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
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a chewable tablet containing a combination of vitamins and fluoride taken by mouth. It includes vitamin A and vitamin D for bone and immune support, vitamin C for collagen formation and antioxidant functions, and B vitamins (thiamine, riboflavin, niacin, vitamin B6, and vitamin B12) that typically help the body convert food into energy and maintain nerve function. The product also contains sodium fluoride, which is commonly used in dental products to support tooth strength. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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?
🔁 Therapeutic equivalents
Where does this data come from?
⏳ 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-1134-01 You're viewing this | 100 TABLET, CHEWABLE in 1 BOTTLE (63629-1134-1) | 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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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. |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 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. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Multivitamin with Fluoride 0.25 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 . 25 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 . 25 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 0.25 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M163” on one side. NDC 63629-1134-1 (100 count) Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504