Multivitamin with Fluoride

Product NDC
59088-107
11-digit product format
590880107
Labeler code
59088
Product ID
59088-107_e920a341-5194-3453-e053-2a95a90a35d0
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; NIACINAMIDE; 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], 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 productproduct59088-107DDiscontinued by firm2026-09-14
excluded packagepackage59088-10759088-107-59DDiscontinued 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 · 26 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 packagepackage59088-107-59DDiscontinued 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 packagepackage59088-107-59DDiscontinued 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 packagepackage59088-107-59DDiscontinued 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 packagepackage59088-107-59DDiscontinued 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 packagepackage59088-107-59DDiscontinued 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 packagepackage59088-107-59DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59088-107-59IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59088-107-59IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59088-107-59IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59088-107-59IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59088-107-59IInactivated 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 packagepackage59088-107-59IInactivated 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 packagepackage59088-107-59IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-107-59EA - Each59088-1076d95f529-6f1c-4ebc-914f-23eb7e5bb34312012-07-24

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
59088-107-5959088010759100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-107-59) 2011-06-010000-00-00NoNoCurrent