MedPath

Anticavity

Equate 971.001/1971AB Burn-Free Fluoride Anti-Cavity Mouthwash

Approved
Approval ID

4590ca97-130c-46b2-9ba0-38f4703ef30a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 28, 2025

Manufacturers
FDA

Walmart Inc.

DUNS: 051957769

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 Code49035-971
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification

INGREDIENTS (19)

SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
EUCALYPTOLInactive
Code: RV6J6604TK
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SPEARMINT OILInactive
Code: C3M81465G5
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.1 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM

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Anticavity - FDA Drug Approval Details