Product Name 
Placement, Size, and 
Prominence in 
Promotional Labeling 
and Advertisements  
Guidance for Industry 
 
   
 
 
 
 
 
 
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) 
Center for Veterinary Medicine (CVM) 
 
 
December 2017 
Advertising 
 
 
 
OMB Control Number 0910-0686 
Expiration Date:  08/31/2024 
(Note:  OMB control number and expiration date added 09/29/2021) 
See additional PRA statement in section IV of this guidance. 
  Product Name Placement, 
Size, and Prominence in 
Promotional Labeling and 
Advertisements  
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 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave, Bldg. 71, Room 3128 
Silver Spring, MD  20993-0002 
Phone:  800-835-4709 or 240-402-8010 
Email:  ocod@fda.hhs.gov 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm 
and/or 
Policy and Regulations Staff, HFV-6 
Center for Veterinary Medicine 
Food and Drug Administration 
7519 Standish Place, Rockville, MD  20855 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm 
 
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) 
Center for Veterinary Medicine (CVM) 
 
December 2017 
Advertising  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION .............................................................................................................................................. 1 
II.  PRODUCTS WITH ONE ACTIVE INGREDIENT ....................................................................................... 2 
A.  JUXTAPOSITION OF PROPRIETARY AND ESTABLISHED NAMES ......................................................................... 2 
B.  SIZE OF PROPRIETARY AND ESTABLISHED NAMES ........................................................................................... 3 
C.  PROMINENCE OF PROPRIETARY AND ESTABLISHED NAMES ............................................................................. 4 
D.  FREQUENCY OF DISCLOSURE OF PROPRIETARY AND ESTABLISHED NAMES ..................................................... 4 
1.  Traditional Print Promotional Labeling and Advertisements .................................................................... 4 
2.  Audiovisual Promotional Labeling and Broadcast Advertisements ........................................................... 5 
3.  Electronic and Computer-Based Promotion ............................................................................................... 6 
III.  PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS .......................................................... 6 
IV.  PAPERWORK REDUCTION ACT OF 1995 ............................................................................................ 7 
 
  i  Contains Nonbinding Recommendations 
Product Name Placement, Size, and Prominence in Promotional 
Labeling and Advertisements 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
I.  INTRODUCTION  
 
This guidance clarifies the requirements for product name placement, size, prominence, and 
frequency2 in promotional labeling and advertisements for prescription drugs.3  The disclosure of 
the product name in promotional labeling and advertisements is important for proper 
identification and to ensure safe and effective use.  This guidance also articulates the 
circumstances under which FDA intends to refrain from taking enforcement action regarding 
these requirements.  We believe that following this guidance will allow for appropriate 
advertising and promotion without presenting any public health risk to patients.  
 
The Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research; the 
Office of Surveillance and Compliance in the Center for Veterinary Medicine; and the 
Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and 
Research frequently receive inquiries about the placement, size, prominence, and frequency of 
the proprietary name4 and established name5in promotional materials (promotional labeling and 
 
 
1 This guidance has been prepared by the Office of Prescription Drug Promotion in the Center for Drug Evaluation 
and Research in coordination with the Center for Biologics Evaluation and Research and the Center for Veterinary 
Medicine at the Food and Drug Administration. 
 
2 See 21 CFR 201.10(g) and (h) and 202.1(b), (c), and (d).  
  
3 For the purposes of this guidance, the term prescription drug means human prescription drugs, including 
prescription biological products, and animal prescription drugs.  With respect to biological products, the 
recommendations in this guidance apply to biological products that are approved for marketing under section 351 of 
the Public Health Service Act (PHS Act) and that are also regulated under the drug provisions of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act).  For such products, the provisions of the FD&C Act applicable to drugs also 
apply, as well as the regulations implementing these provisions, except that a biological product licensed under 
section 351 of the PHS Act is not required to have an approved new drug application under section 505 of the 
FD&C Act (21 U.S.C. 355).  See section 351(j) of the PHS Act (42 U.S.C. 262(j)).  This guidance does not apply to 
over-the-counter drugs. 
 
4 In this guidance, the term proprietary name refers to the trademark or brand name of a drug or biological product.  
The proprietary name is the exclusive name of a drug or biological product owned by a company under trademark 
law regardless of registration status with the United States. Patent and Trademark Office. The proprietary name for 
  1  Contains Nonbinding Recommendations 
advertisements).  Generally, the inquiries address two topics: (1) the juxtaposition of the 
proprietary and established names in relation to certain graphic presentations and (2) problems 
that stem from obscuring the presentation of or minimizing disclosure of the established name. 
 
The placement, size, prominence, and frequency of the proprietary and established names for 
prescription drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and 
(h) and 202.1(b), (c) and (d)).  These regulations are applicable to prescription drugs that contain 
one or more active ingredient(s). 
 
The recommendations in this guidance pertain to product names in traditional print media 
promotional labeling and advertisements (e.g., journal ads, detail aids, brochures), audiovisual 
promotional labeling (e.g., videos shown in a health care providers office), broadcast 
advertisements (e.g., television advertisements, radio advertisements), and electronic and 
computer-based promotions (e.g., internet, social media, emails, CD-ROMs, DVDs).  In this 
guidance, FDA further clarifies issues relating to the direct conjunction of the proprietary and 
established names, as well as the frequency of use of the established name on printed pages or 
spreads, in running text or columns, in the audio portion of audiovisual promotions, and in 
electronic media. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
  
 
II.  PRODUCTS WITH ONE ACTIVE INGREDIENT 
 
A.  Juxtaposition of Proprietary and Established Names 
 
For products with one active ingredient, the regulations describe when and how the established 
name must accompany the proprietary name in labeling and advertisements.  The regulations in 
21 CFR 201.10(g)(1) and 202.1(b)(1) state that: 
 
Where the established name is required to accompany or to be used in association with 
the proprietary name or designation, the established name shall be placed in direct 
conjunction with the proprietary name or designation, and the relationship between the 
 
prescription drug and biological products is proposed by the applicant and undergoes review and final approval by 
FDA. 
 
5 In this guidance, the term established name refers to both the established name of a drug product and to the proper 
name of a biological product.  The established name with respect to a drug product or ingredient thereof is the 
applicable official name designated pursuant to section 508 of the FD&C Act; or if there is no such official name, 
and such drug, or such ingredient, is an article recognized in an official compendium (such as the United States 
Pharmacopeia), then the official title thereof in such compendium; or if neither applies, the drug products or 
ingredients common or usual name (see 21 U.S.C. 352(e)(3)).  The proper name of a biological product is the name 
designated in the license for use upon each package of the product (21 CFR 600.3(k)). 
  2  Contains Nonbinding Recommendations 
proprietary name or designation and the established name shall be made clear by use of a 
phrase such as brand of preceding the established name, by brackets surrounding the 
established name, or by other suitable means.  (Emphasis added) 
 
FDA recommends that the established name be placed either directly to the right of or directly 
below the proprietary name.  FDA also recommends that the proprietary name and the 
established name not be separated by placement of intervening matter that would in any way 
detract from, obfuscate, or de-emphasize the established name of the product or obscure the 
relationship between the proprietary name and the established name.  For example, FDA 
recommends that the proprietary and established names not be separated by intervening matter, 
such as a logo, tagline, or other graphics.  Note:  FDA does not consider trademark symbols 
associated with proprietary names (e.g., registered trademark symbols () or unregistered 
trademark symbols (TM)) or controlled substance symbols (e.g., CII) to be intervening matter. 
 
Examples of appropriate juxtaposition include, but are not limited to, the following:   
 
 PROPRIETARY NAME (established name)  
 
6 PROPRIETARY NAMETM (established name) 
 
PROPRIETARY NAME CII  
(established name) 
 
B.  Size of Proprietary and Established Names 
 
When the established name is required to accompany the proprietary name in the running text of 
promotional labeling and advertisements, the regulations also require, in general, that the 
proprietary and established names be presented in the same type size (21 CFR 201.10(g)(1) and 
202.1(b)(1)).  FDA interprets the running text to mean the body of text in a promotional piece, as 
distinct from headlines, taglines, logos, graphs, or pictures.   
 
When the proprietary name is presented within the running text in larger-sized type than that of 
the surrounding running text, the established name is required to be printed at least once in letters 
that are at least half as large as the letters of the most prominent presentation of the proprietary 
name in such running text (21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2)).  In addition, 
when the proprietary name is presented outside the running text, such as in a headline, the 
established name is also required to be printed in letters that are at least half as large as the letters 
of the proprietary name within that designated section (e.g., headline) (21 CFR 201.10(g)(1) and 
(2) and 202.1(b)(1) and (2)). 
 
Please note that FDA interprets this type-size requirement to relate to actual size, not point size, 
of uppercase and lowercase letters in the proprietary and established names.  For example, in 
situations when the established name is required to be printed in letters at least half as large as 
the letters of the proprietary name, FDA recommends that the smallest letter of the established 
 
6 The symbol represents a logo or graphic representation. 
  3  Contains Nonbinding Recommendations 
name (upper- or lowercase letters) be printed in letters at least one half the actual size of the 
largest letter of the proprietary name (upper- or lowercase letters). 
 
C.  Prominence of Proprietary and Established Names 
 
The regulations require that the established name shall have a prominence commensurate with 
the prominence with which such proprietary name or designation appears, taking into account all 
pertinent factors, including typography, layout, contrast, and other printing features (21 CFR 
201.10(g)(2) and 202.1(b)(2)).  Generally, FDA considers all methods used to achieve 
prominence in promotional labeling or advertisements when evaluating whether the established 
name is presented with a prominence commensurate with that of the proprietary name.   
 
The following hypothetical examples7 of established name presentations do not have 
commensurate prominence with the proprietary names, considering factors such as contrast, type 
size, and spacing:   
 
 
 
 
D.  Frequency of Disclosure of Proprietary and Established Names 
 
The regulations in 21 CFR 201.10(g)(1) and 202.1(b)(1) state that: 
   
If an advertisement for [or the label or labeling of] a prescription drug bears a proprietary 
name or designation for the drug or any ingredient thereof, the established name, if such 
there be, corresponding to such proprietary name or designation shall accompany such 
proprietary name or designation each time it is featured in the advertisement [or on the 
label or in the labeling] for the drug . . . . On any page of an advertisement [or any label 
or page of labeling] in which the proprietary name or designation is not featured but is 
used in the running text, the established name shall be used at least once in the running 
text in association with such proprietary name or designation . . . . If any advertisement 
[or any labeling] includes a column with running text containing detailed information as 
to composition, prescribing, side effects, or contraindications and the proprietary name or 
designation is used in such column but is not featured above or below the column, the 
established name shall be used at least once in such column of running text in association 
with such proprietary name or designation . . . . (Emphasis added) 
 
1.  Traditional Print Promotional Labeling and Advertisements 
 
For traditional print promotional labeling and advertisements, the established name is required to 
accompany the proprietary name when the proprietary name is featured (e.g., headlines, taglines, 
logos, graphs, or pictures).  Although the regulations state that the established name shall 
 
7 The examples involve fictitious products and are not an endorsement of the fictitious product names.  
  
 
  4  Contains Nonbinding Recommendations 
accompany such proprietary name . . . each time it is featured, FDA does not intend to object to 
fewer appearances of the established name, provided that the established name accompanies the 
proprietary name at least once per page or spread8 where the proprietary name most prominently 
appears.  For example, if the established name follows the proprietary name in a headline, FDA 
does not intend to object if the established name does not also follow the proprietary name in 
sub-headlines, appear in the running text on the same page or spread, or appear in columns on 
the same page or spread.   
 
If the proprietary name is not featured but is only part of the running text, the established name is 
required to accompany the proprietary name at least once in the running text.  If the running text 
spans more than one page or spread, FDA recommends that the established name accompany the 
proprietary name at least once per page or spread.   
 
The regulations in 21 CFR 201.10(g)(1) and 202.1(b)(1) include information regarding the 
frequency of the proprietary and established names if columns are used in a promotional labeling 
piece or advertisement (e.g., a newspaper advertisement).  FDA interprets a column to mean one 
of two or more vertical sections of a printed page, separated by a rule or blank space.  If the 
proprietary name appears in more than one column of running text (but does not appear outside 
of the text, above or below the column), FDA does not intend to object, provided that the 
established name accompanies the proprietary name at least once per page or spread. 
 
2.  Audiovisual Promotional Labeling and Broadcast Advertisements 
 
Audiovisual promotional labeling (e.g., videos shown in a health care providers office) and 
audiovisual broadcast advertisements (e.g., television ads) do not contain text pages like print 
media.  However, promotional labeling and advertisements in such media often contain 
superimposed text or supers.  For superimposed text that is equivalent to a headline or tagline, 
FDA does not intend to object to fewer appearances of the established name if the established 
name is placed in direct conjunction with the most prominent display of the proprietary name in 
the audiovisual promotional labeling or broadcast advertisement.9  When the established name 
accompanies the proprietary name, FDA recommends that the established name be displayed on 
the screen for the same amount of time as the proprietary name.  For superimposed text that 
typically appears along the bottom of the screen, the established name does not have to be 
included with the proprietary name.  FDA does not intend to object if the established name is not 
included in the audio portion of audiovisual promotional labeling or in an audiovisual broadcast 
advertisement. 
 
For radio and telephone advertisements, FDA does not intend to object if the established name is 
disclosed in direct conjunction with the most prominent presentation of the proprietary name.  
Under most circumstances, this is the first occurrence in the broadcast. 
 
8 In this guidance, the term spread refers to adjacent pages of promotional material with related matter or connecting 
elements extending across the fold. 
 
9 When determining the most prominent display of the proprietary name, consideration should be given to all 
pertinent factors, including typography, layout, contrast, and other printing features, such as type size.  The most 
prominent display of the proprietary name is generally the largest display in audiovisual promotional labeling and 
broadcast advertisements. 
  5  Contains Nonbinding Recommendations 
 
3.  Electronic and Computer-Based Promotion 
 
Promotion in electronic and computer-based media also does not contain text pages like print 
media.  However, promotion in such media often contains information or running text equivalent 
to many pages of traditional printed text.  FDA does not intend to object to fewer appearances of 
the established name, provided that the established name accompanies the proprietary name at 
least once per web page where the proprietary name most prominently appears on the web 
page.10  However, if the proprietary name is not featured but is part of the running text, the 
established name is required to accompany the proprietary name at least once in the running text 
(21 CFR 201.10(g)(1) and 202.1(b)(1)).  Columns of running text should be treated similarly to 
columns on the printed page. 
 
 
III.  PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS 
 
A product with two or more active ingredients might not have a single established name 
corresponding to the proprietary name.  In such instances, the regulations in 21 CFR 
201.10(h)(1) and 202.1(c) state that: 
 
[T]he quantitative ingredient information required on the label by section 502(e) of the 
act [or in the advertisement by section 502(n) of the act] shall be placed in direct 
conjunction with the most prominent display of the proprietary name or designation.  
The prominence of the quantitative ingredient information shall bear a reasonable 
relationship to the prominence of the proprietary name. (Emphasis added) 
 
Similarly, a proprietary name might refer to a combination of active ingredients present in more 
than one preparation (e.g., individual preparations differing from each other as to quantities of 
active ingredients and/or the form of the finished preparation), and there might not be an 
established name corresponding to the proprietary name.  In such instances, the advertising 
regulations in 21 CFR 202.1(d)(1) provide that: 
 
[A] listing showing the established names of the active ingredients shall be placed in 
direct conjunction with the most prominent display of such proprietary name or 
designation.  The prominence of this listing of active ingredients shall bear a reasonable 
relationship to the prominence of the proprietary name and the relationship between such 
proprietary name or designation, and the listing of active ingredients shall be made clear 
by use of such phrase as brand of, preceding the listing of active ingredients. (Emphasis 
added) 
 
In both of these situations, FDA recommends that the active ingredients be placed either directly 
to the right of or directly below the proprietary name.  FDA also recommends that the 
proprietary name and the required information regarding the active ingredients not be separated 
 
10 When determining the most prominent display of the proprietary name, consideration should be given to the 
placement of the proprietary name and how the web page is displayed when viewed on different devices (e.g., 
desktop computer monitors, mobile devices, tablets).  The most prominent display of the proprietary name is 
generally near the top of the relevant web page when viewed on most electronic devices. 
  6  Contains Nonbinding Recommendations 
by placement of intervening matter that would in any way detract from, obfuscate, or de-
emphasize the active ingredients of the product or obscure the relationship between the 
proprietary name and the active ingredients.  For example, FDA recommends that the proprietary 
name and the required information regarding the active ingredients not be separated by 
intervening matter, such as a logo, tagline, or other graphics.  As noted in section II.A of this 
guidance, FDA does not consider trademark symbols associated with proprietary names (e.g., 
registered trademark symbols () or unregistered trademark symbols (TM)) or controlled 
substance symbols (e.g., CII) to be intervening matter.  
 
Examples of appropriate juxtaposition include, but are not limited to, the following: 
 
PROPRIETARY NAME (active ingredient 1 and active ingredient 2) 
 

 PROPRIETARY NAMETM (active ingredient 1 and active ingredient 2) 
 
PROPRIETARY NAME CII 
active ingredient 1/active ingredient 2 
 
The regulations described in this section also require that the presentation of the active 
ingredients bear a reasonable relationship to the prominence of the proprietary name (21 CFR 
201.10(h)(1) and 202.1(c)).  Thus, FDA recommends that the active ingredients be presented 
with a prominence commensurate with the prominence of the presentation of the proprietary 
name.  For example, if the proprietary name is printed in bold, black text against a white 
background, FDA recommends that the active ingredients be presented with commensurate 
emphasis and contrast. 
 
 
IV.  PAPERWORK REDUCTION ACT OF 1995  
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520).  The time required to complete this information collection is estimated to 
average 3 hours per disclosure.  Send comments regarding this burden estimate or suggestions 
for reducing this burden to:   
 
Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Silver Spring, MD 
20993-0002 
  7  Contains Nonbinding Recommendations 
This guidance also refers to previously approved collections of information found in FDA 
regulations.  The collections of information in 21 CFR 202.1 have been approved under OMB 
control number 0910-0686. 
 
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection 
of information unless it displays a currently valid OMB control number.  The OMB control 
number for this information collection is 0910-0686 (expires 08/31/2024 (Note:  OMB control 
number and expiration date added 09/29/2021)). 
 
 
  8