Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products

On 8 September 2022 the FDA published draft guidance on content and format of labeling for human nonprescription drug products. Submit comments by 8 November 2022.

This draft guidance provides recommendations on the labeling of human drug products for the content and format of the required statement of identity and the drug product’s strength.

The recommendations in this draft guidance are intended to help manufacturers, packers, distributors, applicants, re-labelers, and sponsors ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products.

Labeling for nonprescription drug products is intended to enable consumers to self-select appropriately and safely without the supervision of a health care practitioner.