Best Practices in Developing 
Proprietary Names 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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 http://www.regulations.gov.  Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Room 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) Office of Surveillance and 
Epidemiology, Division of Medication Error Prevention and Analysis, Danielle Harris at 301-
796-4590, or (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 
240-402-8010.  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 
December 2020 
Drug Safety 
 
12/07/20   
Best Practices in Developing 
Proprietary Names 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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
and/or  
Office of Communication, Outreach and Development, HFM-40 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
 Silver Spring, MD 20993  
Phone: 800-835-4709 or 240-402-7800 
ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
December 2020 
Drug Safety 
Draft Guidance Temp 
12/07/20  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  RECOMMENDATIONS FOR DEVELOPING AND EVALUATING NOVEL 
NONPRESCRIPTION DRUG PRODUCT PROPRIETARY NAMES .................................. 5 
A.  Additional Best Practices for Evaluation of Proposed Names ................................................... 5 
1. Names That Include Reference to Product-Specific Attributes ........................................................ 6 
2. Medical Abbreviations ..................................................................................................................... 6 
3. Proprietary Names of Drug Products Marketed Outside of the United States ................................ 7 
4. Incorporation of the Sponsors Name .............................................................................................. 7 
5. Modifiers as Components of a Nonprescription Proprietary Name ................................................ 7 
B.  Recommended Methods for Evaluating Risks for Medication Error Posed by Similarity of a 
Proposed Proprietary Name to Other Names ...................................................................................... 8 
1. Name Simulation Studies ................................................................................................................. 8 
2. Computational Method To Identify Names With Potential Orthographic, Spelling, and Phonetic 
Similarities ........................................................................................................................................... 9 
C.  Further Best Practices for Review, Including for Misbranding and Other Legal Concerns .. 9 
IV.  RECOMMENDATIONS PERTAINING TO THE USE OF A PROPRIETARY 
NAME ALREADY ASSOCIATED WITH MARKETED PRODUCT(S) ............................ 10 
A.  Brand Name Extension ................................................................................................................ 10 
B.  Family Branding (Family Trade Names) ................................................................................... 11 
C.  Obtaining Medication Error Data for Names That Are Already Associated With Marketed 
Products ................................................................................................................................................. 12 
V.  RECOMMENDATIONS FOR DRUG PRODUCTS SWITCHING FROM 
PRESCRIPTION TO NONPRESCRIPTION USE ................................................................. 12 
A.  Full Prescription-to-Nonprescription Switch ............................................................................ 13 
B.  Partial Prescription-to-Nonprescription Switch ....................................................................... 13 
VI.  CONCLUSION ............................................................................................................... 13 
GLOSSARY................................................................................................................................. 14 
Appendix A:  Examples of Previously Used Nonprescription Drug Modifiers and Their 
Commonly Understood Meanings ............................................................................................. 17 
Draft Guidance Temp 
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Guidance for Industry1
1   
2   
Best Practices in Developing Proprietary Names for Human 
3 
Nonprescription Drug Products  
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  I.  INTRODUCTION  
15  FDA is issuing this guidance to help sponsors of human nonprescription drug products develop 
16  proprietary names2 for those products. This guidance describes best practices to help minimize 
  
17  proprietary name-related medication errors and otherwise avoid adoption of proprietary names 
18  that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its 
19  implementing regulations.  It also describes the framework FDA uses in evaluating proposed 
20  proprietary names that is available to sponsors to use for nonprescription drug products before a 
21  product bearing that proprietary name is marketed.  This guidance does not address the 
22  designation of established names or proper names. 
23   
24  This guidance applies to all human nonprescription drug products, including those approved 
25  under a new drug application (NDA), abbreviated new drug application (ANDA)3, or biologics 
26  license application (BLA)4, and those that can be  marketed without approved applications in 
27  accordance with requirements for nonprescription drugs under section 505G of the FD&C Act 
28  (21 U.S.C. 355h) ( often referred to as over-the-counter (OTC) monograph drugs).5  In this 
                                                 
1  This guidance was prepared by the Office of Surveillance and Epidemiology, Division of Medication Error 
Prevention and Analysis in the Center for Drug Evaluation and Research (CDER), and the Advertising and 
Promotional Labeling Branch in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug 
Administration. 
2 Terms that appear in bold type upon first use are described in the Glossary, as they are used in this guidance. 
3 With regard to NDAs and ANDAs, see section 505(b) and (j) of the FD&C Act (21 U.S.C. 355(b) and (j)). 
4 See section 351 of the Public Health Service Act (42 U.S.C. 262). 
5 Under section 505G, to be legally marketed without a new drug application approved under section 505, a 
nonprescription drug product must meet requirements that include conformity with applicable conditions for 
nonprescription use for the drug or class of drugs (such as those described in section 505G(a)(1)-(3) or established 
by order under section 505G(b)), as well as conformity with the general requirements for nonprescription drugs, 
which include labeling requirements under the Act and regulations.  
 
 
 
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29  guidance, all such products are jointly referred to as products, and persons responsible for 
30  developing the products are referred to as sponsors. 
31  A separate guidance is available describing best practices in developing proprietary names for 
32  human prescription drug products.6 
33  This guidance recommends best practices for sponsors considering proprietary names for 
34  nonprescription drugs and is intended to provide sponsors clarity and transparency with respect 
35  to the factors and framework FDA uses to evaluate proposed proprietary names for 
36  nonprescription drugs that are subject to premarket review.  Use of the best practice 
37  recommendations and other assessment tools addressed in this guidance is not mandatory, and 
38  their application does not dictate specific outcomes.  Assessments of a proprietary name are 
39  necessarily fact-specific and thus, where FDA makes a determination about the acceptance of a 
40  proprietary name for a nonprescription drug as part of the new drug approval process, it does so 
41  on a case-by-case basis, considering the totality of the information. 
42  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
43  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
44  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
45  the word should in Agency guidances means that something is suggested or recommended, but 
46  not required. 
47  II.  BACKGROUND 
48  Selecting a proprietary name is a critical element in drug product design and development 
49  because end users may rely, in part or in whole, on the proprietary name to identify which 
50  product, among thousands of available products, is intended for or used by a particular person.  
51  Nonprescription drug product proprietary names are used by consumers, patients, caregivers, 
52  physicians and other health care professionals as primary product identifiers.  Having a 
53  proprietary name that facilitates accurate identification of a nonprescription drug product by 
54  these end users is critical for its safe and effective use.  For example, if end users cannot easily 
55  identify a nonprescription product or distinguish a proprietary name from other drug names that 
56  are similar phonetically (sound-alike names) or in their spelling or orthographic appearance 
57  (look-alike names), or if the drug name is otherwise confusing or misleading, the end user might 
58  select or receive the wrong product or it might not be possible to correctly identify the product 
59  used.  Using best practices for selecting a proprietary name for a nonprescription drug helps 
60  minimize these hazards, which in turn both promotes public health and helps to ensure that the 
61  product conforms to legal requirements under the FD&C Act. 
62  To inform their risk assessment of a proposed nonprescription product proprietary name, 
63  sponsors should consider how their nonprescription product will be used by consumers, patients, 
64  caregivers, physicians and other health care professionals. 
                                                 
6 See the FDA guidance for industry Best Practices in Developing Proprietary Names for Human Prescription 
Drug Products for design practices to help minimize errors with prescription proprietary names. We update 
guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs 
guidance web page, available at: 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
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65  Commonly, nonprescription products are selected, purchased, and used by consumers without 
66  the involvement of a health care professional.  In cases where nonprescription products are 
67  recommended or prescribed by health care professionals, this is commonly done using the 
68  proprietary name.7,8  Nonprescription products are also used in a variety of health care settings, 
69  including hospitals, emergency departments, and long term-care facilities, and their proprietary 
70  names are used during prescribing, ordering, transcribing, dispensing, administration, or 
71  medication reconciliation processes.  Some nonprescription medication-use processes, for 
72  example, transcribing and medication reconciliation, involve the use of a nonprescription product 
73  proprietary name without referring to the principal display panel (PDP) or drug facts labeling 
74  (DFL).  Our post-marketing surveillance of medication error reports has found that 
75  nonprescription product proprietary names have been confused with prescription product 
76  proprietary names at various points within the medication-use process.9,10,11,12,13,14 
77  Because proprietary names for nonprescription products are used by health care professionals 
78  throughout the medication-use process in a variety of health care settings, we recommend that 
79  proposed proprietary names for nonprescription products be developed and evaluated using 
80  principles that are like those used for prescription product proprietary names to help ensure that 
81  the proposed proprietary name is not subject to confusion by health care professionals.  
82  Furthermore, because proprietary names for nonprescription products are also used by consumers 
83  without the involvement of a health care professional, FDA recommends additional best 
84  practices (described in more detail below) for the development and evaluation of proposed 
85  nonprescription product proprietary names to help ensure that nonprescription product 
86  proprietary names are also not subject to confusion by consumers, and do not otherwise 
87  contribute to violations of applicable legal requirements. 
88  Proprietary names are used in a products label and labeling, including promotional labeling.  A 
89  drugs labeling, in turn, is often a key element in FDA oversight.  For example, under section 
90  502(a) of the FD&C Act (21 U.S.C. 352(a)), a drug is misbranded if its labeling is false or 
91  misleading in any particular.15  Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) sets forth 
                                                 
7 Tu, CM. Use of Proprietary Names by Prescribers when Prescribing Over-the-Counter (OTC) Drug Products. 
Therapeutic Innovation & Regulatory Science, published online April 22, 2018, available at 
http://journals.sagepub.com/doi/pdf/10.1177/2168479018762376   
8 Some consumers seek a prescription for their nonprescription product to qualify the purchase for reimbursement as 
a medical expense under flexible spending arrangements, health reimbursement arrangements, or health savings 
accounts. 
9 Institute for Safe Medication Practices, 2013, Safety briefs: ZERIT (stavudine)  ZYRTEC (cetirizine) mix-up, 
ISMP Med Saf Alert Community/Ambulatory Care, 12(9):2. 
10 Institute for Safe Medication Practices, 2005, Safety briefs: Mucinex-Mucomyst: Too close for comfort, ISMP 
Med Saf Alert Community/Ambulatory Care,.4(1):1-2. 
11 Institute for Safe Medication Practices, 2002, Safety briefs: Mirapex and Miralax confusion, ISMP Med Saf Alert 
Acute Care, 7(20):1. 
12 Institute for Safe Medication Practices, 1996, Safety briefs: More on confirmation bias. ISMP Med Saf Alert 
Acute Care, 1(23):1-2. 
13 Institute for Safe Medication Practices, 2014, Safety briefs: Florinef vs. Floranex, ISMP Med Saf Alert Acute 
Care, 19(2):2-3. 
14 Institute for Safe Medication Practices, 2008, Safety briefs: Benazepril confused with Benadryl, ISMP Med Saf 
Alert Community/Ambulatory Care, 7(12):2. 
15 See also 42 U.S.C. 262(j) with respect to a biological product subject to regulation under section 351 of the Public 
Health Service Act. 
 
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92  certain considerations that shall be considered when determining whether labeling is misleading.  
93  FDA regulations also address some of the ways in which the name of a drug may render its 
94  labeling misleading.16  In addition, labeling is relevant to determining whether a drug is a new 
95  drug under section 201(p) of the FD&C Act that requires premarket approval (see sections 
96  505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). 
97  For nonprescription products that will be marketed under an NDA, ANDA, or BLA, FDA 
98  reviews proposed labeling, including any proposed proprietary name included in that labeling, on 
99  a case-by-case basis as part of the application review process.  Although the Prescription Drug 
100  User Fee Act (PDUFA) and Biosimilar User Fee Act (BsUFA) performance goals provide for 
101  FDA to make a tentative determination of acceptance/non-acceptance of a proposed proprietary 
102  name early in the review process (in instances where the proprietary name review request is 
103  submitted as a complete submission), final acceptance of a proposed proprietary name occurs as 
104  part of the approval of the drug product.17  To reach that conclusion, in addition to considering 
105  the safety and effectiveness data submitted to support approval, FDA considers the information 
106  and analyses about the proposed proprietary name described in this guidance, along with any 
107  additional proprietary name-related information submitted by the sponsor.  In these cases, FDAs 
108  evaluation process is very similar to that which it uses to review proposed proprietary names for 
109  prescription drug products. 
110  However, many nonprescription products and their product-specific labeling, including any 
111  proprietary name, are not reviewed and approved by FDA through product-specific applications 
112  before marketing, but instead can be legally marketed without approved applications if they 
113  conform to applicable requirements under section 505G of the FD&C Act (21 U.S.C. 355h)..  
114  Regardless of which regulatory framework governs market entry of a particular nonprescription 
115  product, we recommend that sponsors follow the best practices described in this guidance.  To 
116  protect the public health, FDA supports proactive efforts to identify and avoid potential problems 
117  before the product is marketed.  Also, sponsors may choose to seek FDAs views on a proposed 
118  proprietary name for an individual nonprescription drug product that they propose to  market 
119  under FD&C Act section 505G, particularly where they have uncertainty about the risks 
120  presented by a proposed name. 
121  Ultimately, regardless of whether a proprietary name has been evaluated by FDA before its use 
122  in marketing the drug product, sponsors have an ongoing obligation to ensure that each marketed 
123  product satisfies applicable requirements, such as ensuring that its labeling is not false or 
124  misleading in any particular.  (See section 502(a) of the FD& C Act).  If a marketed products 
                                                 
16 See, e.g., (21 CFR 201.6(b)) (labeling for a drug containing two or more ingredients may be misleading if the 
name of the drug designated in that labeling includes or suggests the name of one or more but not all of the 
ingredients); (21 CFR 201.10(c)(3)) (labeling of a drug may be misleading if it employs a fanciful proprietary name 
for a drug or ingredient that implies some unique effectiveness or composition when the drug or ingredients is in fact 
a common substance, the limitations of which are readily recognized when it is listed by its established name); (21 
CFR 201.10(c)(5)) (labeling of drug may be misleading if the proprietary name may be confused with the 
proprietary name or established name of a different drug or ingredient because of similarity in spelling or 
pronunciation). 
17 See, e.g., PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022, Items 
I.D.1.d and I.D.2.e. and BsUFA performance goals, see FDAs website at https://www.fda.gov/industry/fda-user-
fee-programs/biosimilar-user-fee-amendments . 
See also the FDA guidance for industry Contents of a Complete Submission for the Evaluation of Proprietary Names 
(April 2016). https://www.fda.gov/media/72144/download 
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125  proprietary name causes or contributes to medication errors, the sponsor of that product should 
126  work expeditiously with FDA to resolve the situation.  If the product does not comply with 
127  applicable requirements, and the sponsor is unwilling to address or resolve an issue voluntarily, 
128  the sponsor and/or the product may be subject to enforcement or regulatory actions. 
129  This guidance is organized as follows: 
130    Section III provides recommendations for developing and evaluating novel proprietary 
131  names for nonprescription drug products. 
132    Section IV describes FDAs current thinking on the use of a proprietary name that is 
133  already associated with a marketed product(s) to introduce a new product. 
134    Section V provides recommendations for proprietary names for products that change 
135  from prescription to nonprescription drug status. 
136  For each category, we believe that no single test or standard is adequate to determine whether a 
137  proposed proprietary name may contribute to errors or otherwise contribute to any violation of 
138  the FD&C Act.  Rather, the current approach to proposed proprietary name evaluation uses a 
139  combination of different and complementary tests. 
140  III.  RECOMMENDATIONS FOR DEVELOPING AND EVALUATING NOVEL 
141  NONPRESCRIPTION DRUG PRODUCT PROPRIETARY NAMES 
142  Sometimes, a sponsor proposes a novel proprietary name for its nonprescription product, for 
143  example, to introduce a new active ingredient or active moiety, a new formulation, a new 
144  indication, or for the purposes of re-branding a product undergoing a prescription-to-
145  nonprescription switch (see section V). 
146  We recommend that sponsors screen novel nonprescription proposed proprietary name 
147  candidates for the attributes described in section III of the guidance for industry Best Practices in 
148  Developing Proprietary Names for Human Prescription Drug Products [December 2020], which 
149  identifies attributes of proposed proprietary names that FDA typically finds concerning.  We 
150  recommend that sponsors screen proposed proprietary name candidates for these attributes as a 
151  first step before proceeding with a full assessment of whether a name is likely to contribute to 
152  medication errors or otherwise contribute to violations of the FD&C Act.  We recommend that 
153  sponsors avoid proposed nonprescription drug product proprietary names that raise concern 
154  during preliminary screening. 
155  In addition to the recommendations for preliminary screening, FDA also recommends that 
156  sponsors consider other important attributes described below during development of a proposed 
157  proprietary name. 
158  A.  Additional Best Practices for Evaluation of Proposed Names 
159  The following best practices are recommended to reduce the likelihood of selecting a 
160  nonprescription drug product proprietary name that contributes to medication errors or other 
161  violations of FDA-administered legal requirements, either at the time of initial product launch or 
162  in the event of future product range expansions. 
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163  1.  Names That Include Reference to Product-Specific Attributes 
164  For flexibility in future product development and naming, FDA recommends that sponsors avoid 
165  incorporating product-specific attributes, such as dosage form (e.g. Nametabs) or route of 
166  administration (e.g. Nameoral), as part of the proposed root proprietary name. It is not 
167  uncommon for product-specific attributes to change during a drugs life cycle with subsequent 
168  introductions of new dosing intervals, formulations, dosage forms, indications, and patient 
169  populations.  If considering a proprietary name that includes or refers to product-specific 
170  attributes, sponsors should be mindful that future changes, such as changes in dosage form or 
171  route of administration, could render the root proprietary name inaccurate and thus unusable for 
172  future formulations.   
173  If references to product-specific attributes are included in the root proprietary name, FDA 
174  recommends that the name be evaluated to ensure that the product-specific attribute is consistent 
175  with the terminology used in the products labeling and does not pose risks for medication error. 
176  2.  Medical Abbreviations 
177  Sponsors are generally discouraged from incorporating symbols, dose designations, and medical 
178  abbreviations commonly used for prescription communication in their proposed proprietary 
179  name because their inclusion could inadvertently introduce a source of error.  Although we 
180  acknowledge that consumers may not be familiar with these elements, health care providers 
181  interact with nonprescription drug product proprietary names in a variety of health care settings 
182  (see section II) and thus, inclusion of these elements in a nonprescription proprietary name can 
183  contribute to confusion among these end users. 
184  We recommend consulting The Joint Commissions Do Not Use list or the Institute for Safe 
185  Medication Practices (ISMP) List of Error-Prone Abbreviations, Symbols, and Dose 
186  Designations when considering the risk that a proposed proprietary name incorporating an 
187  abbreviation, symbol, or dose designation will be subject to misinterpretation.18,19 
188  When evaluating a proposed proprietary name that contains an element that is also an 
189  abbreviation, symbol, or dose designation, FDA recommends considering other factors such as 
190  placement and presentation that may influence interpretation of the element to make sure the way 
191  it is presented in the name is not error-prone.  As an example, po has been used historically as 
192  an abbreviation for oral route of administration in a medication order, typically appearing after 
193  the drug name.  Therefore, while the inclusion of  letters po in the beginning or within the root 
194  proprietary name (e.g., Poname or Napome) is unlikely to be misconstrued as a medical 
195  abbreviation, and thus would not be expected to pose a risk for medication errors, if po is used 
196  in the ending of the root proprietary name or as a modifier (e.g., Namepo or Name PO), this 
197  would increase the likelihood of po being misconstrued as an abbreviation for the oral route of 
198  administration and thus create confusion if this is not the intended meaning. 
                                                 
18 The Joint Commissions Official Do Not Use List of Abbreviations, 2004, available at: 
http://www.jointcommission.org/assets/1/18/Official_Do_Not_Use_List_6_111.PDF.   
19 Institute for Safe Medication Practices, 2010, List of Error-Prone Abbreviations, Symbols, and Dose 
Designations, Horsham (PA), available at: http://www.ismp.org/tools/errorproneabbreviations.pdf. 
 
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199  3.  Proprietary Names of Drug Products Marketed Outside of the United States 
200  Medication errors resulting in dispensing and administering the wrong drug can occur when a 
201  proprietary name for a product marketed in the United States is identical, or nearly identical in 
202  spelling and pronunciation, to the proprietary name of a foreign product containing an entirely 
203  different active ingredient marketed only in a foreign country.20  For this reason, as a best 
204  practice, FDA recommends against proposing a proprietary name for a nonprescription product 
205  that is identical or nearly identical to the proprietary name of a marketed foreign product that 
206  contains an entirely different active ingredient, even if the proposed nonprescription product will 
207  be marketed only in the United States (and the foreign product is not marketed in the United 
208  States). 
209  4.  Incorporation of the Sponsors Name 
210  FDA recommends that sponsors avoid proposed proprietary names that incorporate the sponsors 
211  name, or some part of the sponsors name, across multiple products (e.g., ABCName1, 
212  ABCName2, ABCName3).  This practice results in creating multiple similar proprietary 
213  names, increasing the risk of confusion among the products. 
214  5.  Modifiers as Components of a Nonprescription Proprietary Name 
215  Some proprietary names are constructed of a root proprietary name modified by added words or 
216  components, which are referred to as modifiers.  The modifier portion of a proprietary name 
217  generally consists of one or more letters, symbols, numbers, and/or words, and appears at the 
218  beginning or end of the root proprietary name, typically set off by a space or hyphen.  Sponsors 
219  frequently propose a shared root proprietary name with various modifiers to distinguish among 
220  multiple products that contain at least one shared active ingredient or active moiety (see section 
221  IV). 
222  Modifiers are sometimes used to convey distinguishing characteristics of the proposed 
223  nonprescription product: e.g., the symptom(s) it is intended to treat (Name Allergy), or the 
224  intended population (Childrens Drugname), or frequency of administration (Drugname 
225  12Hour), or formulation (Extra Strength Drugname).  FDA recommends that the proposed 
226  modifier be evaluated to ensure that it is consistent with the characteristics of the proposed 
227  product and that it is not otherwise prone to medication error.  FDA also recommends applying 
228  considerations discussed in section IV.C of guidance for industry Best Practices in Developing 
229  Proprietary Names for Human Prescription Drug Products. 
230  To reduce the risk of medication errors associated with the use of modifiers in proprietary names, 
231  FDA encourages sponsors who choose to use modifiers to select, whenever possible, an existing 
232  modifier with an established meaning that has not been a source of confusion.  See Appendix A 
233  for examples of modifiers which, when intended to express the accompanying meaning, have not 
234  been a source of confusion.  When novel modifiers are used, sponsors are encouraged to test 
235  consumer and health care professional comprehension of the modifier to determine if the 
236  modifier is prone to misinterpretation by the end users.  Such testing could include name 
237  simulation studies or other means. 
                                                 
20 Institute for Safe Medication Practices, 2005, Safety briefs: Same name, different drug, ISMP Med Saf Alert 
Acute Care, 10(1):2. 
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238  B.  Recommended Methods for Evaluating Risks for Medication Error Posed by 
239  Similarity of a Proposed Proprietary Name to Other Names 
240  Where FDA has the opportunity to review a nonprescription products proposed proprietary 
241  name as part of a marketing application, a primary focus of FDAs review of the proposed 
242  proprietary name is avoiding end user error.  When evaluating a proposed proprietary name, 
243  FDA considers many potential sources of error, including phonetic, spelling, and orthographic 
244  similarities, as well as other sources of error identified elsewhere in this guidance. 
245  Specific methods that FDA uses to evaluate proposed proprietary names, as well as methods that 
246  FDA recommends sponsors use for evaluation of proposed proprietary names, are described 
247  below.  The descriptions include methods for identifying existing proprietary names or 
248  established names that could be confused with the sponsors proposed name, as well as methods 
249  for assessing the likelihood and potential effects of name-related medication errors.  When a 
250  proprietary name is submitted as part of an application, if a sponsor includes detailed study 
251  report(s) providing data from its own safety assessment(s) and shows that these data were 
252  generated using a methodology that is generally consistent with that described in this guidance, 
253  FDA intends to use these data to help evaluate the risk that the proposed proprietary name would 
254  contribute to medication errors.  Sponsors are encouraged to conduct each of the types of 
255  assessments described below, but FDA considers what is submitted on its individual merits, 
256  regardless of whether it includes every type of testing described below.21 
257  Furthermore, because nonprescription drug products are often marketed alongside cosmetics and 
258  other self-care products, we recommend that sponsors that conduct such assessments also 
259  consider the risk that the proposed nonprescription product proprietary name will be confused 
260  with marketed cosmetics or other self-care products. 
261  1.  Name Simulation Studies 
262  Name simulation studies conducted by FDA test how health care professionals employed by 
263  FDA respond to the proposed names.22  The studies we carry out are limited in scope because 
264  they involve only FDA staff. Although the sample size in FDAs simulation studies is small, 
265  these studies can provide important qualitative data that can be used to identify the potential 
266  vulnerability of a proposed name to be misinterpreted. The likelihood of observing an error in a 
267  small study is low, so that when an error is observed in a small study, this suggests that there will 
268  be errors in actual use. However, small studies may not be sufficiently sensitive to reliably 
269  identify all risks associated with a proposed proprietary name; the absence of observed errors in 
270  small studies is not conclusive evidence that a proposed name will not be confused with another 
                                                 
21 Because sponsors do not have access to non-public information on pending proposed proprietary drug names, 
when considering a proprietary name in the context of a premarket application for a new drug, FDA generally 
intends to use the methods described in this guidance to generate data to supplement any safety assessments 
provided by sponsors and evaluate the proposed proprietary name for its potential to be confused with non-public 
pending proposed proprietary names that have been submitted to FDA. 
22 See the FDA guidance for industry Best Practices in Developing Proprietary Names for Human Prescription 
Drug Products for design practices to help minimize errors with prescription proprietary names. We update 
guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs 
guidance web page, available at: 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
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271  drug products proprietary name.  For these reasons, FDA believes it would be useful for 
272  sponsors to conduct more comprehensive simulation studies. 
273  Generally, name simulation studies test how subjects respond to a proposed proprietary name by 
274  asking subjects to use the name in conditions that simulate the real world.  The more closely and 
275  fully the simulation approximates real-world use conditions, the more generalizable the results of 
276  the simulation testing.  Name simulation tasks should reflect the full range and variety of tasks 
277  involved in the use of nonprescription drug products.  Nonprescription products are often 
278  selected, purchased, and used by consumers without the oversight of a health care professional.  
279  Additionally, as noted in section II above, nonprescription products may be prescribed, ordered, 
280  transcribed, dispensed, or administered by health care professionals using a proprietary name in a 
281  variety of health care settings.23  Therefore, it is important to evaluate whether all end users, 
282  including consumers and health care professionals, can interpret both written and oral 
283  communications of the proposed proprietary name.  Thus, sponsors should design name 
284  simulation studies for nonprescription product proprietary names to test how consumers and 
285  health care professionals respond to the proposed name.  FDA recommends that sponsors that 
286  conduct such simulation studies consider the study design principles provided in Appendix C of 
287  guidance for industry Best Practices in Developing Proprietary Names for Human Prescription 
288  Drug Products. 
289  2.  Computational Method To Identify Names With Potential Orthographic, Spelling, and 
290  Phonetic Similarities 
291  FDA evaluates the orthographic and phonetic similarity of a proposed proprietary name to other 
292  names by using the Phonetic Orthographic Computer Analysis (POCA)24 software.  See section 
293  VI.C and VI.D of guidance for industry: Best Practices in Developing Proprietary Names for 
294  Human Prescription Drug Products for a description of the methods FDA uses, and recommends 
295  sponsors to use, to evaluate proposed names using the POCA software.   If a sponsor includes 
296  data from its own POCA evaluation as part of a proposed proprietary name submission, FDA 
297  will use it to help evaluate the proposed proprietary name, provided that the methodology 
298  employed to generate the data is generally consistent with the factors outlined in the 
299  aforementioned Guidance. 
300  C.  Further Best Practices for Review, Including for Misbranding and Other Legal 
301  Concerns 
302  Although this guidance focuses primarily on aspects of proprietary names that can contribute to 
303  medication error, it is a best practice to avoid using a proprietary name that could contribute to any 
304  violation of the FD&C Act. 
305  For example, among other things, the FD&C Act provides that a drug is misbranded if its 
306  labeling is false or misleading in any particular (21 U.S.C. 352(a)).  A proprietary name, which 
307  appears in labeling, could result in such misbranding if it is false or misleading, such as by 
308  making misrepresentations with respect to safety or efficacy.  For instance, a fanciful proprietary 
309  name may misbrand a product by suggesting that it has some unique effectiveness or 
                                                 
23 Tu, CM, Use of Proprietary Names by Prescribers When Prescribing Over-the-Counter (OTC) Drug Products, 
Therapeutic Innovation & Regulatory Science, published online April 22, 2018, Available at: 
http://journals.sagepub.com/doi/pdf/10.1177/2168479018762376) 
24 On February 17, 2009 (74 FR 7450), FDA announced the availability of the source code and supporting technical 
documentation for POCA software program royalty-free to the public. 
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310  composition when it is actually a common substance, the limitations of which are readily 
311  recognized when the product is listed by its established name (see 21 CFR 201.10(c)(3)).  As 
312  another example, a drug is a new drug if it is not generally recognized as safe and effective 
313  (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling (21 
314  U.S.C. 321(p)), and it is prohibited to introduce a new drug into interstate commerce without an 
315  approved application (21 U.S.C. 331(d) and 355(a)).  If the proprietary name of a drug suggests 
316  that it be used under conditions for which it is not GRASE and for which it does not have an 
317  approved new drug application, distributing that drug with labeling bearing that proprietary name 
318  would violate the FD&C Act. 
319  IV.  RECOMMENDATIONS PERTAINING TO THE USE OF A PROPRIETARY 
320  NAME ALREADY ASSOCIATED WITH MARKETED PRODUCT(S) 
321  A.  Brand Name Extension 
322  In this guidance, FDA uses the term brand name extension to refer to a naming strategy that 
323  uses a proprietary name that is already associated with one or more marketed drug products, with 
324  or without a modifier, for a product that does not share any active ingredient(s) or active 
325  moiety(ies) with the marketed product(s).  Two examples of what FDA considers as brand name 
326  extension are: 
327  1.  The proprietary name, Drugname, is already associated with a marketed product 
328  that contains a specific active ingredient or active moiety and the sponsor uses the 
329  same proprietary name Drugname, with or without a modifier, to introduce a new 
330  product that does not contain the same active ingredient or active moiety. 
331  2.  A sponsor uses a portion of the proprietary name already associated with a marketed 
332  drug product (e.g., the use of a shared prefix letter string with a modified suffix letter 
333  string, whereby the prefix letter string evokes the proprietary name already associated 
334  with a marketed product), with or without a modifier, to introduce a new product that 
335  does not contain the same active ingredient or active moiety. 
336  Considering the many reports of confusion caused by brand name extension, FDA advises 
337  against using brand name extension to introduce a new nonprescription drug product.  
338  Consumers and health care professionals familiar with an existing nonprescription product, in 
339  some cases, equate that nonprescription products proprietary name with the products active 
340  ingredients (or active moieties) or uses. 
341  The use of the same proprietary name, or a portion of the same proprietary name, for products 
342  that do not share at least one active ingredient (or active moiety) with the original marketed 
343  product has been reported to cause confusion among consumers or health care professionals who 
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344  are familiar with the root proprietary name.25,26,27,28,29  The types of medication errors that have 
345  resulted from brand name extension confusion include the use of the wrong product, the use of a 
346  product for the wrong indication, the administration of an unnecessary or contraindicated active 
347  ingredient, and the use of a product in the wrong patient population, which in some cases has led 
348  to serious adverse events requiring hospitalization.30,31,32,33   In addition, familiarity with the 
349  product that originated the root proprietary name increases the risk that a consumer would not 
350  recognize that a nonprescription product sharing that proprietary name has a different use, dose, 
351  or safety profile than that of the original marketed product, as confirmation bias related to the 
352  proprietary name can make consumers less likely to focus on other aspects of the product label or 
353  labeling that would differentiate the products. 
354  B.  Family Branding (Family Trade Names) 
355  In this guidance, FDA uses the term family branding to refer to a naming strategy involving the 
356  use of the same root proprietary name to identify multiple products that share at least one active 
357  ingredient (or active moiety) in common with one another.  In this approach, the new product 
358  shares a root proprietary name with the original marketed product but adds a distinguishing 
359  suffix or modifier to distinguish the new product from the original marketed product.  This 
360  naming strategy results in the use of family trade names.  For example, the products marketed 
361  under the names, Mucinex, Mucinex DM, and Mucinex D, use a family branding strategy to 
362  market nonprescription drug products containing guaifenesin, utilizing the modifiers DM and 
363  D, to convey the additions of dextromethorphan and the decongestant pseudoephedrine to the 
364  formulation, respectively. 
365  Family trade names create a risk of medication errors if their modifiers do not adequately 
366  differentiate the products.  FDA recommends that sponsors consider the questions listed below to 
367  assess the risks of each proposed use of a family trade name in the proprietary name for a 
368  nonprescription drug product.  These are considerations FDA applies, on a case-by-case basis, 
369  when it evaluates a proposed use of a family trade name for a nonprescription product 
.
                                                 
25 Institute for Safe Medication Practices, 2014, Safety briefs: Another example of brand-name extension, ISMP 
Med Saf Alert Community/Ambulatory Care, 13(7):2-3. 
26 Institute for Safe Medication Practices, 2013, Safety briefs: Simply Saline simply isnt, ISMP Med Saf Alert 
Community/Ambulatory Care, 12(7):2-3. 
27 Institute for Safe Medication Practices, 2013, Allegra: Who knew it was also diphenhydrAMINE?, ISMP Med Saf 
Alert Community/Ambulatory Care, 12(4):4. 
28 Institute for Safe Medication Practices, 2009, Safety briefs: New brand-name extensions, ISMP Med Saf Alert 
Community/Ambulatory Care, 8(11):2-3. 
29 Institute for Safe Medication Practices, 2016, Safety Briefs: OTCs with similar names but totally different 
ingredients, ISMP Med Saf Alert Community/Ambulatory Care, 15(11):2-3. 
30 Institute for Safe Medication Practices, 2011, Safety briefs: Triaminic brand name extension could be dangerous 
to kids, ISMP Med Saf Alert Acute Care, 16(6):1-2. 
31 Institute for Safe Medication Practices, 2004, Safety Briefs: Cautions: Dulcolax brand name extensions, ISMP 
Med Saf Alert Acute Care, 9(7):1-2. 
32 FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products.  
Available at: 
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199476.htm . 
Accessed 4/15/19. 
33 Institute for Safe Medication Practices, 2010, Maalox Total Relief isnt the same great Maalox, ISMP Med Saf 
Alert Acute Care, 15(4):1-4. 
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370  Affirmative answers generally indicate lower risk associated with the family branding naming 
371  strategy. 
372    Does the proposed product share at least one active ingredient or active moiety with 
373  the first product marketed under the same root proprietary name? 
374    Are there no known issues of name confusion involving other marketed products 
375  using the same family trade name (see section C below)? 
376    Does the proposed modifier(s) adequately differentiate the proposed product from 
377  other members of the same family brand (see section III.A.5)? 
378    Do the results from name simulation studies, if conducted, support that the proposed 
379  name is not vulnerable to confusion with similar names (see section III.B.1)? 
380    Are the products within the family brand well-differentiated by other aspects of 
381  labeling (e.g., carton, container, DFL)? For example: 
382  o  Are differences in active ingredients (or active moieties), uses, dosage, and safety 
383  profile prominently displayed on the PDP of the carton or container closure 
384  system to assist in differentiation? 
385  o  Are enhanced fonts, boxing, color, or other means used to call attention to the 
386  pertinent product differences among products within a family brand? 
387    Is the proposed proprietary name, including the proposed modifier(s), unlikely to 
388  contribute to other legal concerns under the FD&C Act about the product (see section 
389  III.C)? 
390  FDA generally intends to consider any supporting data that are provided by the sponsor to 
391  describe the risks, or lack thereof, related to these points when determining the acceptability of a 
392  proposed use of a family trade name as part of the review of a premarket application. 
393  C.  Obtaining Medication Error Data for Names That Are Already Associated With 
394  Marketed Products 
395  Case reports of medication errors related to proprietary names that are already associated with 
396  marketed products can help inform the analysis of a proposed proprietary name.  FDA monitors 
397  medication error reports to identify cases of name confusion with the goal of identifying relevant 
398  information about the causes of problems and failures that lead to medication error, and the 
399  Agency applies any relevant information to the evaluation of a proposed proprietary name.  FDA 
400  recommends that sponsors obtain medication error report information from their internal safety 
401  databases, publicly available FDA Adverse Event Reporting System (FAERS) data,34 published 
402  literature, and resources available through patient safety organizations, such as ISMP. 
403  V.  RECOMMENDATIONS FOR DRUG PRODUCTS SWITCHING FROM 
404  PRESCRIPTION TO NONPRESCRIPTION USE  
405  In some cases, a drug sponsor will submit either a supplement to an approved application or a 
406  new NDA, seeking to switch a drug product that has been previously approved and marketed 
                                                 
34 Available at 
https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects. 
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407  for prescription use only, to permit marketing of a nonprescription product (see 21 CFR 
408  310.200(b)).  In such a case, the sponsor might or might not propose a proprietary name for the 
409  nonprescription product that is the same as the original prescription product proprietary name.  
410  FDA evaluates these proposals on a case-by-case basis, and generally considers the factors 
411  outlined below. 
412  A.  Full Prescription-to-Nonprescription Switch 
413  Sometimes an application for a full switch will be approved, so that all indications, dosage 
414  forms, strengths, etc. previously approved under that application for prescription-only use will 
415  now be available without a prescription, and no prescription product covered by that application 
416  will remain in the market.  In these cases, continued use of the original proprietary name for the 
417  new nonprescription product is likely to be acceptable unless the switch to nonprescription status 
418  introduces new safety or legal concerns resulting from the use of the name, consistent with the 
419  discussion in this guidance. 
420  Alternatively, the sponsor may elect to market the product under the original proprietary name 
421  with a modifier or propose a novel proprietary name for the nonprescription product (see section 
422  III). 
423  B.  Partial Prescription-to-Nonprescription Switch 
424  In certain cases, some of a products indications, dosage forms, or strengths previously available 
425  only by prescription are switched to nonprescription availability though others remain available 
426  by prescription only.  When this occurs, use of a proprietary name for the nonprescription 
427  product that is identical to that of the prescription product would make it difficult for end users to 
428  distinguish between the two products and could contribute to medication errors.  However, it 
429  may be possible to mitigate the risk of medication error by marketing the nonprescription 
430  product under a modified proprietary name.  Alternatively, the sponsor may elect to propose a 
431  novel proprietary name for the nonprescription product (see section III). 
432  VI.  CONCLUSION 
433  In conclusion, FDAs recommendations in this guidance are intended to help sponsors avoid 
434  choosing a proprietary name that is likely to contribute to medication errors or otherwise 
435  contribute to violations of the FD&C Act.  In evaluating a proposed proprietary name, FDA 
436  considers the information and analyses about the proposed proprietary name described in this 
437  guidance, along with any additional name-related information submitted by the sponsor. 
438  Assessments of a proprietary name are necessarily fact-specific and thus FDAs determinations 
439  are made on a case-by-case basis, considering the totality of the information. 
440     
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441   
442  GLOSSARY 
443  The following terms are described only to assist in understanding how they are used in this 
444  guidance: 
445  Active ingredient:  An active ingredient is any component that is intended to furnish 
446  pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or 
447  prevention of disease, or to affect the structure or any function of the body of man or other 
448  animals.  The term includes those components that may undergo chemical change in the 
449  manufacture of the drug product and be present in the drug product in a modified form intended 
450  to furnish the specified activity or effect.  See also 21 CFR 314.3(b).   
451  Active moiety:  Active moiety means the molecule or ion, excluding those appended portions of 
452  the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or 
453  coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of 
454  the molecule, responsible for the physiological or pharmacological action of the drug substance. 
455  See also 21 CFR 314.3(b). 
456  Brand name extension:  FDA uses the term brand name extension to refer to a naming practice 
457  that uses a proprietary name that is already associated with one or more marketed drug products, 
458  with or without a modifier, for a product that does not share any active ingredient(s) or active 
459  moiety(ies) with the marketed product(s). 
460  Confirmation bias:  Confirmation bias is the tendency to search for, interpret, favor, and recall 
461  information in a way that confirms one's preexisting beliefs or hypotheses. 
462  Container closure system:  A container closure system refers to the sum of packaging 
463  components that together contain and protect the dosage form.  This includes primary packaging 
464  components and secondary packaging components, if the latter are intended to provide added 
465  protection to the drug product.  A packaging system is equivalent to a container closure system. 
466  Drug Facts Labeling (DFL):  The drug facts labeling refers to the title, headings, subheadings, 
467  and information required under or otherwise described in  201.66(c). See 21 CFR 201.66(c). 
468  End user:  The term end user includes, but is not limited to, the consumer, the patient, patients 
469  caregiver, the prescribing physician, nurse, pharmacist, pharmacy technician, and other 
470  individuals who are involved in routine selection, purchase, procurement, stocking, storage, 
471  prescribing, dispensing, and administration of nonprescription drug products (e.g., medication 
472  technicians). 
473  Established name:  Section 502(e)(3) of the FD&C Act (21 U.S.C. 352(e)(3)) states that: 
474  the term established name, with respect to a drug or ingredient thereof, means (A) the 
475  applicable official name designated pursuant to section 508, or (B) if there is no such 
476  name and such drug, or such ingredient, is an article recognized in an official 
477  compendium, then the official title thereof in such compendium, or (C) if neither clause 
478  (A) or clause (B) of this subparagraph applies, then the common or usual name, if any of 
479  such drug or such ingredient, except that where clause (B) of this subparagraph applies to 
480  an article recognized in the United States Pharmacopeia and in the Homeopathic 
481  Pharmacopoeia under different official titles, the official title used in the United States 
482  Pharmacopeia shall apply unless it is labeled and offered for sale as a homeopathic drug, 
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483  in which case the official title used in the Homeopathic Pharmacopoeia shall apply 
484  [emphasis added]. 
485  Family trade name:  A family trade name results from a naming practice involving the use of a 
486  shared proprietary name to market multiple products with a shared active ingredient, using a 
487  suffix or modifier, to distinguish the products from one another.  This practice is also referred to 
488  as family branding. 
489  Label:  As defined in section 201(k) of the FD&C Act (21 U.S.C. 321(k)), the term label means 
490  a display of written, printed, or graphic matter upon the immediate container of any article.  If 
491  any word, statement, or other information is required by the FD&C Act to appear on the label, it 
492  must appear on the outside container or wrapper, if there is one, or be easily legible through the 
493  outside container or wrapper. 
494  Labeling:  As defined in section 201(m) of the FD&C Act, the term labeling means all labels 
495  and other written, printed, or graphic matter (1) upon any article or any of its containers or 
496  wrappers, or (2) accompanying such article. 
497  Medication error:  A medication error is any preventable event that may cause or lead to 
498  inappropriate medication use or medication-related patient harm while the medication is in the 
499  control of the health care professional, patient, or consumer.  Such events may be related to 
500  professional practice, health care products, procedures, and systems, prescribing, order 
501  communication, product labeling, packaging, and nomenclature, compounding, dispensing, 
502  distribution, administration, education, monitoring, and use. (See also National Coordinating 
503  Council for Medication Error Reporting and Prevention, available at 
504  https://www.nccmerp.org/about-medication-errors, accessed on 07/20/2020.) 
505  Modifier:  A modifier is a portion of the proprietary name.  Some proprietary drug names are 
506  constructed of a root proprietary name and added word(s) or other components that are referred 
507  to as the modifier portion of the proprietary drug name.  The modifier portion of a proprietary 
508  drug name might be a letter, number, word, device name, or combination of letters, numbers, and 
509  words appearing at the beginning or end of a root proprietary name, typically set off by a space 
510  or hyphen. 
511  Novel proprietary name: A proprietary name that has not been previously used in the United 
512  States for any marketed prescription or nonprescription human drug product. 
513  Official compendium:  The term official compendium is defined in section 201(j) of the FD&C 
514  Act as the official United States Pharmacopeia, official Homeopathic Pharmacopoeia of the 
515  United States, official National Formulary, or any supplement to any of them. 
516  Packaging:  A package or market package refers to the container closure system and labeling, 
517  associated components (e.g., dosing cups, droppers, spoons), and external packaging (e.g., 
518  cartons or shrink wrap).  A market package is the article provided to a pharmacist or retail 
519  customer upon purchase and does not include packaging used solely for the purpose of shipping 
520  such articles. 
521  Prefix:  A prefix is a group of letters that appears at the beginning of the proprietary name. 
522  Principal display panel (PDP):  The term principal display panel, as it applies to over-the-
523  counter drugs in package form, means the part of a label that is most likely to be displayed, 
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524  presented, shown, or examined under customary conditions of display for retail sale. See 21 CFR 
525  201.60.   
526  Proper name:  For biological products, the term proper name means the nonproprietary name 
527  designated by FDA in the license for a biological product licensed under the PHS Act.  See 21 
528  CFR 600.3(k). 
529  Proprietary name:  The proprietary name of a drug product is its brand name.35 
530  Root proprietary name:  Some proprietary names are constructed of multiple components. 
531  When a proprietary name contains a modifier as one of the components, the non-modifier portion 
532  of the proprietary name is referred to as the root proprietary name.  The root proprietary name 
533  may be shared by multiple products.  An example of a root proprietary name for a 
534  nonprescription drug product is Advil in Advil PM. 
535  Serious adverse event:   A serious adverse event is defined as an event that does or has the 
536  potential to result in death, hospitalization, congenital abnormality, permanent disability, or 
537  could be life-threatening. See 21 CFR 314.80 and Section 760(a)(3) of the FD&C Act, 21 U.S.C. 
538  379aa(a)(3). 
539  Suffix:  A suffix is a group of letters that appears at the end of the proprietary name. 
540     
                                                 
35 Sometimes referred to as the products trade name 
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Appendix A:  Examples of Previously Used Nonprescription Drug 
541 
Modifiers and Their Commonly Understood Meanings 
542 
543   
544   
Modifiers  Commonly Understood Meaning 
Allergy  For treatment of allergy symptoms 
D  Contains a decongestant 
PM  For nighttime use 
DM  Contains dextromethorphan 
For Men  For use only in men 
For Women  For use only in women 
12h  Dosed every 12 hours 
24h  Dosed every 24 hours 
545   
546   
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