Regulation of OTC products

Marketed under OTC Monographs
(All Categories)

Toll Free
(855) 543-3784, or
(301) 796-3400
[email protected]

Registration and Listing of OTC drug products

Please visit Drug Registration and Listing System (DRLS & eDRLS) or email [email protected]

Importing OTC drug products

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

Manufacturing and Product Quality

Please call 301-796-3268.