FDA.reportPublic FDA data

Barbie

Manufacturer
Ashtel Studios, Inc.
Effective date
2018-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:30

Label at a glance#

ProductBarbie
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Indications and uses

Helps protect teeth and roots against cavities.

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day. Use as directed by a dentist. Do not swallow. To minimize swallowing, use a pea-sized amount in children under 6 years of age. Supervise children's brushing until good brushing habit are established. Children under 2 years of age: Ask a dentist.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Uses

INDICATIONS & USAGE SECTION

Helps protect teeth and roots against cavities.

Warning

WARNINGS SECTION

If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • Brush teeth thoroughly after meals or at least twice a day. Use as directed by a dentist.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6 years of age.
  • Supervise children's brushing until good brushing habit are established.
  • Children under 2 years of age: Ask a dentist.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature.

SPL UNCLASSIFIED SECTION

BUBBLE GUM FLAVOR

HELPS PREVENT CAVITIES!

ANTICAVITY FLUORIDE TOOTHPASTE

Alcohol & Sugar Free

QUESTIONS OR COMMENTS?

1-877-274-8358 (U.S.A.)

1-909-434-0911 (INTERNATIONAL)

ONTARIO, CA 91761

DESIGNED IN U.S.A.

MADE IN CHINA

DISTRIBUTED BY ASHTEL STUDIOS INC.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BarbienwBarbienw

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-016-012020-01-31C16284748780-19d75b9d0-0aa5-f424-e053-dadaa90a57ceBarbie Anticavity Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-016-01Barbie119 g in 1 TUBEPASTE, DENTIFRICE1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-016BARBIE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]1Legacy NDC, 1 package rows20180803_210676d8-bbb9-4bd0-8fa3-9d12dbf21649.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-01670108-016-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
XYLITOLVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ROSE BENGAL SODIUM956575SN5LIACT

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
5b0cc7f5-47ab-46cb-9207-c29f98d5de54210676d8-bbb9-4bd0-8fa3-9d12dbf216492018-07-27WarningsExact identifier
spl id: 5b0cc7f5-47ab-46cb-9207-c29f98d5de54
spl set id: 210676d8-bbb9-4bd0-8fa3-9d12dbf21649

Reported adverse events (FAERS/openFDA)#

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