Oral Antivavity
Harris Teeter 576.001/576AC-AD Alcohol Free Fluoride Refreshing Mint Mouthwash
Approved
Approval ID
571f7628-fd59-462f-96dd-67aeaa98cff1
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 1, 2025
Manufacturers
FDA
HARRIS TEETER, LLC
DUNS: 047279351
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72036-576
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium fluoride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (13)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.1 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT