MedPath

Parodontax

Drug Facts

Approved
Approval ID

32b632bf-058d-447b-a7fb-a9dd05c1e2b8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 8, 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.

Cetylpyridinium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0135-0652
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2025
FDA Product Classification

INGREDIENTS (11)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ZINC LACTATEInactive
Code: 2GXR25858Y
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CINNAMALDEHYDEInactive
Code: SR60A3XG0F
Classification: IACT
CETYLPYRIDINIUM CHLORIDEActive
Quantity: 70 mg in 1 mL
Code: D9OM4SK49P
Classification: ACTIB

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Parodontax - FDA Drug Approval Details