Multi-vitamin With Fluoride Liquid
NDC 58657-325

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58657-325?
  5. Multi-vitamin 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

Multi-vitamin With Fluoride (vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride) 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 liquid for oral administration. This product entry covers the primary NDC 58657-325 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58657-325
Proprietary Name:
Multi-vitamin With Fluoride
Non-Proprietary Name: [1]
Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Cyanocobalamin, Niacinamide, Pyridoxine Hydrochloride And Sodium Fluoride
Substance Name: [2]
.alpha.-tocopherol Succinate, D-; Ascorbic Acid; Cholecalciferol; Cyanocobalamin; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-phosphate Sodium; Sodium Fluoride; Thiamine Hydrochloride; Vitamin A Palmitate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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:
880df628-5bba-4dc4-b557-1fcc822adba8
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]
02-24-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 58657-325?

The NDC code 58657-325 is assigned by the FDA to the product Multi-vitamin With Fluoride. It is commonly known by its generic name, vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride. This pharmaceutical product is labeled by Method Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58657-325-50. 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 SUCCINATE, D- 5 [iU]/mL
  • ASCORBIC ACID 35 mg/mL - 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.
  • CHOLECALCIFEROL 400 [iU]/mL - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
  • CYANOCOBALAMIN 2 ug/mL
  • NIACINAMIDE 8 mg/mL - An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
  • PYRIDOXINE HYDROCHLORIDE .4 mg/mL - 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 5'-PHOSPHATE SODIUM .6 mg/mL
  • SODIUM FLUORIDE .25 mg/mL - A source of inorganic fluoride which is used topically to prevent dental caries.
  • THIAMINE HYDROCHLORIDE .5 mg/mL
  • VITAMIN A PALMITATE 1500 [iU]/mL

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: 1234482 - ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / niacin 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / thiamine 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution
  • RxCUI: 1234482 - ascorbic acid 35 MG / cholecalciferol 400 UNT / niacin 8 MG / riboflavin 0.6 MG / sodium fluoride 0.55 MG (fluoride 0.25 MG) / thiamine 0.5 MG / vitamin A 1500 UNT / vitamin B 12 2 MCG / vitamin B6 0.4 MG / vitamin E 5 UNT per ML Oral Solution
  • RxCUI: 1234482 - vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution
  • RxCUI: 1234482 - vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution
  • RxCUI: 1234482 - vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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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]


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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".