FDA.reportPublic FDA data

Fluoride

Product NDC
59088-106
11-digit product format
590880106
Labeler code
59088
Product ID
59088-106_295f929c-f202-4d4a-987d-203ef5260592
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59088-106DDiscontinued by firm2026-10-12
excluded packagepackage59088-10659088-106-73DDiscontinued by firm2026-10-12

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59088-106-73ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59088-106-730efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-106-64EA - Each59088-1065cba06b8-7937-4177-9819-f81059ac6e4112012-07-24
59088-106-73EA - Each59088-1068c0816f4-6c74-47a9-865b-8172c171b4c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OFLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-106FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]4Legacy NDC20250131_58b3e7ff-c032-4e42-823a-8ed7b93d606f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59088-106-7359088010673120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-106-73) 2011-06-010000-00-00NoNoCurrent