MedPath

Anticavity Fluoride

Childrens Anticavity Fluoride Rinse

Approved
Approval ID

63c4c0e9-84b1-4076-bdf4-7e9543b2cf46

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 29, 2025

Manufacturers
FDA

Family Dollar (FAMILY WELLNESS)

DUNS: 024472631

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 Code55319-807
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 29, 2025
FDA Product Classification

INGREDIENTS (14)

SODIUM FLUORIDEActive
Quantity: 0.05 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
DISODIUM PHOSPHATEInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM SACCHARINInactive
Code: SB8ZUX40TY
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
Classification: IACT
CALCIUM DISODIUM EDTAInactive
Code: 8U5D034955
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/29/2025

Package label

![Sodium fluoride 0.05% (0.02% w/vfluoride ion](/dailymed/image.cfm?name=childrens-anticavity-fluoride- rinse-1.jpg&id=900416)

FAMILY WELLNESS Children's Anticavity Fluoride Rinse Bubblegum Flavor

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/29/2025

Uses

aids in the prevention of dental cavities

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/29/2025

Inactive ingredients

water, sorbitol, propylene glycol, flavor, poloxamer 407, monosodium phosphate, benzyl alcohol, disodium phosphate, sodium benzoate, sodium saccharin, polysorbate 80, cetylpyridinium chloride, calcium disodium EDTA, D&C red no. 33

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/29/2025

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/29/2025

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/29/2025

Purpose

Anticavity rinse

WARNINGS SECTION

LOINC: 34071-1Updated: 9/29/2025

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/29/2025

Directions

Adults and children 6 years of age and older:
■ use once a day after brushing your teeth with a toothpaste
■ vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
■ do not swallow the rinse
■ do not eat or drink for 30 minutes after rinsing
■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
■ supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/29/2025

Other information

■ store at room temperature
■ do not use if safety seal is broken or missing

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Anticavity Fluoride - FDA Drug Approval Details