U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Contact Us
  1. Over-the-Counter OTC | Nonprescription Drugs

Contact Us

Over-the-Counter OTC | Nonprescription Drugs

Regulation of OTC products

Marketed under OTC Monographs
(All Categories)

Toll Free
(855) 543-3784, or
(301) 796-3400
druginfo@fda.hhs.gov

Registration and Listing of OTC drug products

Please visit Drug Registration and Listing System (DRLS & eDRLS) or email edrls@fda.hhs.gov

Importing OTC drug products

Please visit Importation of Drugs or call 301-796-3130.

Manufacturing and Product Quality

Please call 301-796-3268. 

Back to Top