FDA.reportPublic FDA data

Childrens Anticavity Fluoride Rinse

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2026-04-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:52:30

Label at a glance#

ProductAnticavity Fluoride
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

aids in the prevention of dental cavities

Dosage and administration

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 with...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity rinse

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*

Children's 

ANTICAVITY

FLUORIDE RINSE

6+ YEARS

Sodium Fluoride 0.05%

  • Help prevent cavities
  • Alcohol Free

IMPORTANT: Read directions for proper use.

BUBBLEGUM FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Children's Anticavity Fluoride Rinse BubbleGum Flavor
FAMILY WELLNESS Children's Anticavity Fluoride Rinse BubbleGum Flavor

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251773815GTIN-13: 0032251773815
EAN-13: 0032251773815
GTIN-12: 032251773815
UPC-A: 032251773815
GTIN storage (14 digits): 00032251773815		childrens-anticavity-fluoride-rinse-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-807-18Anticavity Fluoride500 mL in 1 BOTTLE, PLASTICMOUTHWASH5004

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-80755319-807-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 407TUF2IVW3M2IACT
BENZYL ALCOHOLLKG8494WBHIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM SACCHARINSB8ZUX40TYIACT
POLYSORBATE 806OZP39ZG8HIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
CALCIUM DISODIUM EDTA8U5D034955IACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-09monthly-update2026-06-03 17:38:54
22025-09-29full-release2026-06-01 01:15:20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity FluorideSODIUM FLUORIDEFamily Dollar (FAMILY WELLNESS)63c4c0e9-84b1-4076-bdf4-7e9543b2cf462026-04-01WarningsExact identifier
ndc (package): 55319-807-18
ndc (product): 55319-807
ndc11 (package): 55319080718
spl id: 55150efe-465e-4f46-ab4e-c75b2b085a46
spl set id: 63c4c0e9-84b1-4076-bdf4-7e9543b2cf46

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.