Antigingivitis/Antiplaque
Swan D00.001/D00AA Alcohol-Free Gum Defense Mouthwash
Approved
Approval ID
a66d8d21-1ebf-45e6-97bd-dbe17ee67162
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Consumer Product Partners, LLC
DUNS: 119091520
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 Code11344-900
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (11)
CETYLPYRIDINIUM CHLORIDEActive
Quantity: 0.7 mg in 1 mL
Code: D9OM4SK49P
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ZINC LACTATEInactive
Code: 2GXR25858Y
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
CINNAMALDEHYDEInactive
Code: SR60A3XG0F
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT