FDA.reportPublic FDA data

Crayola ANTICAVITY WATERMELON FLAVOR

Product NDC
70108-081
Requested package NDC
70108-081-01
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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#

Effective, Related label table
EffectiveRelated label
2025-03-21Crayola ANTICAVITY FLUORIDE TOOTHPASTE - WATERMELON FLAVOR
2025-03-21Crayola ANTICAVITY FLUORIDE TOOTHPASTE - WATERMELON FLAVOR
2025-01-30Crayola ANTICAVITY FLUORIDE TOOTHPASTE - WATERMELON FLAVOR
2025-01-30Crayola ANTICAVITY FLUORIDE TOOTHPASTE - WATERMELON FLAVOR

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 1 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-10-19WarningsExact identifier
application number: M021
Meridian Anticavity CinnamonSODIUM FLUORIDEBob Barker Company Inc.64d3cce9-1d99-4e6b-a7d8-cd8d2eb1d2e42026-09-23WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021
Kids Flouride RinseSODIUM FLUORIDEYour Military Exchanges5f6f4125-6264-4724-bb7e-a6e100939b412026-08-28Warnings, Adverse reactionsExact 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