Crayola ANTICAVITY WATERMELON FLAVOR

Product NDC
70108-081
11-digit product format
701080081
Labeler code
70108
Product ID
70108-081_a951bbf4-c554-457f-86da-6de0eb2ec4be
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
2023-09-06
Marketing end
2028-03-31
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70108-081-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70108-081-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70108-081-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70108-081-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70108-081-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70108-081-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70108-081-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Crayola ANTICAVITY WATERMELON FLAVOR

Active Ingredients#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-081-01Crayola ANTICAVITY WATERMELON FLAVOR1 in 1 BOXPASTE, DENTIFRICE12
70108-081-01Crayola ANTICAVITY WATERMELON FLAVOR113 g in 1 TUBEPASTE, DENTIFRICE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-081CRAYOLA ANTICAVITY WATERMELON FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]2Current NDC, 2 package rows20250323_720f6344-ac48-414c-a1c2-f56c3206343c.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 % ToothpastePSN720f6344-ac48-414c-a1c2-f56c3206343c2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD720f6344-ac48-414c-a1c2-f56c3206343c2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY720f6344-ac48-414c-a1c2-f56c3206343c2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY720f6344-ac48-414c-a1c2-f56c3206343c2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY720f6344-ac48-414c-a1c2-f56c3206343c2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY720f6344-ac48-414c-a1c2-f56c3206343c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70108-081-01701080081011 TUBE in 1 BOX (70108-081-01) / 113 g in 1 TUBE1 tube2023-09-062028-03-31NoNoHistorical