Multivitamin with Fluoride

Product NDC
59088-109
11-digit product format
590880109
Labeler code
59088
Product ID
59088-109_e4aac9f1-db2e-72e9-e053-2a95a90a3b54
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
.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A
Active strength
10 mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct59088-109DDiscontinued by firm2026-09-14
excluded packagepackage59088-10959088-109-59DDiscontinued by firm2026-09-14

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59088-109-59DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59088-109-59DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59088-109-59DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59088-109-59DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59088-109-59DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59088-109-59DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59088-109-59IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59088-109-59IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59088-109-59IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-109-59EA - Each59088-109e4f8f5c0-4cac-42a7-ad34-af68e42f03c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW8MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD4MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFRMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
SODIUM ASCORBATEACTIVE INGREDIENTS033EH8359MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919XMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
VITAMIN AACTIVE INGREDIENT81G40H8B0TMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
ALPHA-TOCOPHEROLACTIVE MOIETYH4N855PNZ1MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FOLIC ACIDACTIVE MOIETY935E97BOY8MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
NIACINAMIDEACTIVE MOIETY25X51I8RD4MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
RIBOFLAVINACTIVE MOIETYTLM2976OFRMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
THIAMINEACTIVE MOIETYX66NSO3N35MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
VITAMIN AACTIVE MOIETY81G40H8B0TMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554MULTIVITAMIN WITH FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [PURETEK CORPORATION]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59088-109-5959088010959100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-109-59) 2011-06-010000-00-00NoNoCurrent