Statement of Identity and
 
Strength  Content and 
Format of Labeling for 
Human Nonprescription 
Drug Products 
Guidance for Industry 
 
 
 
DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) the Office of Nonprescription 
Drugs at 301-796-6848. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2022 
Labeling 
32128059dft.docx 
8/30/2022   
Statement of Identity and 
Strength  Content and 
Format of Labeling for 
Human Nonprescription 
Drug Products 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD  20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2022 
Labeling 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  CONTENT AND FORMAT OF THE STATEMENT OF IDENTITY AND 
STRENGTH ...................................................................................................................... 2 
A.  Content of the Statement of Identity ............................................................................................ 2 
1. Established Name ............................................................................................................................ 3 
2. Pharmacological Category .............................................................................................................. 4 
B.  Strength ........................................................................................................................................... 4 
C.  Formatting and Placement of the Statement of Identity and Strength ..................................... 4 
1. Direct Conjunction of the Proprietary Name and Statement of Identity.......................................... 4 
2. Configuration of the Statement of Identity and Strength ................................................................. 5 
3. Prominence ...................................................................................................................................... 7 
APPENDIX:  CONFIGURATION OF THE STATEMENT OF IDENTITY AND 
STRENGTH .................................................................................................................................. 8 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Statement of Identity and Strength  Content and Format  
2  of Labeling for Human Nonprescription Drug Products 
3  Guidance for Industry1 
4   
5   
6   
7   
8  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
10  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
11  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
12  for this guidance as listed on the title page. 
13   
14   
15   
16   
17  I.  INTRODUCTION 
18   
19  This guidance provides recommendations on the labeling of human nonprescription drug 
20  products for the content and format of the required statement of identity2 and the drug products 
21  strength.3  The recommendations in this guidance are intended to help manufacturers4 ensure 
22  consistent content and format of the statement of identity and strength for all nonprescription 
23  drug products.  
24   
25  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
26  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
27  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
28  the word should in Agency guidances means that something is suggested or recommended, but 
29  not required. 
30   
31   
 
1 This guidance has been prepared by the Office of Nonprescription Drugs in the Center for Drug Evaluation and 
Research at the Food and Drug Administration.  
 
2 See 21 CFR 201.61. 
 
3 For purposes of this guidance, we interpret the term nonprescription drug products to cover over-the-counter 
(OTC) drug products marketed under a new drug application, abbreviated new drug application, or as an OTC 
monograph drug under section 505G of the Federal Food, Drug, and Cosmetic Act.  This guidance does not apply to 
human prescription drugs or biologic products or human nonprescription biological products. 
 
4 Manufacturers, packers, distributors, applicants, relabelers, and sponsors are henceforth referred to as 
manufacturers.   
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
32  II.  BACKGROUND 
33   
34  Labeling for nonprescription drug products is intended to enable consumers to self-select 
35  appropriately and use the nonprescription drug product safely and effectively without the 
36  supervision of a health care practitioner.  Nonprescription drug products must comply with 
37  applicable labeling requirements under 21 CFR part 201, including, but not limited to, the 
38  statement of identity under section 201.61.  The statement of identity is one of the principal 
39  features on nonprescription drug product labeling and consists of the established name for the 
40  nonprescription drug product, if one exists, followed by an accurate statement of the general 
41  pharmacological category(ies) or the principal intended action(s) of the drug product.5  The 
42  labeling of all nonprescription drug products must display the statement of identity on the drug 
43  products principal display panel (PDP).6, 7  Consistent content and format of the statement of 
44  identity and strength8, 9 on the PDP may aid consumers in comparing nonprescription drug 
45  products and assist consumers in appropriate self-selection.    
46   
47   
48  III.  CONTENT AND FORMAT OF THE STATEMENT OF IDENTITY AND 
49  STRENGTH 
50   
51  A.  Content of the Statement of Identity 
52   
53  The statement of identity must consist of the established name for the nonprescription drug 
54  product, if one exists, followed by an accurate statement of the general pharmacological 
55  category(ies) or the principal intended action(s) of the drug product.10  For over-the-counter 
56  (OTC) monograph drug products, if the applicable OTC monograph contains a statement of 
57  identity, the drug product must use the statement of identity in the applicable monograph.11  
58  However, to the extent they are not consistent, FDA does not intend to take action against the 
59  marketing of an OTC monograph drug product that follows the content guidelines for the 
 
5 See 21 CFR 201.61(a) and (b). 
 
6 The term principal display panel (PDP), as it applies to over-the-counter drugs in package form, means the part of 
a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for 
retail sale.  The PDP shall be large enough to accommodate all the mandatory label information required to be 
placed thereon by [21 CFR part 201] with clarity and conspicuousness and without obscuring designs, vignettes, or 
crowding (21 CFR 201.60).   
 
7 See 21 CFR 201.61(a). 
 
8 See the guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize 
Medication Errors (May 2022).  We update guidances periodically.  To make sure you have the most recent version 
of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents. 
 
9 See the guidance for industry Safety Considerations for Product Design to Minimize Medication Errors (April 
2016). 
 
10 See 21 CFR 201.61(b). 
 
11 See section 505G(a) of the Federal Food, Drug, and Cosmetic Act; 21 CFR 330.1(c)(1). 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
60  statement of identity as described in this guidance rather than the applicable OTC drug 
61  monograph, as long as the drug product is marketed in compliance with all other applicable 
62  statutes, regulations, and requirements (including other applicable requirements set forth in a 
63  corresponding OTC drug monograph).  
64   
65  1.  Established Name 
66   
67  The term established name is defined in section 502(e)(3) of the Federal Food, Drug, and 
68  Cosmetic Act (FD&C Act) as an official name designated pursuant to section 508 of the FD&C 
69  Act.  If no such official name has been designated, and the drug or ingredient is an article 
70  recognized in an official compendium (such as the United States Pharmacopeia (USP)), then the 
71  established name is the official title described in such compendium.12  If neither of the two 
72  options above applies, then the established name is the common or usual name of the drug.  FDA 
73  does not routinely designate official names under section 508 of the FD&C Act.13, 14  Therefore, 
74  the established name of a drug product will ordinarily be the USP drug product monograph title 
75  for that drug product.    
76   
77  The USP General Chapter <1121> Nomenclature and USP Nomenclature Guidelines describe 
78  the general format for a drug product monograph title as [DRUG] [ROUTE OF 
79  ADMINISTRATION] [DOSAGE FORM].  For some dosage forms, the route of administration 
80  (ROA) is omitted.15  Consistent with these principles, if there is no USP drug product 
81  monograph for a nonprescription drug product with a single active ingredient, FDA recommends 
82  that the nonprescription drug product use the USP drug substance monograph title [DRUG], 
83  which should be followed by the [ROA] [DOSAGE FORM], as the established name of the 
84  drug product.16   
85   
86  For a nonprescription drug product that consists of a mixture of two or more active ingredients 
87  and that does not have a USP drug product monograph, FDA recommends that the 
 
12 In general, manufacturers of OTC drug products should refer to 21 CFR 299.4(e) on established names for drugs, 
as well as USP General Chapter <1121> Nomenclature available at http://www.usp.org and the USP Nomenclature 
Guidelines available at https://www.usp.org/health-quality-safety/compendial-nomenclature. 
 
13 See 21 CFR 299.4(e); see also the final rule, Designated Names: Revocation of List of Official Names of Drugs, 
published September 25, 1984 (49 FR 37574).   
 
14 The terminology common or usual name of the drug refers to a historical concept that with time has fallen out 
of use.  See the final rule, Designated Names: Revocation of List of Official Names of Drugs, published 
September 25, 1984 (49 FR 37574) (explaining that common or usual name was used to refer to names for drug 
products adopted in USAN (U.S. Adopted Names) and the USP Dictionary of Drug Names).  Therefore, we 
recommend following the more typically used USP drug product monograph compendial name. 
 
15 The ROA is omitted from dosage form titles for which the ROA is understood.  Some examples include oral for 
orally administered capsules, tablets, and lozenges and topical for products such as topically applied creams, 
ointments, and lotions.  See the USP Nomenclature Guidelines for more detailed information on this topic.  
 
16 When the drug substance is a salt, see the guidance for industry Naming of Drug Products Containing Salt Drug 
Substances (Salt guidance) (June 2015).  While the Salt guidance addresses prescription drug products approved 
under the FD&C Act, FDA applies the principles in the Salt guidance for naming nonprescription drug products to 
align with USP General Chapter <1121> and the USP Nomenclature Guidelines.   
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
88  nonprescription drug product use the applicable USP drug substance monograph title17 for each 
89  active ingredient in the drug product, which should be followed by the [ROA] [DOSAGE 
90  FORM], as the established name of the drug product.18  Further, in general, FDA recommends 
91  that each drug substance monograph title for each active ingredient in such a drug product be 
92  listed in alphabetical order.19  
93   
94  2.  Pharmacological Category 
95   
96  The pharmacological category is based on the principal intended action(s) of the nonprescription 
97  drug product.  For OTC monograph drug products, the pharmacological category is specified in 
98  the applicable OTC drug monograph.20   
99   
100  B.  Strength 
101   
102  FDA recommends that the strength of the drug products active ingredient(s)21 immediately 
103  follows the statement of identity on the PDP.   
104   
105  C.  Formatting and Placement of the Statement of Identity and Strength 
106   
107  1.  Direct Conjunction of the Proprietary Name and Statement of Identity 
108   
109  FDA recommends that the statement of identity be placed either directly to the right of or 
110  directly below the most prominent display of the proprietary name in the PDP.  The statement of 
111  identity must be placed in direct conjunction with the most prominent display of the proprietary 
 
17 When the drug substance is a salt, see the Salt guidance.  
 
18 For some dosage forms, the ROA is omitted.  The ROA is omitted from dosage form titles for which the ROA is 
understood.  Some examples include oral for orally administered capsules, tablets, and lozenges and topical for 
products such as topically applied creams, ointments, and lotions.  See the USP Nomenclature Guidelines for more 
detailed information on this topic. 
 
19 There may be cases when FDA has determined or recommended a listing configuration other than alphabetical 
order for active ingredient names in the statement of identity.  A possible example could be that of a prescription to 
OTC switch, where the consumer or health care practitioner may already be familiar with a particular listed order 
based on historical practice, and a change in order might negatively affect how the health care practitioner 
recommends the drug product or how the consumer uses the drug product.  These cases should be further discussed 
with FDA.    
 
20 See 21 CFR 330.1(c)(1); FD&C Act section 505G(a). 
 
21 When the drug substance is a salt, see the Salt guidance. 
 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
112  name,22 if one is present.23, 24  This implies that the proprietary name and the statement of 
113  identity should not be separated by any intervening matter, such as a logo, tagline, descriptor, or 
114  any other graphic, which may detract, obfuscate, or de-emphasize the statement of identity.  FDA 
115  does not consider trademark symbols associated with proprietary names on the PDP (e.g., 
116  registered trademark symbols (), unregistered trademark symbols (TM)) to be intervening 
117  matter.  The statement of identity must be in lines generally parallel to the base on which the 
118  package rests as it is designed to be displayed.25   
119   
120  2.  Configuration of the Statement of Identity and Strength 
121   
122  FDA recommends the following configurations for the statement of identity and strength in 
123  labeling for nonprescription drug products: 
124   
125    Recommendation 1:  for a nonprescription drug product with a single active ingredient, 
126  the statement of identity and strength should be consistent with any of the following 
127  configurations:26   
128   
129  [Established Name] [Pharmacological Category] [Strength] 
130   
131  OR 
132   
133  [Established Name] [Pharmacological Category]  
134  [Strength] 
135   
136  OR 
137   
138  [Established Name]  
139  [Pharmacological Category]   
140  [Strength] 
141   
142    Recommendation 2:  for a nonprescription drug product that consists of a mixture of 
143  active ingredients, the established name should be followed by the pharmacological 
 
22 The proprietary name of a drug product is its brand name (sometimes referred to as the products trade name).   
 
23 See 21 CFR 201.61(b). 
 
24 Drug products marketed without a proprietary name may use the statement of identity and strength as the product 
title of the nonprescription drug product (see the second example in the Appendix).  Alternatively, the established 
name of the drug product may be used as the product title followed by the statement of identity and strength (see the 
last example in the Appendix).    
 
25 See 21 CFR 201.61(c).  
 
26 Consistent with the recommendation in section III.A.1., Established Name, of this guidance, if there is no USP 
drug product monograph for a nonprescription drug product with a single active ingredient, FDA recommends that 
the established name be presented as the USP drug substance monograph title [DRUG], followed by the [ROA] 
[DOSAGE FORM]. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
144  category and the strength of each active ingredient.27  To reduce redundancy and 
145  consumer confusion, the statement of identity should appear vertically aligned in columns 
146  consistent with the following configuration:   
147   
[Drug A]  [Pharmacological Category A]  [Strength A] 
[Drug B]  [Pharmacological Category B]  [Strength B] 
[Drug C]  [Pharmacological Category C]  [Strength C] 
[ROA] [Dosage Form]     
148   
149    Recommendation 3:  in cases in which the ROA is omitted, the statement of identity and 
150  strength should appear consistent with the following configuration: 
151   
[Drug A]  [Pharmacological Category A]  [Strength A] 
[Drug B]  [Pharmacological Category B]  [Strength B] 
[Drug C]  [Pharmacological Category C]  [Strength C] 
[Dosage Form]     
152   
153  Though the configurations in Recommendations 1, 2, and 3 have left-aligned text, in general, text 
154  for the statement of identity and strength can be presented in other alignment types (e.g., center 
155  aligned, right aligned, justified).   
156   
157  An OTC monograph drug product must follow the applicable requirements specified in its OTC 
158  monograph, including requirements for the statement of identity.28  However, to the extent they 
159  are not consistent, FDA does not intend to take action against the marketing of an OTC 
160  monograph drug product that follows the content and formatting guidelines for the statement of 
161  identity and strength as described in this guidance rather than the applicable OTC monograph, as 
162  long as the drug product is marketed in compliance with all other applicable statutes, regulations, 
163  and requirements (including other applicable requirements set forth in a corresponding OTC drug 
164  monograph).   
165   
 
27 Consistent with the recommendation in section III.A.1, Established Name, of this guidance, for a nonprescription 
drug product that consists of a mixture of two or more active ingredients and that does not have a USP drug product 
monograph, FDA recommends that the established name be presented as the applicable USP drug substance 
monograph title for each active ingredient in the drug product (in alphabetical order), followed by the [ROA] 
[DOSAGE FORM]. 
 
28 Section 505G of the FD&C Act. Nonprescription drug products marketed under the OTC drug review  are 
referred to as OTC monograph drugs.  An OTC monograph drug can be marketed without an approved drug 
application described in section 505 of the FD&C Act if it meets the requirements of section 505G of the FD&C Act 
(known as the OTC drug review), as well as other applicable requirements. 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
166  3.  Prominence 
167   
168  The statement of identity must be presented in bold face type.29, 30  FDA recommends the 
169  statement of identity be at least half the size of the most prominent printed matter on the PDP.31, 
170  32  Furthermore, the statement of identity should be prominent on the PDP considering all 
171  pertinent factors, including typography, layout, contrast, and other printing features on the PDP.  
172  FDA recommends that the strength, following the statement of identity on the PDP, also be 
173  presented in bold face type.   
174   
 
29 See 21 CFR 201.61(c). 
 
30 In certain instances, there may be additional formatting requirements for the statement of identity.  For example, 
see 21 CFR 201.326(a)(1)(i).   
 
31 At times, there may be additional size requirements for the statement of identity.  For example, see 21 CFR 
201.326(a)(1)(i)(A) and (B). 
 
32 See 21 CFR 201.15. 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
175  APPENDIX:  
176  CONFIGURATION OF THE STATEMENT OF IDENTITY AND STRENGTH 
177   
178  The following principal display panels are examples of appropriate configuration for the 
179  statement of identity and strength in labeling for a nonprescription drug product with multiple 
180  active ingredients.1 
181   
 
 
Proprietary Name 
 
[Drug A] [Pharmacological Category A] [Strength A]  
[Drug B] [Pharmacological Category B] [Strength B] 
[Drug C] [Pharmacological Category C] [Strength C] 
[ROA] [Dosage Form]    
 
 
 
 
 
 
Net Quantity of Contents  
   
  Drug A, Drug B, and Drug C 
[Drug A] [Pharmacological Category A] [Strength A]  
[Drug B] [Pharmacological Category B] [Strength B]  ROA Dosage Form 
[Drug C] [Pharmacological Category C] [Strength C] 
 
[ROA] [Dosage Form]    
[Drug A] [Pharmacological Category A] [Strength A]  
  [Drug B] [Pharmacological Category B] [Strength B] 
  [Drug C] [Pharmacological Category C] [Strength C] 
  [ROA] [Dosage Form]    
   
   
   
Net Quantity of Contents   
Net Quantity of Contents 
182   
 
1 ROA = route of administration.  The ROA is omitted from dosage form titles for which the ROA is understood.  
Some examples include oral for orally administered capsules, tablets, and lozenges and topical for products such as 
topically applied creams, ointments, and lotions.  See the USP Nomenclature Guidelines for more detailed 
information on this topic. 
  8