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Anticavity Fluoride Rinse

Harris Teeter 213.002/213AE Rev 2 Anticavity Fluoride Rinse, Mint

Approved
Approval ID

f759e9e4-6de2-4b80-903b-e67c06e36295

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

NDC Product Code72036-213
Application NumberM021
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 1, 2025
Generic NameSodium Fluoride

INGREDIENTS (19)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
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 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
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.2 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM

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Anticavity Fluoride Rinse - FDA Drug Approval Details