Over-the-Counter OTC | Nonprescription Drugs

On June 27, 2022, the FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. For more information, see The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use.

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.

Industry Resources

OTC Monographs @ FDA

A resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs.

Drug Application Process for Nonprescription Drugs

FDA reviews active ingredients and labeling of over 80 therapeutic classes of drugs

OTC Drug Review Process | OTC Drug Monographs

Three-phase public rulemaking process resulting in the establishment of standards for an OTC therapeutic drug class

Status of OTC Rulemakings

Research aid for OTC rulemaking history

Small Business Assistance

Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs

Regulatory Information for OTC Drugs

Federal Register Notices, Ingredient References, and other Regulatory Information

Enforcement Activities | OTC Drugs Branch

Minimizes risk to consumers from OTC drug products

Guidances related to Over-the-Counter Drugs

Search "Over-the-Counter Drugs"

Additions/Deletions for Prescription and OTC Drug Product Lists

Use in conjunction with current Cumulative Supplement and Orange Book

User Fee Programs

Over-the-Counter Monograph User Fees

Supports timely and efficient FDA review of the efficacy and safety of ingredients

FDA User Fee Programs

Helps FDA fulfill its mission of protecting the public health and accelerating innovation in the industry

Meetings related to OTC Drugs

Sunscreen meetings

Antiseptic meetings

Information for Consumers

Understanding Over-the-Counter Medicines

Also known as OTC or nonprescription medicine you can buy without a prescription

Prescription and OTC Drugs

Frequently asked Questions and Answers

Contact Us

Regulation, registration and listing, importing, manufacturing and product quality of OTC products