FDA.reportPublic FDA data

Crayola ANTICAVITY BUBBLE GUM FLAVOR

Product NDC
70108-076
Requested package NDC
70108-076-01
11-digit product format
701080076
Labeler code
70108
Product ID
70108-076_10fef64a-932f-4ef2-8eca-563a4f2d2b3f
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 BUBBLE GUM 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 - BUBBLE GUM FLAVOR
2025-03-21Crayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR
2025-01-30Crayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR
2025-01-30Crayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-076-01Crayola ANTICAVITY BUBBLE GUM FLAVOR113 g in 1 TUBEPASTE, DENTIFRICE1132
70108-076-01Crayola ANTICAVITY BUBBLE GUM FLAVOR1 in 1 BOXPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-076CRAYOLA ANTICAVITY BUBBLE GUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]2Current NDC, 2 package rows20250323_ec66246f-06e2-4da1-b9d5-ce2a7815ffd1.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 37 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNec66246f-06e2-4da1-b9d5-ce2a7815ffd12
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDec66246f-06e2-4da1-b9d5-ce2a7815ffd12
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYec66246f-06e2-4da1-b9d5-ce2a7815ffd12
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYec66246f-06e2-4da1-b9d5-ce2a7815ffd12
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYec66246f-06e2-4da1-b9d5-ce2a7815ffd12
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYec66246f-06e2-4da1-b9d5-ce2a7815ffd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70108-076-01701080076011 TUBE in 1 BOX (70108-076-01) / 113 g in 1 TUBE1 tube2023-09-062028-03-31NoNoHistorical