FDA.reportPublic FDA data

Firefly Anticavity Fluoride

Manufacturer
Ranir LLC
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:33

Label at a glance#

ProductFirefly Anticavity Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

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 o...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%

Purpose

OTC - PURPOSE SECTION

Anticavity rinse

Use

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 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

OTHER SAFETY INFORMATION

  • recommended storage temperature 59°-86°F(15°-30°C)
  • do not use if printed plastic neckband is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, menthol, poloxamer 407, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol

Questions?

OTC - QUESTIONS SECTION

Toll Free: 1-866-373-7374

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIREFLY™ ANTICAVITY Fluoride Rinse

PAW PATROL™

BUBBLE GUM

nickelodeon™

Helps PREVENT CAVITIES

ADA Accepted American Dental Association

Helps prevent cavities

Alcohol FREE

IMPORTANT: Read directions for proper use.

16 FL OZ (473 mL)

firefly-anticavity-fluoride-rinse-front
firefly-anticavity-fluoride-rinse-front
firefly-anticavity-fluoride-rinse-back
firefly-anticavity-fluoride-rinse-back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN2
240698sodium fluoride 0.5 MG/ML MouthwashSCD2
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66923-003-34Firefly Anticavity Fluoride237 mL in 1 BOTTLERINSE2372
66923-003-43Firefly Anticavity Fluoride473 mL in 1 BOTTLERINSE4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66923-003FIREFLY ANTICAVITY FLUORIDE (SODIUM FLUORIDE) RINSE [RANIR LLC]2Current NDC, Legacy NDC, 2 package rows20241122_e91ed8a1-0d45-402c-9c16-1ae72e695a37.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66923-00366923-003-43, 66923-003-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATESE337SVY37IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT

Source Document#

Source XML

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
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCe91ed8a1-0d45-402c-9c16-1ae72e695a372024-11-20WarningsExact identifier
ndc (package): 66923-003-43
ndc (package): 66923-003-34
ndc (product): 66923-003
ndc11 (package): 66923000343
ndc11 (package): 66923000334
spl id: bcec5748-5675-4b7b-b844-2ffbac08e719
spl set id: e91ed8a1-0d45-402c-9c16-1ae72e695a37

Reported adverse events (FAERS/openFDA)#

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