General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

Drugs and drug products not labeled in compliance with applicable statutory and regulatory requirements may be misbranded and subject to enforcement action under the Federal Food, Drug, and Cosmetic Act. This information collection sets forth labeling required by the applicable authorities and supports FDA implementation of the attendant reporting, recordkeeping, and disclosure activities.

The latest form for General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions expires 2028-07-31 and can be found here.

Format & content for new OTC drug products (included FDA recommendations on statutory requirements)

Federal Enterprise Architecture: Health - Consumer Health and Safety