Small Business Assistance: Over-the-Counter (OTC) Drug Product Review Process

Over-the-counter drugs are defined as drugs that are safe and effective for use by the general public without a prescription.

• Drug Applications for Over-the-Counter Drugs.  Links to information about OTC labeling and warning, guidances, Federal Register publications, and more.

• Frequently Asked Questions on the Regulatory Process of OTC Drugs (4/5/2004)