Crayola

Product NDC
52376-044
Requested package NDC
52376-044-10
11-digit product format
523760044
Labeler code
52376
Product ID
52376-044_fea01824-3e85-4cb6-9b5e-ee94ba1536ff
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Sunstar Americas, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-11-30
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52376-04452376-044-10DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECRAYOLA SQUEEZE-A-COLOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52376-044-1052376004410119 g in 1 TUBE (52376-044-10) 119 g2015-11-300000-00-00NoNoCurrent