Is Ultradent Products, Inc. FDA approved?

Ultradent Products, Inc. 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 Ultradent Products, Inc. make?

8 products are listed under Ultradent Products, Inc. in the openFDA NDC Directory, most often as gel, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Ultradent Products, Inc.

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

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Registered sites: 0
Active NDC listings: 8
Labeller names: 2
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
gel, dentifrice	8

Route	NDCs
dental	8

Labeller name on the listing	NDCs
ultradent products, inc.	7
ultradent products, inc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Opal by Opalescence Complete	Opal by Opalescence Complete	gel, dentifrice, dental	51206-313OTC MONOGRAPH DRUG
Opal by Opalescence Original	Sodium Fluoride	gel, dentifrice, dental	51206-312OTC MONOGRAPH DRUG
Opal by Opalescence Sensitivity	Potassium Nitrate and Sodium Fluoride	gel, dentifrice, dental	51206-311OTC MONOGRAPH DRUG
Opalescence Sensitivity Relief Whitening	Potassium Nitrate and Sodium Fluoride	gel, dentifrice, dental	51206-308OTC MONOGRAPH DRUG
Opalescence Whitening	Sodium Fluoride	gel, dentifrice, dental	51206-302OTC MONOGRAPH DRUG
Opalescence Whitening Cool Mint	Sodium Fluoride	gel, dentifrice, dental	51206-314OTC MONOGRAPH DRUG
Opalescence Whitening Original Cool Mint Cool Mint	Sodium Fluoride	gel, dentifrice, dental	51206-450OTC MONOGRAPH DRUG
Opalescence Whitening Sensitivity Relief	Potassium Nitrate and Sodium Fluoride	gel, dentifrice, dental	51206-315OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Ultradent Products, Inc. FDA approved?: Ultradent Products, Inc. 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 Ultradent Products, Inc. make?: 8 products are listed under Ultradent Products, Inc. in the openFDA NDC Directory, most often as gel, dentifrice. 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.