Barbie Bubble Gum ANTICAVITY FLUORIDE

Product NDC
70108-082
11-digit product format
701080082
Labeler code
70108
Product ID
70108-082_38175bb9-cb2a-463a-9309-9ce668ff4557
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Ashtel Studios Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-21
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Barbie Bubble Gum ANTICAVITY FLUORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc5489e9-eeff-4db5-8793-21fb5bf4b2efAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-082-01Barbie Bubble Gum ANTICAVITY FLUORIDE1 in 1 BOXPASTE, DENTIFRICE11
70108-082-01Barbie Bubble Gum ANTICAVITY FLUORIDE113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-082BARBIE BUBBLE GUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS INC.]1Current NDC, 2 package rows20240524_dc5489e9-eeff-4db5-8793-21fb5bf4b2ef.zip

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 46 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum FlavorSODIUM FLUORIDEAshtel Studios Inc.bbf6cfe7-c5e5-4e63-ac7d-4535a0ca39732024-07-31WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios Inc.32780fe9-82bf-42f8-8218-bed5bc579c722024-07-30WarningsExact identifier
application number: M021
Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.7ba8cff2-92a4-4432-aaf3-50358d9483a22024-07-30WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios Inc.ed057c95-90cd-4edb-ac00-78db8f6a065b2024-07-29WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.f01c5eaf-7e81-4b30-bb6f-50566a7273642024-07-29WarningsExact identifier
application number: M021
Sodium MonofluorophosphateWHITE TOOTHPASTEDynarex Corporation1be422b9-6320-ed5c-e063-6294a90a7e422024-07-03WarningsExact identifier
application number: M021
Wpgcng Antiacvity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.5756206e-43cc-8cc7-e063-6394a90a29502024-07-03WarningsExact identifier
application number: M021
dentalux Kids ANTI-CAVITY FLUORIDE Bubble GumSODIUM FLUORIDELidl US, LLC0c77ba33-acb9-4c83-aa75-7d5c82f903eb2024-07-02WarningsExact identifier
application number: M021
dentalux ANTI-CAVITY FLUORIDE WHITENING MINTSODIUM FLUORIDELidl US, LLC37011052-16ef-4ae4-aade-a86f9fa9cdac2024-07-02WarningsExact identifier
application number: M021
dentalux ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATELidl US, LLCccf54743-81c2-43f8-9c5c-d4baa85fc18d2024-07-02WarningsExact identifier
application number: M021
SmileSenseSTANNOUS FLUORIDESGII, INC1c371393-da75-c9c8-e063-6294a90a58402024-07-01WarningsExact identifier
application number: M021
Sodium FluorideCLEAR MINT, GEL TOOTHPASTEDynarex Corporation1be193b6-4c07-4f0a-e063-6394a90a32c72024-06-27WarningsExact identifier
application number: M021
CREST CAVITY PROTECTION COOL MINTSODIUM FLUORIDEA-S Medication Solutionsdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d2024-06-12WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios Inc.a37e9d9c-dca9-4d58-a716-4514ebe8ec882024-06-11WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.0e6b01a4-1132-489f-936c-d3a54e9e21e02024-06-11WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios Inc.ffb8c43c-8f45-42ec-83eb-f0c83f7f99f82024-06-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening ToothpasteSODIUM FLUORIDETai Guk Pharm. Co., Ltd.1a26ad70-9773-dc4f-e063-6294a90ac3332024-05-31WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening ToothpasteSODIUM FLUORIDELG H&H Co.,Ltd.1a01481f-3e02-634e-e063-6394a90ac5fc2024-05-31WarningsExact identifier
application number: M021
Brush Buddies - Hot Wheels ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios Inc.86dd5e9c-71c3-46ce-ae4c-45d19468667d2024-05-29WarningsExact identifier
application number: M021
Dentalclean Doctor Duck Kids Flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda18806738-82fa-1a37-e063-6294a90a38882024-05-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNdc5489e9-eeff-4db5-8793-21fb5bf4b2ef1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDdc5489e9-eeff-4db5-8793-21fb5bf4b2ef1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYdc5489e9-eeff-4db5-8793-21fb5bf4b2ef1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYdc5489e9-eeff-4db5-8793-21fb5bf4b2ef1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYdc5489e9-eeff-4db5-8793-21fb5bf4b2ef1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYdc5489e9-eeff-4db5-8793-21fb5bf4b2ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70108-082-01701080082011 TUBE in 1 BOX (70108-082-01) / 113 g in 1 TUBE1 tube2024-05-21NoNoCurrent