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SITCSection 5
U.S. imports of oral and dental hygiene preparations, including denture fixatives (SITC 55340) totaled $54.8M in April 2026, traded with 40 countries.
Importers of Oral and Dental Hygiene Preparations, Including Denture Fixatives paid $3.6M in duties in April 2026 — an effective duty rate of 12% on $30.0M in dutiable value, based on actual customs collections rather than the published tariff schedule. Oral and Dental Hygiene Preparations, Including Denture Fixatives imports of $54.8M in April 2026 ran 16% above the year-to-date monthly average of $47.1M.
Last updated: April 2026 dataToothpastes, mouthwashes, dental floss, and denture adhesives occupy a regulatory intersection between cosmetics and OTC drugs: fluoride toothpastes are classified as OTC drugs under the FDA's fluoride monograph, while non-fluoride toothpastes and most mouthwashes are cosmetics. Denture fixative pastes and powders are cosmetics unless they bear therapeutic claims. Importers must resolve this distinction before entry, as OTC drug products require drug-facts labeling, approved active ingredients, and compliance with current good manufacturing practices.
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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.
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Monthly import values over time