Medicated Article Animal Drug Label (50576-8), 

OTC Type B Medicated Feed Animal Drug Label (50574-3), OTC Type C 

Medicated Feed Animal Drug Label (50573-5), Plasma Derivative (60683-0), 

Prescription Animal Drug Label (50578-4), Recombinant Deoxyribonucleic Acid 

Construct Label (78745-7), Intentional Animal Genomic Alteration Label 

(101437-2), Standardized Allergenic (60682-2), Vaccine Label (53404-0), VFD 

Type A Medicated Article Animal Drug Label (50575-0), VFD Type B Medicated 

Feed Animal Drug Label (50572-7), VFD Type C Medicated Feed Animal Drug 

Label (50571-9), or Animal Cells, Tissues, and Cell and Tissue Based Product 

Label (98075-5), then the document contains data elements section as above. 

29.2.1.2 Value of effective time is same as value of effective time in document 

information. 

29.2.2 Lot number 

The label lot, or final container lot is the instance of the product, a portion of the fill 

lot that is portioned out into individual containers. 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance> 

 <member><!-- LABEL LOT --> 

 <memberProductInstance> 

 <id root="{Label Lot ID root OID}" extension="{Label Lot ID}"/> 

 <expirationTime> 

 <high value="20110417"/> 

 </expirationTime> 
29 Human and Animal Salvaged Drug Products

232

Validation Procedures

29.2.2.1 If the lot number is included Bulk Ingredient (53409-9), Bulk Ingredient –

Animal Drug (81203-2), Cellular Therapy (60684-8), Drug for Further 

Processing (78744-0), Human OTC Drug Label (34390-5), Human Prescription 

Drug Label (34391-3), License Blood Intermediates/Paste Label (53407-3), 

Licensed Minimally Manipulated Cells Label (53408-1), Licensed Vaccine Bulk 

Intermediate Label (53406-5), Non-Standardized Allergenic Label (53405-7), 

OTC Animal Drug Label (50577-6), OTC Type A Medicated Article Animal 

Drug Label (50576-8), OTC Type B Medicated Feed Animal Drug Label

(50574-3), OTC Type C Medicated Feed Animal Drug Label (50573-5), Plasma 

Derivative (60683-0), Prescription Animal Drug Label (50578-4), Recombinant 

Deoxyribonucleic Acid Construct Label (78745-7), Intentional Animal Genomic 

Alteration Label (101437-2), Standardized Allergenic (60682-2), Vaccine Label

(53404-0), VFD Type A Medicated Article Animal Drug Label (50575-0), VFD 

Type B Medicated Feed Animal Drug Label (50572-7), VFD Type C Medicated 

Feed Animal Drug Label (50571-9), or Animal Cells, Tissues, and Cell and 

Tissue Based Product Label (98075-5), then the only business operation is 

salvage (C70827.)

29.2.2.2 There is one or more label lot elements

29.2.2.3 The lot has an id, and the general rules for lot numbers apply.

29.2.2.4 There is an id extension with the reported alphanumeric lot number string

29.2.2.5 Lot number string can contain digits, upper case letters and the characters “-” 

and “/”.

29.2.2.6 There is a globally unique root OID

29.2.2.7 If the product item code is an NDC, then the globally unique root OID is formed 

by using the fixed prefix "1.3.6.1.4.1.32366.1.2.10." followed by the full 10-

digit NDC code represented as a number without dashes and with initial zeroes 

from the labeler code segment removed (e.g., "0001-0123-04" becomes 

1012304).

29.2.2.8 If the product item code is an ISBT 128 code, then the globally unique root OID 

is formed by using the fixed prefix “1.3.6.1.4.1.32366.1.2.13.” followed by a 

decimal number value for the ISBT 128 facility identification number followed 

by a period “.” and a decimal number value for the ISBT 128 product code, both 

interpreted as a base 36 number with the digits 0-9 and A-Z, with the letter digits 

having the value of 9 added to the ordinal letter position (A: 1 + 9 = 10, B = 2 + 

9 = 11, ..., Z = 26 + 9 = 35), and ending with a period “.” and the 3rd segment of 

the ISBT 128 package item code without leading zeroes; e.g., ISBT 128 product 

item code “W0123-E0404-03” with facility identification number “W0123” 
SPL Implementation Guide with Validation Procedures v1

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interpreted in base 36: W = 23 + 9 = 32 × 36 + 0) × 36) + 1) × 36 + 2) × 36 + 3 

= 53749083, and ISBT 128 product code “E0404” interpreted in base 36: E = 5 

+ 9 = 14 × 36 + 0) × 36 + 4 ) × 36 + 0) × 36 + 4 = 23519812, and 3rd segment 

“03” without zeroes, resulting in 

“1.3.6.1.4.1.32366.1.2.13.53749083.23519812.3”. 

29.2.2.9 There is an expiration time with a high boundary. 

29.2.2.10 Expiration time has at least the precision of month in the format YYYYMM

29.2.3 Container Data Elements 

<manufacturedProduct> 

 <instanceOfKind> 

 <productInstance> 

 <member><!-- LABEL LOT --> 

 <memberProductInstance> 

<asContent> 

 <quantity> 

 <numerator value="2" unit="mL"/> 

 <denominator value="1" unit="1"/> 

 </quantity> 

 <container> 

 <code code="1234-5678-01" codeSystem="2.16.840.1.113883.6.69"/> 

 <formCode code="C43169" displayName="bottle" 

 codeSystem="2.16.840.1.113883.3.26.1.1"/> 

 </container> 

Validation Procedures 

29.2.3.1 There is a container reference.

29.2.3.2 There is a quantity with a numerator and denominator. 

29.2.3.3 Numerator has a value greater than zero and a unit.

29.2.3.4 Numerator unit matches the dosing specification unit. 

29.2.3.5 Denominator has value 1 and either no unit or unit “1” 

29.2.3.6 The container form code and quantity is the same as the package of the product 

as described in the listing for the package NDC. 

29.2.3.7 There is a container packaged product code

29.2.3.8 Container packaged product item code is an NDC or based on ISBT-128.

29.2.3.9 There is a form code and display name 

29.2.3.10 Code system for form code is 2.16.840.1.113883.3.26.1.1 
29 Human and Animal Salvaged Drug Products

234

29.2.3.11 Display name matches form code
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30 FDA-Initiated Compliance Action – Drug Listing 

Inactivation 

30.1 Header

30.1.1 Document type 

<document> 

 <code code="89600-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="FDA-Initiated Compliance Action Drug Registration and 

Drug Listing Inactivation"/> 

Validation Procedures 

30.1.1.1 The document type is FDA-Initiated Compliance Action Drug Registration and 

Drug Listing Inactivation (89600-1) or FDA-Initiated Compliance Action – 

Drug Registration and Listing Inactivation - Animal Drug (99282-6). 

30.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type.

30.1.2 Author information 

FDA-initiated compliance action inactivation data is maintained by FDA:

<author> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

Validation Procedures 

30.1.2.1 Author information for drug listing inactivation is as above 

30.1.2.2 The author is FDA. 

30.1.2.3 There are no other author elements than id and name. 

30.1.3 Reference Document

The subject of a drug listing inactivation is a referenced listing SPL document. 
30 FDA-Initiated Compliance Action – Drug Listing Inactivation

236 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="SUBJ"> 

 <relatedDocument> 

 <setId root="Listing SPL Document Set Id (UUID)"/> 

 </relatedDocument> 

 </relatedDocument> 

 <component .../> 

</document> 

Validation Procedures 

30.1.3.1 There is one reference document specified.

30.1.3.2 Type code attribute is as above.

30.1.3.3 There is no document id 

30.1.3.4 There is a set id

30.1.3.5 Set id is a GUID

30.1.3.6 Reference document set id is the set id of a drug listing document. 

30.1.3.7 If a drug listing inactivation file for the same reference document’s set id has 

been previously submitted, then it is a prior version of this drug listing 

inactivation document with the same set id.

30.1.3.8 If a document with the same set id has been previously submitted, then it is 

associated with the same reference labeling set id.

30.1.3.9 If the document type is FDA-Initiated Compliance Action Drug Registration 

And Drug Listing Inactivation (89600-1), then the reference document set id is 

the set id of a human drug listing document. 

30.1.3.10 If the document type is FDA-Initiated Compliance Action Drug Registration 

And Drug Listing Inactivation - Animal Drug (99282-6), then the reference 

document set id is the set id of an animal drug listing document. 
SPL Implementation Guide with Validation Procedures v1

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30.2 Body

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="SUBJ"/> 

 <component> 

 <structuredBody> 

 <component> 

 <section> 

 <id root="c7b4aed4-55c3-4258-a655-352ccf023473"/> 

 <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL PRODUCT DATA ELEMENTS SECTION"/> 

 <title/> 

 <text/> 

 <effectiveTime value="20160405"/> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <asContent/> 

Validation Procedures 

30.2.1.1 There is one SPL Product Data Elements Section (48780-1.) 

30.2.1.2 There are no subsections. 

30.2.1.3 Validation procedures 2.2.1.2– 2.2.1.10 are applicable to FDA-Initiated 

Compliance Action Drug Registration and Drug Listing Inactivation (89600-1), 

and FDA-Initiated Compliance Action – Drug Registration and Listing 

Inactivation - Animal Drug (99282-6). 

30.2.1.4 There is no product code or any other product data elements except one flat list 

of packages (asContent elements)

30.2.2 Inactivated or Reactivated Listing’s NDC(s) 

<manufacturedProduct> 

 <asContent .../> 

 <asContent .../> 

 <asContent> 

 <containerPackagedProduct> 

 <code code="NDC Package Code" codeSystem="2.16.840.1.113883.6.69"/> 

Validation Procedures

30.2.2.1 There is at least one product package with item code. 

30.2.2.2 Package item code system is NDC (2.16.840.1.113883.6.69). 

30.2.2.3 NDC contains three segments divided by hyphens 
30 FDA-Initiated Compliance Action – Drug Listing Inactivation

238 

30.2.2.4 The NDC matches an NDC contained in the related listing document previously 

submitted, except if an effective time high value (reactivation date) is present for 

that NDC. 

30.2.2.5 The same NDC is not mentioned more than once. 

30.2.2.6 Product package has no other data elements than the package item code (NDC).

30.2.3 Compliance Action – Inactivation and Reactivation Status 

The compliance action is the inactivation of a listing of a particular package. It has an 

effective time with low (inactivation start) and high (inactivation end) date. If there is no 

inactivation end date, the inactivation is sustained, when there is an inactivation end date, 

the package is reactivated by FDA. 

Each package that is being inactivated is listed directly under the manufacturedProduct 

regardless of intermediary packages that may exist in the listing file.

<asContent> 

 <containerPackagedProduct> 

 <code code="NDC Package Code" codeSystem="2.16.840.1.113883.6.69"/> 

 </containerPackagedProduct> 

 <subjectOf> 

 <action> 

 <code code="C162847" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="Inactivated"/> 

 <effectiveTime> 

 <low value="20180115"/> 

 </effectiveTime> 

 </action> 

 </subjectOf> 

Validation Procedures 

30.2.3.1 There is one compliance action for each package.

30.2.3.2 Code is from the Regulatory Action list and display name matches the code. 

30.2.3.3 There is an effective time with at least a low value (inactivation date)

30.2.3.4 The effective time low (inactivation date) and high boundary (reactivation date) 

have at least the precision of day in the format YYYYMMDD 

30.2.3.5 If there is an effective time high value (reactivation date), then it is not less than 

the low value (inactivation date).

30.2.3.6 If there is an effective time high value (reactivation date), then it is not later than 

the document effective time.
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30.2.3.7 If inactivation ending date is not present in the previous version of the file then 

the product package can not be dropped from this file, except if the NDC has 

also been dropped from the most recent version of the referenced listing file.
31 FDA-Initiated Compliance Action – Establishment Registration Inac

240 

31 FDA-Initiated Compliance Action – Establishment 

Registration Inactivation

31.1 Header

31.1.1 Document type 

<document> 

 <code code="89600-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="FDA-Initiated Compliance Action Drug Registration and 

Drug Listing Inactivation"/> 

Validation Procedures 

31.1.1.1 The document type is FDA-Initiated Compliance Action Drug Registration and 

Drug Listing Inactivation (89600-1) or FDA-Initiated Compliance Action – 

Drug Registration and Listing Inactivation - Animal Drug (99282-6). 

31.1.1.2 If a document with the same set id has been previously submitted, then it is of 

the same type.

31.1.2 Author information 

FDA-initiated compliance action inactivation data is maintained by FDA:

<author> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

Validation Procedures 

31.1.2.1 Author information for establishment registration inactivation is as above. 

31.1.2.2 The author is FDA. 

31.1.2.3 There are no other author elements than id and name. 

31.1.3 Inactivated or Reactivated Establishments 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization> 
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<assignedEntity> <!-- establishment --> 

 <assignedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension="Establishment DUNS"/> 

 </assignedOrganization> 

 <subjectOf> 

 <characteristic> 

 <code code="C162847" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="Inactivated"/> 

 <effectiveTime .../> 

Validation Procedures 

31.1.3.1 There is an empty registrant level leading to the establishment.

31.1.3.2 The registrant level has no other element aside from the assignedEntity leading 

to the establishment

31.1.3.3 There are one or more establishments.

31.1.3.4 The establishment level has no other element aside from the 

assignedOrganization leading to the establishment and subjectOf to the 

compliance action (characterstic). 

31.1.3.5 Establishment is identified by one id, the DUNS Number. 

31.1.3.6 DUNS number has root 1.3.6.1.4.1.519.1 

31.1.3.7 DUNS number has a 9-digit extension

31.1.3.8 There is no other element besides the id for the DUNS Number. 

31.1.3.9 The establishment DUNS Number occurs only once in this file 

31.1.3.10 The establishment id (DUNS Number) has been submitted in a related 

document of type “Establishment Registration” (51725-0).

31.1.3.11 If the document type is FDA-Initiated Compliance Action Drug Registration 

And Drug Listing Inactivation (89600-1), then there is a business operation 

except Medicated Animal Feed Manufacture (C84635) and Outsourcing Animal 

Drug Compounding (C122061) in the previously submitted Establishment 

Registration (51725-0).

31.1.3.12 If the document type is FDA-Initiated Compliance Action Drug Registration 

And Drug Listing Inactivation - Animal Drug (99282-6), then there is a business 

operation Analysis (C25391), API Manufacture (C82401), Label (C84732), 

Manufacture (C43360), Medicated Animal Feed Manufacture (C84635) , 

Outsourcing Animal Drug Compounding (C122061), Pack (C84731), Particle 

Size Reduction (C84386), Positron Emission Tomography Drug Production
31 FDA-Initiated Compliance Action – Establishment Registration Inac

242 

(C91403), Relabel (C73607), Repack (C73606), Salvage (C70827), Sterilize

(C84382), or Transfill (C125710) in the previously submitted Establishment 

Registration (51725-0).

31.1.4 Compliance Action – Inactivation and Reactivation Status 

The compliance action is the inactivation of the registration of a particular establishment. 

It has an effective time with low (inactivation start) and high (inactivation end) date. If 

there is no inactivation end date, the inactivation is sustained, when there is an 

inactivation end date, the establishment is reactivated by FDA. 

<assignedEntity> <!-- establishment level --> 

 <assignedOrganization ... DUNS .../> 

 <subjectOf> 

 <characteristic> 

 <code code="C162847" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="Inactivated"/> 

 <effectiveTime> 

 <low value="20180115"/> 

 </effectiveTime> 

 </characteristic> 

 </subjectOf> 

Validation Procedures 

31.1.4.1 There is one compliance action for each establishment. 

31.1.4.2 Code is from the Regulatory Action list and display name matches the code. 

31.1.4.3 There is an effective time with at least a low value (inactivation date)

31.1.4.4 The effective time low (inactivation date) and high boundary (reactivation date) 

have at least the precision of day in the format YYYYMMDD 

31.1.4.5 If there is an effective time high value (reactivation date), then it is not less than 

the low value (inactivation date).

31.1.4.6 If there is an effective time high value (reactivation date), then it is not later than 

the document effective time.

31.1.5 Reference Document

The subject of an establishment registration inactivation is a referenced establishment 

registration SPL document. 
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<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="SUBJ"> 

 <relatedDocument> 

 <setId root="Listing SPL Document Set Id (UUID)"/> 

 </relatedDocument> 

 </relatedDocument> 

 <component .../> 

</document> 

Validation Procedures 

31.1.5.1 There is one reference document specified.

31.1.5.2 Type code attribute is subject (SUBJ). 

31.1.5.3 There is no document id 

31.1.5.4 There is a set id

31.1.5.5 Set id is a GUID

31.1.5.6 Reference document set id is the set id of an establishment registration 

document. 

31.1.5.7 If an establishment registration inactivation file for the same reference 

document’s set id has been previously submitted, then it is a prior version of this 

establishment registration inactivation document with the same set id.

31.1.5.8 If a document with the same set id has been previously submitted, then it is 

associated with the same reference labeling set id.

31.2 Body - Empty

Use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 
31 FDA-Initiated Compliance Action – Establishment Registration Inac

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Validation Procedures 

31.2.1.1 The document body is empty 
SPL Implementation Guide with Validation Procedures v1

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32 Drug Interactions Indexing 

32.1 Header

32.1.1 Document type 

<document> 

 <code code="93723-5" codeSystem="2.16.840.1.113883.6.1" 

 displayName="INDEXING - DRUG INTERACTIONS"/> 

Procedures

32.1.1.1 Document code is as above 

32.1.1.2 If a document with the same set id has been previously submitted then it is of 

the same type.

32.1.2 Author information 

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

32.1.2.1 Drug Interaction indexing content is maintained by FDA: 

32.1.2.2 Author information for drug interactions indexing is as one of the above 

32.1.3 Reference Labeling

The information about a Drug Interaction is derived from Reference Labeling. The 

Reference Labeling is found in the SPL document submitted by the innovator, or, if 

the innovator has stopped marketing the product, by a designated generic 

manufacturer. The SPL document containing the Reference Labeling is specified 

using its setId as follows: 

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="DRIV"> 

 <relatedDocument> 

 <setId root="20d9b74e-e3d8-4511-9df9-cec2087372fc"/> 

 </relatedDocument> 

 </relatedDocument> 

<component .../> 

</document> 
32 Drug Interactions Indexing

246 

Validation Procedures 

32.1.3.1 There is reference labeling specified.

32.1.3.2 Type code attribute is as above.

32.1.3.3 There is no document id 

32.1.3.4 There is a set id

32.1.3.5 Set id is a GUID

32.1.3.6 Reference labeling set id is the set id of a drug listing document. 

32.1.3.7 If a drug interactions indexing file for the same reference labeling set id has 

been previously submitted, then it is a prior version of this indexing document 

with the same set id. 

32.1.3.8 If a document with the same set id has been previously submitted, then it is 

associated with the same reference labeling set id.

32.2 SPL Body

<document> <!-- SPL header material --> 

 <component> 

 <structuredBody> <!-- SPL body material --> 

 <component> 

 <section> 

Validation Procedures 

32.2.1.1 The document body contains one or more sections 

32.2.2 Sections 

The interactions are grouped under the section headings where they have been 

mentioned. 

Validation Procedures 

<section> 

 <id root="dfe16f30-66af-4333-acd7-f6fa80d3d9cd"/> 

 <code code="34068-7" displayName="Dosage & Administration" 

 codeSystem="2.16.840.1.113883.6.1"/> 

 <effectiveTime value="20200529"/> 

 <subject2> 

 <substanceAdministration> 

 <subjectOf> 

 <issue> 
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32.2.2.1 Validation procedures for sections are as in Section 2.2.1 of this document. 

32.2.2.2 Each section has one or more interactions. 

32.2.3 Interaction 

An drug interaction is an issue related to the administration of the reference label drug 

document/section/subject2/substanceAdministration and then on the other hand is 

related to the administration of another substance (drug). So the pattern is: 

The labeled drug, which is the “consumable” of the first substance administration is 

only implicitly given by the product(s) which are the subject of the reference label. 

The administration of the “other” drug is also called the “contributing factor” to the 

issue with the labeled drug. 

<substanceAdministration> 

 <subjectOf> 

 <issue> 

 <code code="C54708" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="INTERACTION"/> 

 <risk .../> 

 <subject> 

 <substanceAdministrationCriterion> 

 <consumable .../> 

Validation Procedures

32.2.3.1 There is a code for interaction (C54708). 

32.2.3.2 Code system is 2.16.840.1.113883.3.26.1.1. 

32.2.3.3 Display name matches the code.

32.2.4 Contributing Factor 

In drug-drug interactions, the contributing factor is the administration of another 

drug. The other drug is “consumed” when administered, hence it is a “consumable”. 

The other drug can be specified as any “administrable material” usually on the level 

of a specific drug substance (ingredient), specified as a UNII code, or as a 

pharmacologic class (see Section 8).
32 Drug Interactions Indexing

248 

<issue> 

 <subject> 

 <substanceAdministrationCriterion> 

 <consumable> 

 <administrableMaterial> 

 <administrableMaterialKind> 

 <code code="80061L1WGD" displayName="CIMETIDINE" 

 codeSystem="2.16.840.1.113883.4.9"/> 

Validation Procedures 

32.2.4.1 There is a contributing factor, which is a substance administration. 

32.2.4.2 Contributing factor substance administration has a consumable 

32.2.4.3 Code system is UNII for specific drug substance or Med-RT or MeSH for 

pharmacologic class.

32.2.4.4 If code system is UNII, then the code comes from the UNII list.

32.2.4.5 The UNII display name matches the code.

32.2.4.6 If code system is MED-RT (2.16.840.1.113883.6.345), then the code comes 

from Med-RT subset for pharmacologic class indexing. 

32.2.4.7 Med-RT display name matches the code.

32.2.4.8 If code system is MeSH (2.16.840.1.113883.6.177), then the code comes from 

the MeSH subset for pharmacologic class indexing. 

32.2.4.9 MeSH display name matches the code.

32.2.5 Consequence (Risk) 

There are 3 kinds of interactions with regard to the consequence: 

1. Pharmacodynamic interactions, where the consequence is some adverse 

condition (medical problem). 

2. Pharmacokinetic interactions, where the consequence is a change in 

distribution, metabolization, or elimination. 

3. Unspecified interactions, where the exact consequence is not described. 

All three kinds of interactions have the same interaction/code, but are distinguished 

by the the kind of consequence observation code, if any. 
SPL Implementation Guide with Validation Procedures v1

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<issue> 

 <code code="C54708" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="INTERACTION"/> 

 <risk> 

 <consequenceObservation> 

 <code code="C54386" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="Pharmacokinetic effect"/> 

 <value code="C54355" displayName="INCREASED DRUG LEVEL" 

 codeSystem="2.16.840.1.113883.3.26.1.1" xsi:type="CE"/> 

Validation Procedures 

32.2.5.1 There may be one or more consequences or none at all (unspecified 

interactions). 

32.2.5.2 There is a code for type of consequence, either pharmacokinetic effect (C54386, 

with code system 2.16.840.1.113883.3.26.1.1) or medical problem (44100-6, of 

code syetem 2.16.840.1.113883.6.1). 

32.2.5.3 Display name for type of consequence matches the code 

32.2.5.4 There is a consequence observation value. 

32.2.5.5 Value xsi:type is as above

32.2.5.6 If consequence observation code is pharmacokinetic effect (C54386), then the 

consequence value comes from Pharmacokinetic Effect List.

32.2.5.7 Consequence value (Pharmacokinetic Effect) display name matches the code.

32.2.5.8 If consequence observation code is medical problem (44100-6), then the 

consequence value code system is SNOMED CT (2.16.840.1.113883.6.96). 

32.2.5.9 If consequence value code system is SNOMED CT (2.16.840.1.113883.6.96), 

then the code is 6 to 18 digits. 

32.2.5.10 If consequence value code system is SNOMED CT (2.16.840.1.113883.6.96), 

then the display name is the formal SNOMED CT name (fully specified name) 

with the parenthesis indicating the kind of concept (finding, disorder, event).
33 National Clinical Trials Number Indexing

250 

33 National Clinical Trials Number Indexing 

33.1 Header

33.1.1 Document type 

<document> 

 <code code="93372-1" codeSystem="2.16.840.1.113883.6.1" 

 displayName="INDEXING - NATIONAL CLINICAL TRIALS NUMBER"/> 

Procedures

33.1.1.1 Document code is as above 

33.1.1.2 If a document with the same set id has been previously submitted then it is of 

the same type.

33.1.2 Author information 

<author> 

 <time/> 

 <assignedEntity> 

 <representedOrganization> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Food and Drug Administration</name> 

33.1.2.1 NCT Indexing content is maintained by FDA: 

33.1.2.2 Author information for NCT Indexing is as one of the above 

33.1.3 Reference Labeling 

The NCT Indexing information is derived from Clinical Studies Section (34092-7) of 

Reference Labeling. The Reference Labeling is found in the SPL document submitted 

by the innovator, or, if the innovator has stopped marketing the product, by a 

designated generic manufacturer. The SPL document containing the Reference 

Labeling is specified using its setId as follows:

<document> 

 ... 

 <author .../> 

 <relatedDocument typeCode="DRIV"> 

 <relatedDocument> 

 <setId root="20d9b74e-e3d8-4511-9df9-cec2087372fc"/> 

 </relatedDocument> 

 </relatedDocument> 

<component .../> 

</document> 
SPL Implementation Guide with Validation Procedures v1

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Validation Procedures 

33.1.3.1 There is reference labeling specified.

33.1.3.2 There is no document id 

33.1.3.3 There is a set id

33.1.3.4 Set id is a GUID

33.1.3.5 Reference labeling set id is the set id of a drug listing document.

33.1.3.6 If a NCT indexing file for the same reference labeling set id has been previously 

submitted, then it is a prior version of this indexing document with the same set 

id. 

33.1.3.7 If a document with the same set id has been previously submitted, then it is 

associated with the same reference labeling set id.

33.2 Body

<section> 

 <id root=""/> 

 <code code="48779-3" codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL Indexing Data Elements Section"/> 

 <effectiveTime value=""/> 

33.2.1.1 If the document type is INDEXING - NATIONAL CLINICAL TRIALS NUMBER 

(93372-1), then the document contains one SPL Indexing Data Elements Section 

(48779-3) as above. 

33.2.1.2 Value of effective time is same as value of effective time in document 

information. 

33.2.2 National Clinical Trials Number 

<subject2> 

 <substanceAdministration> 

 <componentOf> 

 <protocol> 

 <id root="2.16.840.1.113883.3.1077" extension="NCT00005094"/> 

 </protocol> 

 </componentOf> 

 </substanceAdministration> 

</subject2> 

33.2.2.1 There is one or more NCT-References.

33.2.2.2 NCT Number has the prefix “NCT” followed by an 8-digit number. 
33 National Clinical Trials Number Indexing

252

33.2.2.3 NCT-Reference id root is 2.16.840.1.113883.3.1077.
SPL Implementation Guide with Validation Procedures v1

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34 [RESERVED]
35 Cosmetic Facility Registration

254 

35 Cosmetic Facility Registration 

Cosmetic facility registrations have only header information with a single registrant 

organization and a facility to be registered or whose registration is to be updated. 

Aside from the proper Cosmetic Facility Registration document type, four other 

document types can be used for cosmetic facility registration submissions, i.e., the 

Cosmetic Facility Registration - Amendment, Cosmetic Facility Registration - 

Abbreviated Renewal, Cosmetic Facility Registration - Cancellation, and Cosmetic 

Facility Registration - Biennial Renewal) 

Table 9: Cosmetic Facility Registration Document Types

Code Display Name

103573-2 Cosmetic Facility Registration Contains facility details, initial 

submission.

X8888-1 Cosmetic Facility Registration - Amendment Contains facility details, update 

for any changes.

X8888-2 Cosmetic Facility Registration - Abbreviated Renewal Does not contain facility details, 

for biennial reneval if there is no 

change.

X8888-3 Cosmetic Facility Registration - Cancellation Does not contain facility details

X8888-4 Cosmetic Facility Registration - Biennial Renewal Contains facility details, for 

biennial renewal that is not 

abbreviated.

35.1 Header

35.1.1 Document type 

<document> 

 <code code="103573-2" codeSystem="2.16.840.1.113883.6.1" 

 displayName="Cosmetic Facility Registration"/> 

Validation Procedures 

35.1.1.1 Document type is Cosmetic Facility Registration (103573-2), Cosmetic Facility 

Registration - Amendment (X8888-1), Cosmetic Facility Registration - 

Abbreviated Renewal (X8888-2), Cosmetic Facility Registration - Cancellation

(X8888-3), and Cosmetic Facility Registration - Biennial Renewal (X8888-4).

35.1.1.2 The effective time year matches the current year.

35.1.1.3 There is no title.

35.1.1.4 For a Cosmetic Facility Registration – Amendment (X8888-1), Cosmetic Facility 

Registration – Abbreviated Renewal (X8888-2), Cosmetic Facility Registration 

– Cancellation (X8888-3), and Cosmetic Facility Registration – Biennial 

Renewal (X8888-4), the set id in this document is the same set id included in a 
SPL Implementation Guide with Validation Procedures v1

255 

previously submitted Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration – Amendment (X8888-1), or Cosmetic Facility Registration 

– Biennial Renewal (X8888-4) with information about the facility.

35.1.1.5 If a document with the same set id as the one in this file has been previously 

submitted, then the document type of the previously submitted file is Cosmetic 

Facility Registration (103573-2), Cosmetic Facility Registration – Amendment

(X8888-1), or Cosmetic Facility Registration – Biennial Renewal (X8888-4). 

35.1.1.6 Cosmetic Facility Registration – Biennial Renewal (X8888-4) and Cosmetic 

Facility Registration – Abbreviated Renewal (X8888-2) documents are 

submitted every 2 years, i.e., the year of their submission is more than one year 

after the previous submission of any kind of Cosmetic Facility Registration 

document. 

35.1.2 Authorized Agent Information (Additional Contact)

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <!-- manufacturer, may be pass-trough --> 

 <assignedEntity> 

 <assignedOrganization> <!-- authorized agent --> 

 <id root="1.3.6.1.4.1.519.1" extension=""/> 

 <name>Cosmetic Company</name> 

 <contactParty> 

Validation Procedures 

35.1.2.1 If the document type is Cosmetic Facility Registration - Abbreviated Renewal

(X8888-2), and Cosmetic Facility Registration - Cancellation (X8888-3), then 

there is no authorized agent (additional contact).

35.1.2.2 If the document type is Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration - Amendment (X8888-1), or Cosmetic Facility Registration 

– Biennial Renewal (X8888-4) , then there may be authorized agent information 

(additional contact). 

35.1.2.3 [RESERVED] 

35.1.2.4 [RESERVED]

35.1.2.5 [RESERVED]

35.1.2.6 There may be one contact party (additional contact) as in Section 2.1.8. 

35.1.2.7 Cosmetic Facility Registration has no labeler information.
35 Cosmetic Facility Registration

256 

35.1.3 Submitter Name and Signature (Legal Authenticator) 

The authorized individual may sign for the responsible organization as follows: 

<document> 

 <author .../> 

 <legalAuthenticator> 

 <noteText>The data and information in this submission have been 

reviewed and, to the best of my knowledge, are certified to be true and 

accurate. I agree to report changes to this information and renew as 

required under section 607 of the Federal Food, Drug, and Cosmetic 

Act.</noteText> 

 <time value= “”/> 

 <signatureText mediaType=“text/plain”>P. Bauer</signatureText> 

 <assignedEntity> 

 <assignedPerson> 

 <name>Peter Bauer</name> 

 </assignedPerson> 

 <representedOrganization/> 

35.1.3.1 There may be a signature (legalAuthenticator).

35.1.3.2 If present, the signature may contains a signing statement (noteText) exactly as 

above. 

35.1.3.3 If present, there is one signatureText element. 

35.1.3.4 If present, the signatureText has mediaType “text/plain” and the electronic 

signature in text content. 

35.1.3.5 If present, the signature contains one assigned person (the signing person). 

35.1.3.6 If present, assigned person has a name 

35.1.3.7 If present, assigned person has only a name, no other element. 

35.1.3.8 If present, the signature contains an empty representedOrganization element (the 

signer signs for the responsible organization). 

35.1.3.9 There is an time with at least the precision of day in the format YYYYMMDD

35.1.4 Facility Information 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

 <assignedEntity> 
SPL Implementation Guide with Validation Procedures v1

257 

<assignedOrganization><!-- facility --> 

 <id extension="100000001" root="1.3.6.1.4.1.519.1"/> 

 <id extension="123456" root="2.16.840.1.113883.4.82"/> 

 <name>Facility Name</name> 

 <addr> 

 <streetAddressLine>123 Burl Road</streetAddressLine> 

 <city>Dublin</city> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

 <contactParty .../> 

 <assignedEntity ... US AGENT ... /> 

 <assignedEntity1 ... Parent Company .../> 

Validation Procedures 

35.1.4.1 If the document type is Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration -- Amendment (X8888-1), or Cosmetic Facility 

Registration – Biennial Renewal (X8888-4), then there is one facility. 

35.1.4.2 If the document type is Cosmetic Facility Registration - Abbreviated Renewal

(X8888-2) or Cosmetic Facility Registration - Cancellation (X8888-3), then 

there is no facility information.

35.1.4.3 Facility has one name and one or two id elements, with the first id, the DUNS 

number as in Section 2.1.5 but optional. 

35.1.4.4 There is a second id (or if there is no DUNS number, the first id), the FEI with 

root 2.16.840.1.113883.4.82 and 7- or 10-digit extension. 

35.1.4.5 If present, the DUNS number along with the facility name and address 

information match the DUNS number record in the Dun and Bradstreet 

database.

35.1.4.6 The FEI number along with the facility name and address information match the 

FEI number record previously assigned by the FDA. 

35.1.4.7 Each facility has an address as in Section 2.1.6. 

35.1.4.8 There is one contact party as in Section 2.1.8. 

35.1.4.9 There is no assigned entity other than for US Agent. 
35 Cosmetic Facility Registration

258 

35.1.5 Facility US Agent 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

 <assignedOrganization><!-- facility --> 

 <addr> 

 <country code="IRL" 

 codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

<assignedEntity> 

 <assignedOrganization><!-- facility US agent --> 

 <name>Simmons Reps Company</name> 

 <telecom value="tel:+1-800-555-1212"/> 

 <telecom value="mailto:contact@USagent.com"/> 

 </assignedOrganization> 

 <performance> 

 <actDefinition> 

 <code code="C73330" codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="United States agent"/> 

Validation Procedures 

35.1.5.1 If the country for the facility is not “USA”, then there is one US agent. 

35.1.5.2 US agent element has code, code system and display name are as above.

35.1.5.3 If the country for the facility is "USA", then there is no US agent. 

35.1.5.4 US agent has a US telephone number (see 2.1.7.3 and following). 

35.1.5.5 US agent has an e-mail address which is “N/A” if there is no email. 

35.1.5.6 There is at most one US Agent. 

35.1.6 Parent Company 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

 <assignedEntity> 

 <assignedOrganization><!-- facility --> 

 ... 

<assignedEntity1> 

 <representedOrganization><!-- parent company --> 

 <name>Parent Company Name</name> 

 </representedOrganization> 
SPL Implementation Guide with Validation Procedures v1

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35.1.6.1 If there is a parent company, there is just one name. 

35.1.7 Small Business Designation 

To indicate that the facility is a small business (except those which are not exempt 

per section 612b of the FD&C Act), include the following characteristic element:

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

 <assignedOrganization .../><!-- facility --> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLSMALLBUSINESS" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="BL" value="true"/> 

 </characteristic> 

</subjectOf> 

35.1.7.1 Code and code system is as above (for SPLSMALLBUSINESS) 

35.1.7.2 There is a Boolean value as above. 

35.1.7.3 Value is “true”; to indicate not a small business omit the characteristic.

35.1.8 Facility Operation 

Validation Procedures 

35.1.8.1 There are no facility operation details (performance act definitions).

35.2 Body

If no cosmetic product listing information is included, use an empty document body: 

<document> 

 <component> 

 <structuredBody/> 

or 

<document> 

 <component> 

 <nonXMLBody> 

 <text/> 
35 Cosmetic Facility Registration

260 

If cosmetic product information is included there is a document body with the product 

data element section:

<document> 

 <component> 

 <section> 

 <id root="e13a985b-f706-a5c8-e8ef-73891eb1c697"/> 

 <code code="48780-1" 

 codeSystem="2.16.840.1.113883.6.1" 

 displayName="SPL product data elements section"/> 

Validation Procedures 

35.2.1.1 If the document is a Cosmetic Facility Registration – Abbreviated Renewal

(X8888-2), Cosmetic Facility Registration – Cancellation (X8888-3), then the 

document body is empty 

35.2.1.2 If the document is a Cosmetic Facility Registration (103573-2), Cosmetic 

Facility Registration - Amendment (X8888-1), or Cosmetic Facility Registration 

– Biennial Renewal (X8888-4), then there is a document body. 

35.2.1.3 The document body contains one section

35.2.1.4 The one section contains the product data elements 

35.2.2 Cosmetic Product 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="53-000000-000001" 

 codeSystem="2.16.840.1.113883.3.9848"/> 

 <name>Juvenia Soft</name> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="01B" codeSystem="2.16.840.1.113883.6.345" 

 displayName="Baby products – Lotions, oils, powders, and creams"/> 

The cosmetic listing number is included in any update after it has been assigned 

subsequent to an initial cosmetic product listing submission.

Validation Procedures 

35.2.2.1 There is a name, i.e., the brand name under which the cosmetic product is sold.

35.2.2.2 Markings such as ®, or TM should not be included. 

35.2.2.3 There are one or more cosmetic product category codes (asSpecializedKind 

element) with a code (see Section 3.4.3). 
SPL Implementation Guide with Validation Procedures v1

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35.2.2.4 There are no other elements besides item code, name and cosmetic product type

(asSpecializedKind)

35.2.3 Responsible Person (Organization) 

<manufacturedProduct> 

 <manufacturedProduct> 

 ... name, cosmetic product type ... 

 </manufacturedProduct> 

 <manufacturerOrganization><!-- responsible person --> 

 <name>Responsible Person (Organization) Name</name> 

 </manufacturerOrganization> 

Validation Procedures 

35.2.3.1 There is one responsible person (organization). 

35.2.3.2 Responsible person (organization) has one name.

35.2.3.3 There are no other elements besides the name.
36 Cosmetic Product Listing

262 

36 Cosmetic Product Listing

Cosmetic product listings conform to 21 U.S.C. Sec. 607 as amended by the 

Modernization of Cosmetics Regulation Act of 2022. Three document types can be 

used for Cosmetic product listing, i.e., the Cosmetic, Cosmetic - Update , Cosmetic - 

Abbreviated Renewal. 

Table 10: Cosmetic Listing Document Types

Code Display Name

103572-4 Cosmetic Product Listing Contains cosmetic product details, initial submission.

X8888-5 Cosmetic – Update Contains cosmetic product details, update for any 

changes.

X8888-6 Cosmetic – Abbreviated Renewal Does not contains cosmetic product details

36.1 Header

36.1.1 Document Type 

36.1.1.1 Document types is Cosmetic Product Listing (103572-4), Cosmetic – Update

(X8888-5), or Cosmetic – Abbreviated Renewal (X8888-6). 

36.1.1.2 The effective time year matches the current year.

36.1.1.3 There is no title.

36.1.1.4 For a Cosmetic – Update (X8888-5), Cosmetic – Abbreviated Renewal (X8888-

6), the set id in this document is the same set id included in a previously 

submitted document of type Cosmetic Product Listing (103572-4) or Cosmetic – 

Update (X8888-5). 

36.1.1.5 If a document with the same set id as the one in this file has been previously 

submitted, then the document type of the previously submitted file is Cosmetic

Product Listing (103572-4) or or Cosmetic – Update (X8888-5).

36.1.2 Labeler (“responsible person” as per label) 

<document> 

 <code code="..." codeSystem="2.16.840.1.113883.6.1" 

 displayName="..."/> 

 <author> 

<assignedEntity> 

 <representedOrganization> 

 <id extension="100000007" root="1.3.6.1.4.1.519.1"/> 

 <name>Acme cosmetics company</name> 

 <telecom value=“tel:+1-800-123-4567”/> 

 <contactParty> 
SPL Implementation Guide with Validation Procedures v1

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 <addr> 

 <streetAddressLine>1625 29th street</streetAddressLine> 

 <city>Camden</city> 

 <state>NJ</state> <postalCode>08101</postalCode> 

 <country code="USA" codeSystem="1.0.3166.1.2.3">USA</country> 

 </addr> 

 <telecom value="tel:+1-800-555-1213;ext=112"/> 

 <telecom value="mailto:Bob.Jones@acme.com"/> 

 <contactPerson> 

 <name>Bob Jones</name> 

 </contactPerson> 

 </contactParty> 

Validation Procedures 

36.1.2.1 There is one labeler (“responsible person”), except if the document type is 

Cosmetic – Abbreviated Renewal (X8888-6). 

36.1.2.2 Responsible person has one name and may have one id element, the DUNS 

number as in Section 2.1.5 but optional. 

36.1.2.3 Responsible person has one telephone number (see 2.1.7.3 and following). 

36.1.2.4 There may be one contact party (additional contact) as in Section 2.1.8. 

36.1.2.5 Responsible person may have a parent company as per Section 35.1.6

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

<assignedEntity1> 

 <representedOrganization><!-- parent company --> 

 <name>Parent Company Name</name> 

 </representedOrganization> 

36.1.2.6 There is no other element besides id (the labeler’s DUNS Number), name, 

telephone number, parent company (assignedEntity1), contact party, and 

registrant (see next section). 

36.1.3 Registrant 

Details about the responsible person (organization) and its function as manufacturer, 

packer, or distributor, and other facilities where the product is manufactured or 

processed are reached through the otherwise empty “registrant” level: 
36 Cosmetic Product Listing

264 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization> 

Validation Procedures 

36.1.3.1 There is one assignedEntity/assignedOrganization element. 

36.1.3.2 There is no other element besides facilities. 

36.1.4 Responsible person further details 

These include the type of business (manufacturer, packer, or distributor) and whether 

it is a small business.

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- labeler --> 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

<assignedEntity><!-- responsible person details --> 

 <assignedOrganization/> 

 <subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLSMALLBUSINESS" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="BL" value="true"/> 

 </characteristic> 

 </subjectOf> 

 <performance> 

 <actDefinition> 

 <code code="C43360" 

 codeSystem="2.16.840.1.113883.3.26.1.1" 

 displayName="manufacture"/> 

 </actDefinition> 

 <performance> 

</assignedEntity> 

Validation Procedures 

36.1.4.1 If further details about the responsible person are provided, then they are in the 

first assignedEntity element under the registrant level, with an empty 

assignedOrganization element. 

36.1.4.2 There may be a small business designation as in Section 35.1.7

36.1.4.3 There may be a performance actDefinition code as above.
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36.1.4.4 Code system is 2.16.840.1.113883.3.26.1.1 

36.1.4.5 Code is manufacture (C43360), pack (C84731), or distribute (C201565) 

36.1.4.6 Display name matches the code.

36.1.4.7 Responsible person further details has no operation product link. 

36.1.4.8 Responsible person further details has at least a small business indicator or a 

type of business code. 

36.1.4.9 Responsible person further details has no other information besides a small 

business indicator or a type of business code. 

36.1.5 Facility information 

All other assignedEntity elements under the registrant are facilities, with only an id 

(the FEI) if the facility was required to be registered:

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- labeler --> 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

<assignedEntity> 

 <assignedOrganization><!-- Facility --> 

 <id extension="123456" root="2.16.840.1.113883.4.82"/> 

 </assignedOrganization> 

or with a name or address or FEI if, as a small business, the facility was not required 

for being registered and has not been registered: 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- labeler --> 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

<assignedEntity> 

 <assignedOrganization><!-- Facility --> 

 <name>Nimble Cosmetics Maker</name> 

 <addr> 

 <streetAddressLine>123 Burl Road</streetAddressLine> 

 <city>Dublin</city> 

 <country code="IRL" codeSystem="1.0.3166.1.2.3">Ireland</country> 

 </addr> 

 </assignedOrganization> 

Facilities may also have a small business designation:
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<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization> 

 <assignedEntity> 

 <assignedOrganization> <!-- registrant --> 

 <assignedEntity> 

 <assignedOrganization .../><!-- facility --> 

<subjectOf> 

 <characteristic classCode="OBS"> 

 <code code="SPLSMALLBUSINESS" 

 codeSystem="2.16.840.1.113883.1.11.19255"/> 

 <value xsi:type="BL" value="true"/> 

 </characteristic> 

</subjectOf> 

Validation Procedures 

36.1.5.1 There are one or more facilities. 

36.1.5.2 Facility may have a small business designation (except those which are not 

exempt per section 612b of the FD&C Act) as in 35.1.7. 

36.1.5.3 Facility may have an id, the FEI only. 

36.1.5.4 The id is a FEI, with root 2.16.840.1.113883.4.82 and 7- or 10-digit extension. 

36.1.5.5 The id (FEI) is not used for any other facilities in the file.

36.1.5.6 If the facility has no small business designation then there is an FEI. 

36.1.5.7 If the facility has a small business designation then there may be an FEI. 

36.1.5.8 If there is an id (FEI), then there may be a name or address.

36.1.5.9 If the facility is a small business (except those which are not exempt per section 

612b of the FD&C Act) and there is no FEI, then there may be a name or 

address.

36.1.5.10 If the facility has a small business designation, then the facility may have a 

name .

36.1.5.11 If the facility has a small business designation, then the facility may have an 

address as in Section 2.1.6 . 

36.1.5.12 Facility (“assignedOrganization”) has no other element besides id (the FEI

Number) or name and address. 
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36.1.6 Facility Product Link 

The following example shows how the facilities are linked to particular products. It is 

done by replicating the business operation (actDefinition) elements, and connecting 

each with one product as shown below: 

<document> 

 <author> 

 <assignedEntity> 

 <representedOrganization><!-- labeler --> 

 <assignedEntity> 

 <assignedOrganization><!-- registrant --> 

<assignedEntity> 

 <assignedOrganization><!-- Facility --> 

 .. id or name and addr ... 

 </assignedOrganization> 

<performance><actDefinition> 

 <product> 

The reference to the product occurs either by listing number if that has been assigned 

(i.e. if the product data elements in this document already contain the listing number): 

<product> 

 <manufacturedProduct classCode=“MANU”> 

 <manufacturedMaterialKind> 

 <code code="53-XXXXXX-XXXXXX" 

 codeSystem="2.16.840.1.113883.3.9848"/> 

 </manufacturedMaterialKind> 

 </manufacturedProduct> 

</product> 

or if the product listing number has not yet been assigned, then the reference is made 

by name for the cosmetic product, as such name appears on the label: 

<actDefinition> 

 <product> 

 <manufacturedProduct classCode=“MANU”> 

 <manufacturedMaterialKind> 

 <code/> 

 <name>Baby Shampoo</name> 

 </manufacturedMaterialKind> 

 </manufacturedProduct> 

 </product> 

Note that the schema still requires an empty code element.
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Validation Procedures 

36.1.6.1 There are one or more performance/actDefinition elements.

36.1.6.2 The performance/actDefinition element has one product reference.

36.1.6.3 There is either a Cosmetic Product Listing Number, or a name (but not both). 

36.1.6.4 Product reference refers to one listed product or part product either by name or 

by product listing number. 

36.1.6.5 If the facility has no small business designation, then there is an active facility 

registration for this facility with a cosmetic product. 

36.1.6.6 Each listed product is linked from at least one facility. 

36.1.7 Submitter Name and Signature (Legal Authenticator) 

The authorized individual may sign for the responsible organization as follows: 

<document> 

 <author .../> 

 <legalAuthenticator> 

 <noteText>The data and information in this submission have been 

reviewed and, to the best of my knowledge, are certified to be true and 

accurate. I agree to report changes to this information as required under 

section 607 of the Federal Food, Drug, and Cosmetic Act.</noteText> 

 <time value= “”/> 

 <signatureText mediaType=“text/plain”>P. Bauer</signatureText> 

 <assignedEntity> 

 <assignedPerson> 

 <name>Peter Bauer</name> 

 </assignedPerson> 

 <representedOrganization/> 

36.1.7.1 There may be a signature (legalAuthenticator).

36.1.7.2 If present, the signature may contain a signing statement (noteText) exactly as 

above. 
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36.1.7.3 If present, there is one signatureText element. 

36.1.7.4 If present, the signatureText has mediaType “text/plain” and the electronic 

signature in text content.

36.1.7.5 If present, the signature contains one assigned person (the signing person). 

36.1.7.6 If present, assigned person has a name 

36.1.7.7 If present, assigned person has only a name, no other element. 

36.1.7.8 If present, the signature contains an empty representedOrganization element (the 

signer signs for the responsible organization). 

36.1.7.9 There is an time with at least the precision of day in the format YYYYMMDD. 

36.2 Body

36.2.1 Required Sections

Validation Procedures 

36.2.1.1 If the document is a Cosmetic – Abbreviated Renewal (X8888-6), then the 

document body is empty 

36.2.1.2 If the document is a Cosmetic Product Listing (103572-4), Cosmetic – Update

(X8888-5), then there is a document body. 

36.2.1.3 The document body contains one section, the product data element section

36.2.1.4 The section contains the product data elements 

36.2.2 Cosmetic Product 

<section> 

 <subject> 

 <manufacturedProduct> 

 <manufacturedProduct> 

 <code code="53-000000-000001" 

 codeSystem="2.16.840.1.113883.3.9848"/> 

 <name>Juvenia Soft</name> 

 <asSpecializedKind> 

 <generalizedMaterialKind> 

 <code code="01B" codeSystem="2.16.840.1.113883.6.345" 

 displayName="Baby products – Lotions, oils, powders, and creams"/> 

 <ingredient>... 
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The cosmetic listing number is included in any update after it has been assigned 

subsequent to an initial cosmetic product listing submission.

Validation Procedures

36.2.2.1 If a product by the same name has been included in the previous version of the 

cosmetic product listing, then the assigned Cosmetic Product Listing Number is 

included.

36.2.2.2 Code system is 2.16.840.1.113883.3.9848 (Cosmetic Product Listing Number).

36.2.2.3 The Cosmetic Product Listing Number has the format 53-XXXXXX-XXXXXX

where X stands for any digit 0 to 9.

36.2.2.4 The Cosmetic Product Listing Number has previously been assigned by the 

FDA.

36.2.2.5 [RESERVED]

36.2.2.6 The product names in the listing are unique.

36.2.2.7 If the products names in the listing are not unique, then there is also 

distinguishing information for identification purposes.

36.2.2.8 If the product names in the listing are not unique and the distinguishing 

information is confidential, then the distinguishing information is in parenthesis.

36.2.2.9 If the product names in the listing are unique, then there may be also 

distinguishing information for identification purposes.

36.2.2.10 If the product names in the listing are unique and distinguishing information is 

confidential, then the distinguishing information is in parenthesis.

36.2.2.11 There are one or more cosmetic product category codes (asSpecializedKind 

element) with a code (see Section 3.4.3).

36.2.2.12 Name, ingredients (including fragrance, color, and flavor) match the name for 

the cosmetic product, as such name appears on the label previously assigned to 

this listing number and the responsible person’s name included in the previous 

version of this file.

36.2.2.13 Cosmetic product category matches the cosmetic product category previously 

assigned to this listing number.

36.2.2.14 There are one or more ingredients (as per Section 3.4.4)
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36.2.2.15 There may be a web page link as per Section 3.4.6.2

36.2.2.16 There may be a professional use indicator as per Section 3.4.8.

36.2.2.17 There may be a label image as per Section 3.4.9.
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Appendix

List of Tables

Table 1: Marketing Category and Product Type............................................................... 37

Table 2: Equivalence Codes.............................................................................................. 41

Table 3: Miscellaneous Identifier Types........................................................................... 43

Table 4: Characteristic codes and code systems............................................................... 66

Table 5: Conventions for expressing strength .................................................................. 75

Table 6: Characteristic codes and code systems............................................................... 95

Table 7: Document Types for Labeling , Listing, and other Product Submissions........ 105

Table 8: Document Types and Marekting Categories for which even completed product 

listings should have establishments. ............................................................................... 109

Table 9: Cosmetic Facility Registration Document Types............................................. 254

Table 10: Cosmetic Listing Document Types ................................................................ 262