MedPath

PreviDent

Colgate

Approved
Approval ID

d93ee76f-454b-40bf-9357-39a2ae3b6ccb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2022

Manufacturers
FDA

Colgate Oral Pharmaceuticals, Inc.

DUNS: 968801118

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0126-0016
Product Classification
G
Generic Name
Sodium fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateNovember 28, 2022
FDA Product Classification

INGREDIENTS (1)

SODIUM FLUORIDEActive
Quantity: 6.1 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM

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PreviDent - FDA Drug Approval Details