[9/8/2022] FDA announced the availability of a draft guidance titled “Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products,” which provides recommendations on the content and format of the required statement of identity and the drug’s strength, which both appear on the labeling of human nonprescription drug products. The recommendations in this guidance are intended to help manufacturers, packers, distributors, applicants, relabelers, and sponsors ensure consistent content and format of the statement of identity and strength for all nonprescription drug labeling. Consumers use nonprescription drugs without the supervision of a health care professional. The nonprescription drug’s label is intended to empower consumers to appropriately select and use the product safely and effectively.
One of the prominent features required to be on the principal display panel (PDP) of the drug product is the statement of identity. The PDP, often the front panel of the label, is the part of the nonprescription drug’s label most likely to be displayed to the consumer in retail sale. The statement of identity consists of the drug’s established name, if it has one, followed by an accurate statement of the general pharmacological category(ies) or the drug’s principal intended action(s) (for example, “clotrimazole cream, antifungal”). This information tells the consumer what the drug is and its intended use. The drug strength is also often found on the PDP. Consistent content and format of the statement of identity and drug strength may aid consumers in comparing different nonprescription drugs and assist consumers in selecting an appropriate product.