Flotrex

Product NDC
59088-017
11-digit product format
590880017
Labeler code
59088
Product ID
59088-017_39ed4312-2ed6-cb13-e063-6294a90aefc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Multivitamins, Sodium Fluoride 0.25 mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-03-19
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
6.75; 24; 10; 4.5; 300; 13.5; 1.05; 1.2; 36; .25; 1.05; 750 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flotrex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6.75 mg/1
VITAMIN A24 mg/1
ASCORBIC ACID10 ug/1
SODIUM ASCORBATE4.5 ug/1
CHOLECALCIFEROL300 ug/1
.ALPHA.-TOCOPHEROL ACETATE, DL-13.5 mg/1
THIAMINE MONONITRATE1.05 mg/1
RIBOFLAVIN1.2 mg/1
NIACINAMIDE36 mg/1
PYRIDOXINE HYDROCHLORIDE.25 mg/1
FOLIC ACID1.05 mg/1
CYANOCOBALAMIN750 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
81G40H8B0TInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
S033EH8359Internal UNII lookup
1C6V77QF41Internal UNII lookup
WR1WPI7EW8Internal UNII lookup
8K0I04919XInternal UNII lookup
TLM2976OFRInternal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
935E97BOY8Internal UNII lookup
P6YC3EG204Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30186998-2121-3ef2-e063-6394a90a513eAvailable on FDA.report

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-017-54Flotrex30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-017-54EA - Each59088-017904e83fe-0586-4d42-b837-b486bcf4596712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-017FLOTREX (MULTIVITAMINS, SODIUM FLUORIDE 0.25 MG) TABLET, CHEWABLE [PURETEK CORPORATION]2Current NDC, 1 package rows20250508_30186998-2121-3ef2-e063-6394a90a513e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FlotrexMULTIVITAMINS, SODIUM FLUORIDE 0.25 MGPureTek Corporation30186998-2121-3ef2-e063-6394a90a513e2025-07-14Warnings, Adverse reactionsExact identifier
ndc (product): 59088-017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59088-017-545908800175430 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) 2025-03-19NoNoCurrent