Flotrex Multivitamins, Sodium Fluoride 1 mg 1 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable, 30-count — NDC 59088-020-54 (Billing 59088-0020-54)
This is a package of 30 tablets of Flotrex Multivitamins, Sodium Fluoride 1 mg 1 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable from PureTek Corporation, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 59088-020-54 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 59088 labeler · 020 product · 54 package
- Package marketed since
- Jul 10, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 30 EA per package
- Barcode (UPC)
- 0359088020548
- FDA record last changed
- Oct 1, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 066017
- GCN: 28188
- GPI-14 (Medi-Span): 78441000000520
- HICL (First Databank): 036833
- AHFS class code: 88:28.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Flotrex is a chewable tablet containing a combination of vitamins and sodium fluoride taken by mouth. The product includes vitamins A, C, D, E, and B-complex vitamins (B1, B2, B3, B6, and B12) along with folic acid, which are typically found in multivitamin products and function as nutritional supplements. Sodium fluoride is commonly used in oral health products for dental care. This product is marketed as an unapproved drug and has not received FDA approval.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 59088-0020-54 You're viewing this Main listing | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2025-07-10 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Flotrex 1 mg/1; 750 ug/1; 24 mg/1; 36 mg/1; 10 ug/1; 6.75 mg/1; 1.05 mg/1; 1.2 mg/1; 13.5 mgthis 59088-0020-54 | PureTek | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII Z0H242BBR1
Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 2LRS185U6K
D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from PureTek Corporation labeler code 59088
- Prenatol-M Multivitamin 20 ug; 27 mg; 50 ug; 120 mg; 25 mg; 55 mg; 3.4 mg; 200 mg; 13.5 mg; 1500 Tablet NDC 59088-009-54
- Methylten Methyl Salicylate 10% 1 mg/g Cream NDC 59088-013-06
- Methyl Salicylate 25% Pain Relieving 250 mg/g Cream NDC 59088-014-06
- Flotrex Multivitamins, Sodium Fluoride 0.5 mg .5 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable NDC 59088-015-54
- Flotrex Multivitamins, Sodium Fluoride 0.25 mg .25 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable NDC 59088-017-54
- Multivitamin 750 ug; 24 mg; 36 mg; 10 ug; 10 mg; 1.05 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable NDC 59088-018-54
- Boostervite Multivitamin 18 mg; 50 mg; 2.5 mg; 300 ug; 10 mg; 10 mg; 100 mg; 1000 ug; 100 ug; 10 mg Tablet NDC 59088-022-54
- PNV Prenatol Multivitamin 3.4 mg; 20 mg; 120 mg; 1000 ug; 10 ug; 200 mg; 1500 ug; 3 mg; 25 mg; 2.6 mg Tablet NDC 59088-078-54
- Migranow sumatriptan succinate, camphor, menthol Kit NDC 59088-083-00
- Inflammacin diclofenac sodium, capsaicin Kit NDC 59088-093-00
- PureVit DualFe Plus Ferrous Fumarate, Polysaccharide Iron Complex .8 mg; 53 mg; 53 mg; 6 mg; 30 mg; 5 mg; 1 mg; 15 ug; 10 mg; 200 mg Capsule NDC 59088-112-66
- Diclofenac Potassium 25 mg Capsule, Liquid Filled NDC 59088-131-73
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.
⛔ Contraindications ▾
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets provide 1 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm.
Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets regularly should receive semiannual dental examinations.
The regular brushing of teeth and attention to good oral hygiene practices are also essential. Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.
⚠️ Warnings ▾
WARNING Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Caution: Do not eat or drink dairy products within one hour of fluoride administration. Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Folate: Allergic sensitization has been reported following both oral and parenteral administration of folate. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.
Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation: Ca 10 (PO 4 ) 6 (OH) 2 + 2F - ------- Ca 10 (PO 4 ) 6 F 2 + 2OH - (Hydroxyapatite) (Fluorapatite) Three stages of fluoride deposition in tooth enamel can be distinguished: 1.
Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2. After enamel has been laid down, fluoride deposition continues in the surface enamel.
Diffusion of fluoride from the surface inward is apparently restricted. 3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets are purple-colored, grape-flavored, unscored tablets available by prescription only in bottles of 30 tablets. (NDC: 59088-020-54). Dispense in a tight, light-resistant container with a child-resistant closure, as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to applicable state statutes. This is not an Orange Book product.
📦 Storage and Handling ▾
STORAGE Do not use if bottle seal is broken. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION: Active Ingredients: Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) ....................................................
10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ...........................................................................
1.2mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid).......................................
510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake).
Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.
⚠️ Precautions ▾
PRECAUTION The suggested dose of Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets: 1. Determine the fluoride content of the drinking water from all major sources.
2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3.
Periodically check to make sure that the child does not develop significant dental fluorosis. Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made.
Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
📄 Package Label / Principal Display Panel ▾
Flotrex™ Multivitamin Chewable plus 1 mg Fluoride Tablets Label
About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |