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parodontax

Drug Facts

Approved
Approval ID

817e804c-e55e-4d77-9ab9-ff54ae794725

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 22, 2025

Manufacturers
FDA

Haleon US Holdings LLC

DUNS: 079944263

Products 1

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

stannous fluoride

PRODUCT DETAILS

NDC Product Code0135-0638
Application NumberM022
Marketing CategoryC200263
Route of AdministrationDENTAL
Effective DateApril 22, 2025
Generic Namestannous fluoride

INGREDIENTS (10)

SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 1.10 mg in 1 g
Code: 3FTR44B32Q
Classification: ACTIM
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT

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parodontax - FDA Drug Approval Details