Description
This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products who have questions about the standardized labeling content and format requirements set forth in 21 CFR 201.66.
Scope & Applicability
Product Classes
5Guidance provides a framework for over-the-counter drug products.
Products granted a stay of compliance for Drug Facts regulation
The Drug Facts labeling regulation covers all OTC drug and drug-cosmetic products; Products containing both drug and cosmetic ingredients
products that are both drugs and cosmetics
Nonprescription drug products subject to the monograph system.
Stakeholders
3manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws
Firms responsible for drug and device promotion
entities involved in the distribution of devices
Regulatory Context
Attributes
7Required heading in Drug Facts labeling
Required label element for outsourcing facilities
default format for Drug Facts
Format used when Drug Facts content requires more than 60 percent of surface area
Required heading in Drug Facts labeling
Instructions for use based on age or population
minimum type size for numerical notation of fractions and sub-bullets
Related CFR Sections (13)
- 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →
- 21CFR330.1§ 330.1 General conditions for general recognition as safe, effective and not misbranded.
An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the cRead full regulation →
- 21CFR211.132§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
(a) General. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and eRead full regulation →
- 21CFR201.20§ 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
(a) The label for over-the-counter and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 as a color additive using the names FD&C Yellow No. 5 and tartrazine. The labeling for over-tRead full regulation →
- 21CFR201.62§ 201.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter drug in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination or numerical count and weight, measure, or size. The statement of quantity of drugs in tabletRead full regulation →
- 21CFR201.61§ 201.61 Statement of identity.
(a) The principal display panel of an over-the-counter drug in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR201.60§ 201.60 Principal display panel.
The term principal display panel, as it applies to over-the-counter drugs in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall beRead full regulation →
- 21CFR201.18§ 201.18 Drugs; significance of control numbers.
The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded.Read full regulation →
- 21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers Read full regulation →
- 21CFR201.1§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
(a) A drug or drug product (as defined in § 320.1 of this chapter ) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply toRead full regulation →
- 21CFR201.320§ 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
- 21CFR352.52§ 352.52 Labeling of sunscreen drug products.
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “sunscreen.”Read full regulation →
- 21CFR701.3§ 701.3 Designation of ingredients.
(a) The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which is both fragrance and flavor shall be designated by each of the functionsRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
See Also (8)
- Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for Industry (Status: Final)
- Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry (Status: Final)
- Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Labeling OTC Human Drug Products Using a Column Format (Status: Final)
- Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (Status: Final)
- Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (Status: Draft)
- Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (Status: Final)