A mouthwash marketed only to freshen breath is a cosmetic. One claiming to kill germs that cause gingivitis, or to reduce plaque, is an OTC drug subject to the FDA's antiseptic mouthwash monograph. The label's therapeutic claims are the determining factor, so importers should review all on-pack language — including foreign-language text — before finalizing the regulatory pathway.

Because fluoride toothpaste is an OTC drug, importers should be prepared to provide evidence of OTC monograph compliance (approved active-ingredient concentration, drug-facts label), facility registration with the FDA, and a responsible US agent designation. FDA may detain shipments from unregistered foreign manufacturers, so confirming registration status prior to shipment avoids costly delays. Consult a licensed customs broker or regulatory specialist for current requirements.