PreviDent Fresh Mint
Colgate PreviDent Gel
Approved
Approval ID
2ecc57ec-cd25-4911-9247-6375569b8abe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2023
Manufacturers
FDA
Colgate Oral Pharmaceuticals, Inc.
DUNS: 968801118
Products 2
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 Code0126-0288
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 17, 2023
FDA Product Classification
INGREDIENTS (9)
Sodium FluorideActive
Quantity: 5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
SorbitolInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0126-0088
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateMarch 17, 2023
FDA Product Classification
INGREDIENTS (9)
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Sodium FluorideActive
Quantity: 5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT