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
NDC Product Code11344-900
Application Number505G(a)(3)
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NameCetylpyridinium Chloride
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