FDA.reportPublic FDA data

Crayola ANTICAVITY BUBBLE GUM FLAVOR

Manufacturer
Ashtel Studios, Inc.
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:38

Label at a glance#

ProductCrayola ANTICAVITY BUBBLE GUM FLAVOR
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

helps protect teeth and roots against cavities.

Dosage and administration

Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243%
(Fluoride ion content 1100 ppm)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect teeth and roots against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow.
  • Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD & C Red # 40

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

BrushBuddies®

Silly Scents

HELPS PREVENT CAVITIES

BUBBLE GUM FLAVOR

CAUTION:
AVOID EXCESSIVE INGESTION.
NOT FOR PETS.
NOT TESTED ON ANIMALS.

OFFICIAL LICENSED PRODUCT
DESIGNED IN U.S.A. •  MADE IN INDIA

QUALITY GUARANTEE

Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST

ABOUT US

Crayola A Hallmark Company

©2023 CRAYOLA, EASTON, PA 18044-0431.
Crayola™, Silly Scents™ and Chevron Design™ are trademarks of Crayola used under license.

make brushing fun!®

WWW.BRUSHBUDDIES.COM

• 1-909-434-0911 INTERNATIONAL

DISTRIBUTED BY ASHTEL STUDIOS INC., • ONTARIO, CALIFORNIA 91761
PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CrayolaBG-2CrayolaBG-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-076-012025-03-21C16284748780-12cef2736-abe2-d83d-e063-dadaa90ab31fCrayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR
70108-076-012025-01-30C16284748780-12cef2736-abe2-d83d-e063-dadaa90ab31fCrayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-076-01Crayola ANTICAVITY BUBBLE GUM FLAVOR113 g in 1 TUBEPASTE, DENTIFRICE1132
70108-076-01Crayola ANTICAVITY BUBBLE GUM FLAVOR1 in 1 BOXPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-076CRAYOLA ANTICAVITY BUBBLE GUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]2Current NDC, 2 package rows20250323_ec66246f-06e2-4da1-b9d5-ce2a7815ffd1.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-07670108-076-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
FD&C RED NO. 40WZB9127XOAIACT

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
Crayola ANTICAVITY BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios, Inc.ec66246f-06e2-4da1-b9d5-ce2a7815ffd12025-03-19WarningsExact identifier
ndc (package): 70108-076-01
ndc (product): 70108-076
ndc11 (package): 70108007601
spl id: 164bc453-ecba-490e-b10a-f9a4854735de
spl set id: ec66246f-06e2-4da1-b9d5-ce2a7815ffd1

Reported adverse events (FAERS/openFDA)#

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