Multi-vitamin Drops With Fluoride And Iron Liquid
NDC 58657-327

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58657-327?
  5. Multi-vitamin Drops With Fluoride And Iron Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Multi-vitamin Drops With Fluoride And Iron (vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, ferrous sulfate and sodium fluoride) is a UNAPPROVED DRUG OTHER-approved product labeled by Method Pharmaceuticals, Llc. This medication is typically used as a analogs/derivatives [chemical/ingredient]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 58657-327 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58657-327
Proprietary Name:
Multi-vitamin Drops With Fluoride And Iron
Non-Proprietary Name: [1]
Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Niacinamide, Pyridoxine Hydrochloride, Ferrous Sulfate And Sodium Fluoride
Substance Name: [2]
.alpha.-tocopherol Succinate, D-; Ascorbic Acid; Cholecalciferol; Ferrous Sulfate; 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:
d5609742-e456-4409-bca9-706b0ea90d35
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 58657-327?

The NDC code 58657-327 is assigned by the FDA to the product Multi-vitamin Drops With Fluoride And Iron. It is commonly known by its generic name, vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, ferrous sulfate 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: 58657-327-50. 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?

Supplementation of the diet with vitamins A, C and D.Multi-Vitamin Drops with Fluoride and Iron 0.25 mg also provides fluoride for caries prophylaxis.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 supplementation.The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration).Multi-Vitamin Drops with Fluoride and Iron 0.25 mg supply significant amounts of vitamins A, C and D 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 essential vitamins and fluoride.

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.
  • FERROUS SULFATE 10 mg/mL - Ferro-Gradumet is ferrous sulfate in controlled release form; RN given refers to Fe(+2)[1:1] salt
  • 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:

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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".