Multivitamin With Fluoride Tablet, Chewable
NDC 58657-165

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58657-165?
  5. Multivitamin With Fluoride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Multivitamin With Fluoride (.alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d) is a UNAPPROVED DRUG OTHER-approved product labeled by Method Pharmaceuticals, Llc. This medication is a combination product of vitamins and fluoride. It is supplied as a yellow tablet, chewable for oral administration. This product entry covers the primary NDC 58657-165 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58657-165
Proprietary Name:
Multivitamin With Fluoride
Non-Proprietary Name: [1]
.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D
Substance Name: [2]
.alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Cyanocobalamin; Folic Acid; Niacin; Pyridoxine; Riboflavin; Sodium Fluoride; Thiamine Mononitrate; Vitamin A; Vitamin D
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Method Pharmaceuticals, Llc
Labeler Code:
58657
Product Label ID:
71698332-4ab1-4cbb-a98d-1694b715924b
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
07-20-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOWISH/CREAM)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
M165
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 58657-165?

The NDC code 58657-165 is assigned by the FDA to the product Multivitamin With Fluoride. It is commonly known by its generic name, .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d. This pharmaceutical product is labeled by Method Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a tablet, chewable administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 58657-165-01, 58657-165-90. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is a combination product of vitamins and fluoride. It is used in children to treat or prevent deficiency due to poor diet or low levels of fluoride in drinking water and other sources. Vitamins are important building blocks of the body and help keep you in good health. Fluoride is used to prevent dental cavities.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU]/1
  • ASCORBIC ACID 60 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • CYANOCOBALAMIN 4.5 ug/1
  • FOLIC ACID 300 ug/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • NIACIN 13.5 mg/1 - A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.
  • PYRIDOXINE 1.05 mg/1 - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
  • RIBOFLAVIN 1.2 mg/1 - Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as FLAVIN MONONUCLEOTIDE and FLAVIN-ADENINE DINUCLEOTIDE.
  • SODIUM FLUORIDE 1 mg/1 - A source of inorganic fluoride which is used topically to prevent dental caries.
  • THIAMINE MONONITRATE 1.05 mg/1 - 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.
  • VITAMIN A 2500 [iU]/1 - Retinol and derivatives of retinol that play an essential role in metabolic functioning of the retina, the growth of and differentiation of epithelial tissue, the growth of bone, reproduction, and the immune response. Dietary vitamin A is derived from a variety of CAROTENOIDS found in plants. It is enriched in the liver, egg yolks, and the fat component of dairy products.
  • VITAMIN D 400 [iU]/1 - A vitamin that includes both CHOLECALCIFEROLS and ERGOCALCIFEROLS, which have the common effect of preventing or curing RICKETS in animals. It can also be viewed as a hormone since it can be formed in SKIN by action of ULTRAVIOLET RAYS upon the precursors, 7-dehydrocholesterol and ERGOSTEROL, and acts on VITAMIN D RECEPTORS to regulate CALCIUM in opposition to PARATHYROID HORMONE.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1364855 - ascorbic acid 60 MG / cholecalciferol 0.01 MG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / thiamine 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - cyanocobalamin 4.5 MCG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG (fluoride ion 1 MG) / thiamine 1.05 MG / vitamin A 2500 UNT / vitamin B6 1.05 MG / vitamin C 60 MG / vitamin D 400 UNT / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet

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Patient Education

Vitamin B6


What is it? Vitamin B6 is a type of B vitamin. Pyridoxine, pyridoxal, and pyridoxamine are all forms of vitamin B6. It's found in certain foods and also made in a lab.

Vitamin B6 is needed for the proper function of sugars, fats, and proteins in the body. It's also necessary for the development of the brain, nerves, skin, and many other parts of the body. It's found in cereals, legumes, and eggs, and often used with other B vitamins in vitamin B complex products.

People commonly use vitamin B6 for preventing and treating vitamin B6 deficiency. It is also used for heart disease, premenstrual syndrome (PMS), depression, morning sickness, Alzheimer disease, menstrual cramps, diabetes, and many other conditions, but there is no good scientific evidence to support many of these other uses.


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".