Format and Content Requirements for Over-the-Counter Drug Product Labeling

OMB 0910-0340

OMB 0910-0340

The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory requirements.

The latest form for Format and Content Requirements for Over-the-Counter Drug Product Labeling expires 2022-12-31 and can be found here.

OMB Details

Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)

Federal Enterprise Architecture: Health - Consumer Health and Safety


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