Barbie Bubble Gum ANTICAVITY FLUORIDE

Product NDC
70108-082
Requested package NDC
70108-082-01
11-digit product format
701080082
Labeler code
70108
Product ID
70108-082_57d04905-1fd4-4fc9-a859-83d3215f1a32
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
Marketing end
2028-05-13
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
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

Active Ingredients#

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

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 34 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Whipped Mellow Mint Dream FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company7a72b687-475d-437a-9734-a29637e5516a2025-11-11WarningsExact identifier
application number: M021
Spry DentifriceTOOTHPASTEXlear Inc.43567bbc-b07e-b605-e063-6294a90aad782025-11-11WarningsExact identifier
application number: M021
Hello Naturally WhiteningSODIUM MONOFLUOROPHOSPHATECOLGATE PALMOLIVE COMPANY5ad241e1-6bfc-7863-6a7a-100753651f0a2025-11-11WarningsExact identifier
application number: M021
Hello Whipped Peppermint Stick FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyd6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f8132025-11-11WarningsExact identifier
application number: M021
Super MintMINT TOOTHPASTESuperMouth, LLC.d23e89f5-7b65-4ed9-803a-38233f30d8f22025-11-07WarningsExact identifier
application number: M021
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
application number: M021
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
application number: M021
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
application number: M021
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
application number: M021
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
application number: M021
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
application number: M021
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
application number: M021
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
application number: M021
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact 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 startMarketing endSampleExclude flagStatus
70108-082-01701080082011 TUBE in 1 BOX (70108-082-01) / 113 g in 1 TUBE1 tube2024-05-212028-05-13NoNoHistorical