Multivitamin with Fluoride .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A and VITAMIN D 2500 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.05 mg; 1.2 mg; 13.5 mg; 1.05 mg; 300 ug; 4.5 ug Tablet, Chewable, 100-count
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
This is a chewable tablet containing a combination of vitamins and fluoride taken by mouth. The product includes B vitamins (thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin), vitamin C, vitamin A, vitamin D, vitamin E, folic acid, and sodium fluoride. These ingredients are typically found in multivitamin and mineral supplements intended to provide micronutrients and support dental health. This product is marketed without an approved FDA application.
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💊 What it looks like
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🧪 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 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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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 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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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 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII VCQ006KQ1E
Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
7 inactive ingredients listed in the exact product block matched to this NDC.
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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.Inactive ingredient FAQ
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💲 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. | |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-1136-01 You're viewing this | 100 TABLET, CHEWABLE in 1 BOTTLE (63629-1136-1) | 2018-07-20 | Active |
🧭 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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. M ultivitamin with Fluoride 0.5 mg Chewable Tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of age in areas where the drinking water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Multivitamin with Fluoride 0.5 mg Chewable 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. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements.
Children using Multivitamin with Fluoride 0 . 5 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.
Multivitamin with Fluoride Chewable 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.
⏱️ 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.
⚠️ 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 Allergic rash and other idiosyncrasies have been rarely reported.
🧬 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. Multivitamin with Fluoride 0 . 5 mg Chewable 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: Ca10(PO4)6(OH)2 + 2F- ------- Ca10(PO4)6F2 + 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 Multivitamin Chewable tablets containing 0.5 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M164” on one side. NDC 63629-1136-1: 100 (count) Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504