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# Nonprescription Drug Label Guidance
- URL: https://www.fdaweb.com/nonprescription-drug-label-guidance/
- Published: 2022-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:58:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152688

FDA has published a draft guidance, *Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products*, with labeling recommendations intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statement-identity-and-strength-content-and-format-labeling-human-nonprescription-drug-products?ref=fdaweb.com) says labeling for nonprescription drug products “is intended to enable consumers to self-select appropriately and use the nonprescription drug product safely and effectively without the supervision of a healthcare practitioner…. The statement of identity is one of the principal features on nonprescription drug product labeling and consists of the established name for the nonprescription drug product, if one exists, followed by an accurate statement of the general pharmacological category(ies) or the principal intended action(s) of the drug product.”

The draft says the labeling of all nonprescription drug products must display the statement of identity on the product’s principal display panel (PDP). “Consistent content and format of the statement of identity and strength on the PDP may aid consumers in comparing nonprescription drug products and assist consumers in appropriate self-selection,” it says.

Access an agency explanatory post about the guidance [here](https://www.fda.gov/drugs/drug-safety-and-availability/fda-draft-guidance-aims-improve-consistency-labeling-nonprescription-drugs?utm%5Fmedium=email&utm%5Fsource=govdelivery).