Anticavity Fluoride Rinse
Equaline 213.001/213AE rev 2 Anticavity Fluoride Rinse, Mint
Approved
Approval ID
e696038c-182e-4325-9b90-87fe498d9f67
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
United Natural Foods, Inc. dba UNFI
DUNS: 943556183
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 Code41163-213
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (19)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.2 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
Classification: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
EDETATE CALCIUM DISODIUM ANHYDROUSInactive
Code: 8U5D034955
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT