Sparkle Fresh Anticavity

Product NDC
53329-082
Requested package NDC
53329-082-92
11-digit product format
533290082
Labeler code
53329
Product ID
53329-082_cdc606a6-daff-5226-e053-2995a90a8810
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Medline Industries, LP
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-04-01
Marketing end
2022-08-31
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage53329-08253329-082-92DDiscontinued 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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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 INGREDIENT8ZYQ1474W7SPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9SPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSPARKLE FRESH ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-082-925332900829217 g in 1 TUBE (53329-082-92) 17 g2008-04-010000-00-00NoNoCurrent