About OTC Monographs@FDA

OTC Monographs@FDA provides a resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs. OTC Monographs@FDA also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified.

OTC Monographs@FDA also facilitates the submission of comments and data from stakeholders, including both individuals and organizations, for Proposed or Interim Final Administrative Orders.

OTC Monographs@FDA provides resources and information about the regulation of OTC monograph drugs. Frequently Asked Questions