Is Prime Tooth Care LLC FDA approved?

Prime Tooth Care LLC holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Prime Tooth Care LLC make?

8 products are listed under Prime Tooth Care LLC in the openFDA NDC Directory, most often as ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Prime Tooth Care LLC

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

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Registered sites: 0
Active NDC listings: 8
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human otc drug. By marketing category: OTC MONOGRAPH DRUG 8.

Dosage form	NDCs
ointment	8

Route	NDCs
dental	8

Labeller name on the listing	NDCs
prime tooth care llc	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Kids Prime Pediatric Dental Group Anticavity for Kids	SODIUM FLUORIDE	ointment, dental	87053-008OTC MONOGRAPH DRUG
Prime Tooth Care Blueberry	SODIUM FLUORIDE	ointment, dental	87053-001OTC MONOGRAPH DRUG
Prime Tooth Care Coconut Whip	SODIUM FLUORIDE	ointment, dental	87053-002OTC MONOGRAPH DRUG
Prime Tooth Care Hami Melon	SODIUM FLUORIDE	ointment, dental	87053-003OTC MONOGRAPH DRUG
Prime Tooth Care Juicy Peach	SODIUM FLUORIDE	ointment, dental	87053-004OTC MONOGRAPH DRUG
Prime Tooth Care Mango Smoothie	SODIUM FLUORIDE	ointment, dental	87053-005OTC MONOGRAPH DRUG
Prime Tooth Care Strawberries	SODIUM FLUORIDE	ointment, dental	87053-006OTC MONOGRAPH DRUG
Prime Tooth Care Summer Watermelon	SODIUM FLUORIDE	ointment, dental	87053-007OTC MONOGRAPH DRUG

Compare

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Enquiry

Common questions

Is Prime Tooth Care LLC FDA approved?: Prime Tooth Care LLC holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Prime Tooth Care LLC make?: 8 products are listed under Prime Tooth Care LLC in the openFDA NDC Directory, most often as ointment. 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.