Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        FDA Data Standards Advisory Board

Structured Product Labeling Resources

                        
                Business Entity Identifiers
          Business Operation
          Business Operation Qualifier
          Code System Object Identifiers
          Combination Product Types
          Contributing Factor - General
          Document Type including Content of Labeling Type
          Dosage Forms
          Electronic Animal Drug Product Listing Directory
          Equivalence Codes
          Flavor
          Geopolitical Entities, Names, and Codes (GENC)
          Indication Category
          Intent of Use
          Lab Test
          License Disciplinary Action
          Licensed
          Limitation of Use/Issues
          Marketing Category
          Marketing Status
          Medical Condition
          NDC/NHRIC Labeler Codes
          NSDE
          Package Type
          Pharmacokinetic Effect
          Pharmacologic Class
          Positron Emission Tomography (PET) Drug SPL
          Precondition Categories
          Race
          REMS Approval
          REMS Protocol
          REMS Requirements
          REMS Stakeholder
          Resources for SPL Commercial Software and Conversion Vendors and FDA-Regulated Company Self-Generated SPL Software Developers
          Risk Evaluation and Mitigation Strategies (REMS) SPL Resources
          Route of Administration
          Section Headings (LOINC)
          Sex
          SPL Color
          SPL DEA Schedule
          SPL Lot Distribution Data - Distribution Codes
          SPL Shape
          SPL Standard Training
          SPL Xforms
          Time Units
          Type of Consequence
          UNIIs, Preferred Substance Names, and their Identified Synonyms
          Units of Measure
          Units of Presentation Home
          For Industry
          FDA Data Standards Advisory Board
          Structured Product Labeling ResourcesFDA Data Standards Advisory Board Structured Product Labeling Resources
  	
        Share
    Post
    Linkedin

    Email
    PrintThe Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

SPL Guidance Documents

Compounding Animal Drugs from Bulk Drug Substances (draft guidance)
	DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics (draft guidance)
	Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (final guidance)
	Electronic Submission of Lot Distribution Reports (final guidance)
	Format and Content of a REMS Document (draft guidance)
	Indexing Structured Product Labeling (final guidance)
	Providing Regulatory Submissions in Electronic Format - Content of Labeling (final guidance)
	Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling (final guidance)
	Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing (final guidance)
	Public Availability of Labeling Changes in “Changes Being Effected” Supplements (draft guidance)
	Registration and Listing of Cosmetic Product Facilities and Products (draft guidance)
	Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (final guidance)
	Self-Identification of Generic Drug Facilities, Sites, and Organizations (draft guidance)
	SPL Standard for Content of Labeling Technical Questions and Answers (draft guidance)**SPL Implementation Guide and Validation Procedures**

SPL Implementation Guide with Validation Procedures v1.0
	Step-by-Step Instructions for Creating SPL Files for Drug Establishment Registration and Drug Listing v2.0GDUFA SPL Step-by-Step Instructions & Technical Specifications

GDUFA Self ID SPL Industry Technical Specification Information (PDF)
	GDUFA SPL Step-by-Step Instructions for Self-Identification of Facilities, Sites, and Organizations(PDF)SPL Dockets

SPL Docket 92S-0251 - Drug Establishment Registration and Drug Listing (PDF)
	SPL Docket 92S-0251 - Content of Labeling-CDER (PDF))
	SPL Docket 92S-0251 - Content of Labeling - CBER (PDF)
	SPL Docket 92S-0251 - Blood and Tissue Establishment Registration and Product Listing (PDFSPL Schema and Stylesheet

FDA SPL Schema for Implementation (zip file last updated April 25, 2016)
	FDA SPL stylesheet (zip file last updated October 24, 2016) - send comments to spl@fda.hhs.govDownload Labeling

FDALabel: FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results.
	FDA Online Label RepositoryResources

Comprehensive NDC SPL Data Elements File (NSDE)
	Indexing SPL Fact Sheet
	SPL Standard Training
	SPL Xforms
	SPL Training Material
	FDA Electronic Secure Gateway
	SPL Software and Conversion Vendors
	CDER Direct
	CVM SPL Xforms
	REMS SPL ResourcesSPL Terminology

Business Entity Identifiers
	Business Operation
	Business Operation Qualifier
	Code system object identifiers (OIDs)
	Color
	Combination Product Types
	Cosmetic Product Categories and Codes
	Document Type including Content of Labeling Type
	Dosage form
	Equivalence Codes
	Flavor
	Geopolitical Entities, Names, and Codes (GENC)
	Lot Distribution Data - Distribution Codes
	Marketing Category
	Marketing Status
	Package type
	Route of administration
	Section headings
	Shape
	SPL DEA Schedule
	Time Units: Unified Code for Units of Measure (UCUM)
	UNIIs, Preferred Substance Names, and their Identified Synonyms
	Units of measure
	Units of presentationSPL Terminology Files for Validation

Action (XML)
	Active Ingredient-Active Moiety Relationship/Basis of Strength (Excel & XML)**(Not applicable for SPL files w/bulk ingredient marketing category.)**
	Additional Validation Files (XML)
	Blood Donor Type (Excel and XML)
	Blood Product Type (Excel and XML)
	Business Operation Qualifiers (XML)
	Combination Product Category Types (XML and Excel)
	Cosmetic Product Categories and Codes (XML and Excel)
	DEA Schedule
	Device Product Classification disclaimer icon
	Designated Medical Gas
	Dosage Form (XML)
	Lot Distribution Data - Distribution Codes
	Marketing Categories (XML)
	Medication Guides (Excel and XML)
	Physician Labeling Rule Content of Labeling & Application Number Validation (Excel and XML)
	Product Concept Validation (CSV)
	REMS Approval (XML)
	REMS Protocol (XML)
	REMS Requirements (XML)
	REMS Stakeholder (XML)
	SPL Terminology Validation Files (XML)
	Tissue Donor Type (Excel and XML)
	Tissue Establishment Function Type (Excel and XML)
	Tissue Establishment Type (Excel and XML)
	Tissue Product Group (Excel and XML)
	Tissue Product Type (Excel and XML)
	Unique Ingredient Identifiers (UNII) (XML)
	Vaccine Substances Validation File (XML)Terminology for Indexing SPL

Contributing Factor - General
	Indication Category
	Intent of Use
	Lab Test
	Limitation of Use/Issues
	Medical Condition
	Pharmacokinetic Effect
	Pharmacologic Class
	Precondition Categories
	Race
	Sex
	Type of ConsequenceContact Information

Questions regarding SPL submissions should be directed to: spl@fda.hhs.gov.

Resources For You

NCPDP WG2 SPL Activities Task Group

                                                                                  Content current as of:
      11/30/2023Structured Product Labeling Resources                
                          

                        Business Entity Identifiers
          Business Operation
          Business Operation Qualifier
          Code System Object Identifiers
          Combination Product Types
          Contributing Factor - General
          Document Type including Content of Labeling Type
          Dosage Forms
          Electronic Animal Drug Product Listing Directory
          Equivalence Codes
          Flavor
          Geopolitical Entities, Names, and Codes (GENC)
          Indication Category
          Intent of Use
          Lab Test
          License Disciplinary Action
          Licensed
          Limitation of Use/Issues
          Marketing Category
          Marketing Status
          Medical Condition
          NDC/NHRIC Labeler Codes
          NSDE
          Package Type
          Pharmacokinetic Effect
          Pharmacologic Class
          Positron Emission Tomography (PET) Drug SPL
          Precondition Categories
          Race
          REMS Approval
          REMS Protocol
          REMS Requirements
          REMS Stakeholder
          Resources for SPL Commercial Software and Conversion Vendors and FDA-Regulated Company Self-Generated SPL Software Developers
          REMS SPL Resources
          Route of Administration
          Section Headings (LOINC)
          Sex
          SPL Color
          SPL DEA Schedule
          SPL Lot Distribution Data - Distribution Codes
          SPL Shape
          SPL Standard Training
          SPL Xforms
          Time Units
          Type of Consequence
          UNIIs, Preferred Substance Names, and their Identified Synonyms
          Units of Measure
          Units of Presentation
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop