CPH Anti-bacterial Breath Mist
Drug Facts
Approved
Approval ID
c421c473-d1b7-4ba5-a562-1c29f64e9b43
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
OraLabs
DUNS: 801824756
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 Code63645-179
Application Number356
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Quantity: 11.18 mL in 13 mL
Code: 059QF0KO0R
Classification: IACT
HYDROGENATED CASTOR OILInactive
Quantity: 1.3 mL in 13 mL
Code: ZF94AP8MEY
Classification: IACT
MENTHOL, (+)-Inactive
Quantity: 0.0065 mL in 13 mL
Code: C6B1OE8P3W
Classification: IACT
SUCRALOSEInactive
Quantity: 0.039 mL in 13 mL
Code: 96K6UQ3ZD4
Classification: IACT
CETYLPYRIDINIUM CHLORIDEActive
Quantity: 1.11 g in 13 mL
Code: D9OM4SK49P
Classification: ACTIB