Guidance  for Industry 
Labeling of Nonprescription Human 
Drug Products Marketed Without an 
Approved Application as Required by the 
Dietary Supplement and Nonprescription 
Drug Consumer Protection Act: 
Questions and Answers 
U.S. Department of Health and Human 
Services Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
September 2009 
OTC 
OMB Control Number 0910-0340
Current expiration date available at https://www.reginfo.gov
(Search ICR and enter OMB control number)
See additional PRA statement in section IV of this guidance Guidance for Industry 
Labeling of Nonprescription Human 
Drug Products Marketed Without an 
Approved Application as Required by the 
Dietary Supplement and Nonprescription 
Drug Consumer Protection Act: 
Questions and Answers 
Additional copies are available from: 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 51, Room 2201 
Silver Spring, MD 20993-0002 
Phone: 301-796-3400; Fax: 301-847-8714; E-mail: druginfo@fda.hhs.gov 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
September 2009 
OTC  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND ............................................................................................................... 2
III. QUESTIONS AND ANSWERS ....................................................................................... 2 
IV. PAPERWORK REDUCTION ACT OF 1995 ................................................................ 5  Contains Nonbinding Recommendations 
1
Guidance for Industry
Labeling of Nonprescription Human Drug Products Marketed 
Without an Approved Application as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection 
Act:  Questions and Answers 
This guidance represents the Food and Drug Administration's (FDAs) current thinking on this topic. It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 
An alternative approach may be used if such approach satisfies the requirements of the applicable statutes 
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate  
number listed on the title page of this guidance. 
I. INTRODUCTION
This document is intended to assist industry in complying with the labeling requirements of the 
Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 
120 Stat. 3469). The statute created a new section 502(x) in the Federal Food, Drug, and 
Cosmetic Act (the Act) (21 U.S.C. 352(x)). These requirements apply to manufacturers, packers, 
and distributors of nonprescription (over-the-counter (OTC)) human drug products marketed 
without an approved application.  In particular, this document covers the following topics: (1) 
the meaning of domestic address for purposes of the labeling requirements of section 502(x) of 
the Act, (2) FDAs recommendation for the use of an introductory statement before the domestic 
address or phone number that is required to appear on the product label under section 502(x) of 
the Act, and (3) FDAs intent regarding enforcing the labeling requirements of section 502(x) of 
the Act. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's 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. 
1 This guidance has been prepared in the Center for Drug Evaluation and Research (CDER) at the Food and Drug 
Administration. 
1  Contains Nonbinding Recommendations 
II. BACKGROUND
Public Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer Protection 
Act, was signed by the President on December 22, 2006.2   Public Law 109-462 amends the Act 
to add reporting, recordkeeping, and labeling requirements for OTC drug products that are 
marketed without an approved application under section 505 of the Act (21 U.S.C. 355).3    This 
guidance document contains questions and answers relating to these new labeling requirements. 
III. QUESTIONS AND ANSWERS
Q1:  What information must be included on the label of an OTC drug marketed without an 
approved application for purposes of complying with section 502(x) of the Act? 
Section 2(d) of Public Law 109-462 adds section 502(x) to the Act to require the label of an OTC 
drug marketed in the United States without an approved application to include a domestic 
address or domestic phone number through which the responsible person [i.e., the manufacturer, 
packer, distributor, or retailer identified on the drug label] ... may receive a report of a serious 
adverse event associated with the use of the drug product.  If the label does not include the 
required domestic address or phone number, the drug is misbranded. 
When the responsible person chooses to provide a domestic address (rather than a domestic 
phone number) for adverse event reporting, FDA concludes that the statute requires the product 
label to bear a full U.S. mailing address that includes the street address or P.O. Box, and the city, 
state, and zip code of the responsible person.  FDA finds that Congresss use of the term 
domestic address in section 502(x) of the Act is a clear and unambiguous directive that labels of 
OTC drug products marketed without an approved application include all information necessary 
to enable a serious adverse event report to reach the responsible person. This reading of section 
502(x) of the Act is supported by dictionary definitions of address, which include the indication 
of destination, as on mail or parcels and the location at which a person or an organization may 
be reached.4   Indeed, an address does not serve its intended purpose unless it includes all the 
information necessary to enable mail to reach its destination. 
Similarly, when the responsible person chooses to provide a domestic phone number for adverse 
event reporting, FDA concludes that the statute requires the phone number on the product label 
to include the area code (e.g., a toll-free area code such as 800 or a local area code such as 301). 
Without the area code, the phone number is incomplete and does not serve its intended purpose 
of enabling the consumer to contact the responsible person to report a serious adverse event. 
2 Available on the Internet at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm102797.pdf. 
3 Section 760 of the Act (21 U.S.C. 379aa), as amended, provides for mandatory safety reporting for OTC human 
drug products not subject to applications approved under section 505 of the Act (new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs)). Accordingly, these new requirements apply to all OTC drug products 
marketed without an approved application, including those marketed under the OTC Drug Monograph Review 
process (whether or not subject to a final monograph) and those marketed outside the monograph system. 
4 Websters II New Riverside University Dictionary (Houghton Mifflin 1984), p. 77. 
2    Contains Nonbinding Recommendations 
 
 
Congresss use of the phrase through which the responsible person ... may receive a report to 
modify domestic address or domestic phone number further supports FDAs conclusion that 
domestic address or domestic phone number means a complete address or phone number (see 
section 502(x) of the Act). This phrase shows Congresss intent that the domestic address or 
domestic phone number on the label be sufficient to ensure that the responsible person will 
actually receive the serious adverse event reports that consumers submit.  If the address provided 
on the product label for adverse event reporting is incomplete (e.g., no street address or P.O. 
Box), it is likely that some of the serious adverse event reports that are submitted to the 
responsible person by mail will not be received.  In addition, when consumers notice the 
incomplete address, they might decide not to submit a report to the responsible person because 
they believe it will not be received. Similarly, if the phone number provided on the product label 
for adverse event reporting does not include an area code, there is no assurance that consumers 
will be able to connect to the responsible person. 
 
The use of the term domestic address in section 502(x) of the Act contrasts with Congresss use 
of a different term, place of business in section 502(b) of the Act. Section 502(b) of the Act 
provides that a drug is misbranded unless the product label bears the name and place of business 
of the manufacturer, packer, or distributor. FDA regulations interpret place of business to 
require only city, state, and zip code to appear on the product label, as long as the street address 
is listed in a current telephone directory or other city directory (21 CFR 201.1(i)). The use of the 
term domestic address in section 502(x) of the Act demonstrates Congresss intent to require the 
responsible persons full address, including the street address or P.O. Box, to appear on the label 
when the responsible person has opted to receive serious adverse event reports by mail.  If 
Congress had considered the less complete, place of business address already required in  
201.1(i) of the regulations to be adequate for serious adverse event reporting, there would have 
been no need to impose a new, more specific requirement in section 502(x) of the Act for the 
responsible persons domestic address to appear on labels. 
 
Q2: Should the label of an OTC drug marketed without an approved application include 
language indicating that the purpose of the domestic phone number or domestic address is to 
report serious adverse events associated with the use of the product? 
 
Although section 502(x) does not require the label to include anything other than a domestic 
phone number or domestic address for the responsible person, FDA recommends that the label 
bear a clear, prominent statement informing consumers that the domestic phone number or 
domestic address is for reporting serious adverse events associated with use of the product. 
Such a statement can also be used to clarify that a doctor should be called for medical advice. 
 
As stated in FDAs Drug Facts regulations (21 CFR 201.66(c)(9)), the labels of OTC drug 
products may include a telephone number as a source to answer questions about the product, 
with the heading Questions? or Questions or comments?. These regulations state that a graphic 
of a telephone or telephone receiver may appear before the heading and recommend that the 
label also include a statement about the days of the week and times of the day when a person is 
available to respond to questions. 
  3  Contains Nonbinding Recommendations 
When the responsible person chooses to provide a domestic phone number (rather than a 
domestic address) to satisfy the labeling requirement of section 502(x) of the Act, and if the 
responsible person decides to provide a clarifying statement, the phone number and clarifying 
statement can be included in one of the following ways: 
 Under the Questions? or Questions or comments? heading described in 21 CFR
201.66(c)(9).  The responsible person can use the same telephone number described in 
201.66(c)(9) for product questions or comments to receive reports of adverse events,
assuming that the responsible person has in place the personnel and procedures to receive
such reports through this phone number. With this option, FDA recommends that the
responsible person include the clarifying statement after the telephone number to
emphasize that the same number can be used for asking questions, submitting comments,
or reporting adverse events; for example, You may also report serious side effects to this
phone number. Alternatively, the responsible person can include the clarifying
statement under the Other Information heading described in  201.66(c)(7), with a
reference to the telephone number under Questions or comments?, such as You may
report serious side effects to the phone number provided under Questions? below.
 Under the Other Information heading. The responsible person can include a phone
number and clarifying statement, such as You may report serious side effects to [insert
phone number].
 Outside of Drug Facts.  The responsible person can include the phone number and
clarifying statement in another location on the label, such as the location that identifies
the manufacturers place of business; for example, You may report serious side effects
to [insert phone number].
When the responsible person chooses to provide a domestic address (rather than a domestic 
phone number), regardless of whether the address is introduced with a prefatory statement, the 
full address should be included either (1) under the Other Information heading, or (2) outside of 
Drug Facts, such as the location on the label that identifies the manufacturers place of 
business.5  Under these circumstances, FDA recommends that the label include an introductory 
statement, such as You may report serious side effects to: [insert street address or P.O. Box, 
city, state, and zip code]. 
Responsible persons can provide on the product label an e-mail address or Web site to which 
reports can be made, provided that such e-mail address or Web site is in addition to the domestic 
phone number or domestic address required by section 502(x) of the Act. 
Q3:  When do the labeling requirements in section 502(x) of the Act become effective? 
Under section 1(e)(2) of Public Law 109-462, the labeling requirements of section 502(x) of the 
Act became effective on December 22, 2007, one year after the date of the law's enactment. 
5 In this case, the full address satisfies the labeling requirements in sections 502(x) and 505(b)(1) of the Act, as 
defined further in 21 CFR 201.1(i). 
4  Contains Nonbinding Recommendations 
Therefore, these labeling requirements are already in effect.  However, this guidance sets forth 
FDA's intention to exercise enforcement discretion for the new labeling requirements until 
September 30, 2010.  This period of enforcement discretion should be adequate to enable all 
firms to meet the labeling requirements.  Therefore, FDA intends to begin enforcing the labeling 
requirements of section 502(x) of the Act for OTC drug products marketed without an approved 
application that are labeled on or after September 30, 2010. 
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 4 hours per 
response, including the time to review instructions, search existing data sources, gather the data 
needed, and complete and review the information collection. Send comments regarding this 
burden estimate or suggestions for reducing this burden to: 
Office of Nonprescription Products 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave. 
WO22- 5488 
Silver Spring, MD 20993-0002 
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 0910-0340. The current expiration date is available at https://reginfo.gov (search ICR and enter 
OMB control number).
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