Is Colgate Oral Pharmaceuticals, Inc. FDA approved?

Colgate Oral Pharmaceuticals, Inc. holds no registered establishment of its own; 20 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Colgate Oral Pharmaceuticals, Inc. make?

20 products are listed under Colgate Oral Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as gel, dentifrice; paste, dentifrice; rinse. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Colgate Oral Pharmaceuticals, Inc.

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

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Registered sites: 0
Active NDC listings: 20
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

20 active NDC listings: 14 human prescription drug, 5 human otc drug, 1 drug for further processing. By marketing category: UNAPPROVED DRUG OTHER 12, OTC MONOGRAPH DRUG 5, ANDA 2, DRUG FOR FURTHER PROCESSING 1.

Dosage form	NDCs
gel, dentifrice	7
paste, dentifrice	6
rinse	6
mouthwash	1

Route	NDCs
dental	16
buccal	3

Labeller name on the listing	NDCs
colgate oral pharmaceuticals, inc.	16
colgate oral pharmaceuticals inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE	rinse, dental	0126-0034OTC MONOGRAPH DRUG
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE	rinse, dental	0126-0032OTC MONOGRAPH DRUG
Gel-Kam Fruit and Berry	Stannous Fluoride	gel, dentifrice, dental	0126-0165OTC MONOGRAPH DRUG
Gel-Kam Mint	Stannous Fluoride	gel, dentifrice, dental	0126-0192OTC MONOGRAPH DRUG
-	Hydrogen Peroxide	rinse	0126-0084DRUG FOR FURTHER PROCESSING
Periogard Alcohol Free	Chlorhexidine Gluconate	rinse, buccal	0126-0272ANDA
Periogard Alcohol Free	Chlorhexidine Gluconate	rinse, buccal	0126-0282ANDA
Peroxyl Mouth Sore Mild Mint	Hydrogen Peroxide	rinse, buccal	0126-0083OTC MONOGRAPH DRUG
PreviDent 5000 Booster Plus Fruitastic	Sodium Fluoride	paste, dentifrice, dental	0126-0072UNAPPROVED DRUG OTHER
PreviDent 5000 Booster Plus Spearmint	Sodium Fluoride	paste, dentifrice, dental	0126-0074UNAPPROVED DRUG OTHER
PreviDent 5000 Dry Mouth	Sodium fluoride	gel, dentifrice, dental	0126-0016UNAPPROVED DRUG OTHER
PreviDent 5000 Enamel Protect	SODIUM FLUORIDE and POTASSIUM NITRATE	gel, dentifrice, dental	0126-0022UNAPPROVED DRUG OTHER
PreviDent 5000 Kids	Sodium Fluoride	paste, dentifrice, dental	0126-0311UNAPPROVED DRUG OTHER
PreviDent 5000 Plus Fruitastic	Sodium Fluoride	paste, dentifrice, dental	0126-0286UNAPPROVED DRUG OTHER
PreviDent 5000 Plus Spearmint	Sodium Fluoride	paste, dentifrice, dental	0126-0287UNAPPROVED DRUG OTHER
PreviDent 5000 Sensitive	Sodium fluoride and Potassium nitrate	gel, dentifrice, dental	0126-0070UNAPPROVED DRUG OTHER
PreviDent Alcohol Free	Sodium Fluoride	mouthwash, dental	0126-0033UNAPPROVED DRUG OTHER
PreviDent Fresh Mint	Sodium Fluoride	gel, dentifrice, dental	0126-0088UNAPPROVED DRUG OTHER
PreviDent OrthoDefense	SODIUM FLUORIDE	paste, dentifrice, dental	0126-0289UNAPPROVED DRUG OTHER
PreviDent Very Berry	Sodium Fluoride	gel, dentifrice, dental	0126-0288UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is Colgate Oral Pharmaceuticals, Inc. FDA approved?: Colgate Oral Pharmaceuticals, Inc. holds no registered establishment of its own; 20 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Colgate Oral Pharmaceuticals, Inc. make?: 20 products are listed under Colgate Oral Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as gel, dentifrice; paste, dentifrice; rinse. 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.