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In this section: 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.

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