Over-the-Counter (OTC) | Nonprescription Drugs

Nonprescription (or over-the-counter) drugs are available to consumers without a prescription. They can be safely and effectively used without the supervision of a healthcare provider. Nonprescription drugs have long provided an efficient, accessible way for Americans to manage everyday health needs and they play an increasingly vital role in our healthcare system. The vast array of nonprescription drugs include cough and cold medications, fever reducers, sunscreens, pain relievers, antacids, and many more. 

This page describes how FDA regulates nonprescription drugs and offers resources to the public. Consumers seeking general information about the safe use of nonprescription drugs may visit our consumer website.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act includes provisions that governs and modernizes the way certain over-the-counter (OTC) drugs are regulated in the United States. Learn more about the CARES Act and OTC monograph reform.

Industry Resources

Historical Status of OTC Rulemakings

This is an industry resource of historical rulemakings related to nonprescription drugs.

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

Guidances

Search for guidances using the terms “nonprescription” and/or “over-the-counter”

Pathways to Market

OTC Monographs @ FDA

The primary place to access information about OTC monograph drugs since the passage of the CARES Act, including OTC Monographs and Administrative Orders

OTC Drug Review Process | OTC Drug Monographs

There are two regulatory pathways for nonprescription drugs to come to market: the drug application process and the OTC drug monograph process

Drug Application Process for Nonprescription Drugs

Varied options exist within the drug application process to bring new drugs to market as a nonprescription drug

Nonprescription Drug Product with an ACNU

A pathway intended to increase nonprescription drug options for consumers

Rx to NonRx Switch List

The list includes both full and partial switches from prescription to nonprescription marketing status

User Fee Information

Over-the-Counter Monograph User Fees

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

OMUFA Reauthorization: Fiscal Years 2026 – 2030

This page includes all information pertaining to the latest OMUFA commitment

FDA User Fee Programs

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

Industry Engagement Related to Nonprescription Drugs

Sunscreen Meetings

A list of meetings that have occurred between FDA and stakeholders on the topic of sunscreens

Topical antiseptic drug products

Information on FDA’s ongoing review of antiseptic active ingredients

Antiseptic meetings

A list of meetings that have occurred between FDA and stakeholders on the topic of antiseptics

Antiseptic FDA Letters

A list of correspondence that have occurred between FDA and stakeholders on the topic of antiseptics

Information for Consumers

Understanding Over-the-Counter Medicines

Landing page for varied OTC drug information for consumers

Prescription and OTC Drugs

Frequently asked Questions and Answers

OTC Drug Facts Label

FDA requires a standard label of important drug information for all nonprescription drug products

Contact Us

Division of Drug Information (DDI)

Contact DDI, which serves as the central resource for drug information and regulatory support