Flotrex
- Product NDC
- 59088-020
- 11-digit product format
- 590880020
- Labeler code
- 59088
- Product ID
- 59088-020_399c637c-0e25-9b11-e063-6294a90a4c28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Multivitamins, Sodium Fluoride 1 mg
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- PureTek Corporation
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2025-07-10
- 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; 1; 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
openFDA Listing Details
- Product ID
- 59088-020_399c637c-0e25-9b11-e063-6294a90a4c28
- SPL ID
- 399c637c-0e25-9b11-e063-6294a90a4c28
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Flotrex
- Generic name
- Multivitamins, Sodium Fluoride 1 mg
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Marketing start
- 2025-07-10
- Marketing category
- UNAPPROVED DRUG OTHER
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient]; 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 D [CS]; Vitamin D [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | 6.75 mg/1 |
| ASCORBIC ACID | 24 mg/1 |
| CHOLECALCIFEROL | 10 ug/1 |
| CYANOCOBALAMIN | 4.5 ug/1 |
| FOLIC ACID | 300 ug/1 |
| NIACINAMIDE | 13.5 mg/1 |
| PYRIDOXINE HYDROCHLORIDE | 1.05 mg/1 |
| RIBOFLAVIN | 1.2 mg/1 |
| SODIUM ASCORBATE | 36 mg/1 |
| SODIUM FLUORIDE | 1 mg/1 |
| THIAMINE MONONITRATE | 1.05 mg/1 |
| VITAMIN A | 750 ug/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | WR1WPI7EW8, PQ6CK8PD0R, 1C6V77QF41, P6YC3EG204, 935E97BOY8, 25X51I8RD4, 68Y4CF58BV, TLM2976OFR, S033EH8359, 8ZYQ1474W7, 8K0I04919X, 81G40H8B0T |
| Spl Set Id | 399c637c-0e25-9b11-e063-6294a90a4c28 |
| Manufacturer Name | PureTek Corporation |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 59088-020-54 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) | 2025-07-10 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WR1WPI7EW8 | .ALPHA.-TOCOPHEROL ACETATE, DL- | 52225-20-4 | .ALPHA.-TOCOPHEROL ACETATE, DL- |
| PQ6CK8PD0R | ASCORBIC ACID | 50-81-7 | ASCORBIC ACID |
| 1C6V77QF41 | CHOLECALCIFEROL | 67-97-0 | CHOLECALCIFEROL |
| P6YC3EG204 | CYANOCOBALAMIN | 68-19-9 | CYANOCOBALAMIN |
| 935E97BOY8 | FOLIC ACID | 59-30-3 | FOLIC ACID |
| 25X51I8RD4 | NIACINAMIDE | 98-92-0 | NIACINAMIDE |
| 68Y4CF58BV | PYRIDOXINE HYDROCHLORIDE | 58-56-0 | PYRIDOXINE HYDROCHLORIDE |
| TLM2976OFR | RIBOFLAVIN | 83-88-5 | RIBOFLAVIN |
| S033EH8359 | SODIUM ASCORBATE | 134-03-2 | SODIUM ASCORBATE |
| 8ZYQ1474W7 | SODIUM FLUORIDE | 7681-49-4 | SODIUM FLUORIDE |
| 8K0I04919X | THIAMINE MONONITRATE | 532-43-4 | THIAMINE MONONITRATE |
| 81G40H8B0T | VITAMIN A | 11103-57-4 | VITAMIN A |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59088-020-54 | 59088002054 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) | 2025-07-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Flotrex | PureTek Corporation | 2025-07-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |