Over 100,000 OTC drug products, which contain approximately 700 active ingredients, are currently marketed. OTC drug products are legally marketed in the United States as a result of two types of review by the FDA: OTC drug monograph review or new drug review.
The majority of currently marketed OTC drug products have been evaluated under the OTC drug monograph review. Under this review, the FDA evaluates the active ingredients in products after they have met certain marketing requirements to affirm that they are safe, effective, and properly labeled for their intended uses. This is an active ingredient review, rather than a product-by-product (new) drug review. As a result, the FDA publishes OTC drug monographs that list active ingredients, allowed combinations, and required labeling for classes of OTC drug products (e.g., antacids, cough-cold products). In general, to market an OTC product, the product must meet the standards of the OTC monograph. OTC monographs specify the allowable ingredients, labeling, dosage, etc. for OTC medications.
If the product differs from the OTC monograph, it is treated as a new drug. For new (and new generic) OTC drug products, review and approval of a product-specific New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) must occur before marketing is permitted. Products initially marketed as OTC drugs and products initially marketed as prescription (Rx) drug products may be approved under this new drug review.
