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 00:38:27

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

purified water, sorbitol, propylene glycol, PEG-40 hydrogenated castor oil, sodium benzoate, poloxamer 407, xylitol, flavor, sucralose, citric acid, cetylpyridinium chloride, disodium EDTA, sodium phosphate, disodium phosphate, D&C red #33, FD&C blue #1

Questions?

OTC - QUESTIONS SECTION

Toll Free: 1-866-373-7374

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIREFLY® ANTICAVITY Fluoride Rinse

Disney PIXAR

TOY STORY

BUBBLE BERRY

Helps PREVENT CAVITIES

ADA Accepted American Dental Association®

Helps prevent cavities

Alcohol FREE

IMPORTANT: Read directions for proper use.

16 FL OZ (473 mL)

anticavity-toy-story
anticavity-toy-story

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66923-111-43Firefly Anticavity Fluoride473 mL in 1 BOTTLERINSE4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66923-111FIREFLY ANTICAVITY FLUORIDE (SODIUM FLUORIDE) RINSE [RANIR LLC]2Current NDC, Legacy NDC, 1 package rows20241122_abdc7f79-5f87-4307-8ddd-e6281ac67a04.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66923-11166923-111-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM BENZOATEOJ245FE5EUIACT
POLOXAMER 407TUF2IVW3M2IACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
ndc (package): 66923-111-43
ndc (product): 66923-111
ndc11 (package): 66923011143
spl id: 0289fb4d-fd6d-40c8-9365-90d34b7dfd2a
spl set id: abdc7f79-5f87-4307-8ddd-e6281ac67a04

Reported adverse events (FAERS/openFDA)#

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