FDA.reportPublic FDA data

Firefly Bubble Gum natural fluoride

Manufacturer
Ranir LLC
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:39:12

Label at a glance#

ProductFirefly Bubble Gum natural fluoride
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

• adults and children 2 years of age and older: brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) • supervise children as necessary until capable of using without supervision • children under 2 years of age: consult a dentist or doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor
  • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, zylitol, glycerin, flavor, xanthan gum, lauryl glucoside, cocamidopropyl betaine, stevia rebaudiana extract

Questions?

OTC - QUESTIONS SECTION

Toll Free: 1-866-373-7374

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIREFLY®

BUBBLE GUM natural fluoride toothpaste

98% natural origin

SONIC™ THE HEDGEHOG

FIGHTS CAVITIES

NO artificial flavors

NO artificial colors

ADA Accepted American Dental Association®

NET WT 4.2 oz (119 g)

firefly-bubblegum-nmq-j
firefly-bubblegum-nmq-j

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66923-119-00Firefly Bubble Gum natural fluoride119 g in 1 TUBEPASTE, DENTIFRICE1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66923-119FIREFLY BUBBLE GUM NATURAL FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [RANIR LLC]1Current NDC, 1 package rows20241127_2a882210-49e6-4b9c-a2c6-eaa37b6514c3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66923-11966923-119-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT

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 Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
ndc (package): 66923-119-00
ndc (product): 66923-119
ndc11 (package): 66923011900
spl id: 2a882210-49e6-4b9c-a2c6-eaa37b6514c3
spl set id: 2a882210-49e6-4b9c-a2c6-eaa37b6514c3

Reported adverse events (FAERS/openFDA)#

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