Made by Dentist For Kids Chew Toy Bubblegum

Manufacturer
Fulijaya Manufacturing Sdn. Bhd
Effective date
2025-02-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:43

Label at a glance#

ProductMade by Dentist For Kids Chew Toy Bubblegum
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably 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), and only use a pea size amount. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentis...

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity 

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of cavitites.

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 accidently 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, preferably 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), and only use a pea size amount.
  • 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

Glycerin, Water (Aqua), Hydrated Silica, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Flavor, Sodium Saccharin, Potassium Sorbate

Questions or comments?

OTC - QUESTIONS SECTION

+ 1 (646) 980-6461

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label.jpgOuter Label.jpgInner Label.jpgInner Label.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 1Label 1

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62776-006-01Made by Dentist For Kids Chew Toy Bubblegum1 in 1 CARTONPASTE12
62776-006-01Made by Dentist For Kids Chew Toy Bubblegum120 g in 1 TUBEPASTE1202
62776-006-02Made by Dentist For Kids Chew Toy Bubblegum20 g in 1 TUBEPASTE202
62776-006-02Made by Dentist For Kids Chew Toy Bubblegum1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62776-006MADE BY DENTIST FOR KIDS CHEW TOY BUBBLEGUM (SODIUM FLUORIDE) PASTE [FULIJAYA MANUFACTURING SDN. BHD]24 package rows20250223_9bf15cd9-c473-43a5-bbff-507f66a17a56.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62776-00662776-006-01, 62776-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
2eaa999c-6ff2-9025-e063-6394a90a7dc59bf15cd9-c473-43a5-bbff-507f66a17a562025-02-21WarningsExact identifier
spl id: 2eaa999c-6ff2-9025-e063-6394a90a7dc5
spl set id: 9bf15cd9-c473-43a5-bbff-507f66a17a56

Reported adverse events (FAERS/openFDA)#

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