Is DMG AMERICA, LLC FDA approved?

DMG AMERICA, LLC holds no registered establishment of its own; 15 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does DMG AMERICA, LLC make?

15 products are listed under DMG AMERICA, LLC in the openFDA NDC Directory, most often as gel; aerosol, foam. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

DMG AMERICA, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 15
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

15 active NDC listings: 10 human prescription drug, 5 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 10, OTC MONOGRAPH DRUG 5.

Dosage form	NDCs
gel	10
aerosol, foam	5

Route	NDCs
dental	15

Labeller name on the listing	NDCs
dmg america, llc	15

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT	SODIUM FLUORIDE	aerosol, foam, dental	25047-765UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY	SODIUM FLUORIDE	gel, dental	25047-774UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE	SODIUM FLUORIDE	gel, dental	25047-772UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY	SODIUM FLUORIDE	gel, dental	25047-773UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE FOAM BLUE RASPBERRY	SODIUM FLUORIDE	aerosol, foam, dental	25047-764UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE FOAM CHERRY CHEESECAKE	SODIUM FLUORIDE	aerosol, foam, dental	25047-762UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE FOAM COTTON CANDY	SODIUM FLUORIDE	aerosol, foam, dental	25047-763UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT	SODIUM FLUORIDE	aerosol, foam, dental	25047-761UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE PINA COLADA	SODIUM FLUORIDE	gel, dental	25047-775UNAPPROVED DRUG OTHER
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT	SODIUM FLUORIDE	gel, dental	25047-771UNAPPROVED DRUG OTHER
KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY	BENZOCAINE	gel, dental	25047-754OTC MONOGRAPH DRUG
KOLORZ TOPICAL ANESTHETIC CHERRY BURST	BENZOCAINE	gel, dental	25047-752OTC MONOGRAPH DRUG
KOLORZ TOPICAL ANESTHETIC COTTON CANDY	BENZOCAINE	gel, dental	25047-753OTC MONOGRAPH DRUG
KOLORZ TOPICAL ANESTHETIC PINA COLADA	BENZOCAINE	gel, dental	25047-755OTC MONOGRAPH DRUG
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	Benzocaine	gel, dental	25047-751OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is DMG AMERICA, LLC FDA approved?: DMG AMERICA, LLC holds no registered establishment of its own; 15 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does DMG AMERICA, LLC make?: 15 products are listed under DMG AMERICA, LLC in the openFDA NDC Directory, most often as gel; aerosol, foam. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.