FDA.reportPublic FDA data

Crayola ANTICAVITY STRAWBERRY FLAVOR

Product NDC
70108-080
11-digit product format
701080080
Labeler code
70108
Product ID
70108-080_ef2d9ffe-1657-474a-9b5d-fb79892bcb05
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
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Crayola ANTICAVITY STRAWBERRY FLAVOR
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-080-012025-03-21C16284748780-12cef2736-aade-d83d-e063-dadaa90ab31fCrayola ANTICAVITY FLUORIDE TOOTHPASTE - STRAWBERRY FLAVOR
70108-080-012025-01-30C16284748780-12cef2736-aade-d83d-e063-dadaa90ab31fCrayola ANTICAVITY FLUORIDE TOOTHPASTE - STRAWBERRY FLAVOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-080-01Crayola ANTICAVITY STRAWBERRY FLAVOR1 in 1 BOXPASTE, DENTIFRICE12
70108-080-01Crayola ANTICAVITY STRAWBERRY FLAVOR113 g in 1 TUBEPASTE, DENTIFRICE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-080CRAYOLA ANTICAVITY STRAWBERRY FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]2Current NDC, 2 package rows20250323_17bd65a8-0a33-4421-8b9a-a7f9b94fe987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN17bd65a8-0a33-4421-8b9a-a7f9b94fe9872
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD17bd65a8-0a33-4421-8b9a-a7f9b94fe9872
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY17bd65a8-0a33-4421-8b9a-a7f9b94fe9872
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY17bd65a8-0a33-4421-8b9a-a7f9b94fe9872
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY17bd65a8-0a33-4421-8b9a-a7f9b94fe9872
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY17bd65a8-0a33-4421-8b9a-a7f9b94fe9872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70108-080-01701080080011 TUBE in 1 BOX (70108-080-01) / 113 g in 1 TUBE1 tube2023-09-06NoNoCurrent