FDA.reportPublic FDA data

Fluoride

Product NDC
59088-105
Requested package NDC
59088-105-73
11-digit product format
590880105
Labeler code
59088
Product ID
59088-105_90a18708-82e0-4dc8-adee-e908f3d356c7
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59088-10559088-105-73DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59088-10559088-105-73UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59088-10559088-105-73UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
59088-105-64EA - Each59088-105e992b4e7-6e5c-4519-8394-fc99fabba01d12012-07-24
59088-105-73EA - Each59088-105f6334df2-6487-41cf-8b4a-ba85792b6b2912012-07-24

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
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KFLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUORIDE (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
59088-105FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]3Legacy NDC20250131_75d61626-753b-435a-b6d6-503da08e3733.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59088-105-7359088010573120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-105-73) 2011-06-010000-00-00NoNoCurrent