MedPath

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

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parodontax - FDA Drug Approval Details