parodontax
Drug Facts
Approved
Approval ID
59bb84d6-6fd3-4586-bccf-7dc45cbbb39c
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0627
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
stannous fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (10)
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
SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT