Tri-vite Drops With Fluoride Solution
NDC 58657-324

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58657-324?
  5. Tri-vite Drops With Fluoride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Tri-vite Drops With Fluoride (ascorbic acid, sodium fluoride, vitamin a and vitamin d) is a UNAPPROVED DRUG OTHER-approved product labeled by Method Pharmaceuticals, Llc. This medication is typically used as a ascorbic acid [cs]. It is supplied as a brown solution for oral administration. This product entry covers the primary NDC 58657-324 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58657-324
Proprietary Name:
Tri-vite Drops With Fluoride
Non-Proprietary Name: [1]
Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D
Substance Name: [2]
Ascorbic Acid; Sodium Fluoride; 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:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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:
5acff360-8d44-44d7-864d-52f213501d03
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]
07-25-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BROWN (C48332 - CARAMEL COLOR)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 58657-324?

The NDC code 58657-324 is assigned by the FDA to the product Tri-vite Drops With Fluoride. It is commonly known by its generic name, ascorbic acid, sodium fluoride, 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 solution administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58657-324-50. 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. Tri-Vite Drops with Fluoride 0.5 mg also provides fluoride for caries prophylaxis.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 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.5 mg (See Dosage and Administration).Tri-Vite Drops with Fluoride 0.5 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.
  • 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.
  • SODIUM FLUORIDE .5 mg/mL - A source of inorganic fluoride which is used topically to prevent dental caries.
  • VITAMIN A 1500 [iU]/mL - 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]/mL - 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: 1365984 - ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
  • RxCUI: 1365984 - ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / retinyl palmitate 1500 UNT/ML / sodium fluoride 1.1 MG/ML Oral Solution
  • RxCUI: 1365984 - sodium fluoride 1.1 MG (fluoride ion 0.5 MG) / vitamin A palmitate 1500 UNT / vitamin C 35 MG / vitamin D3 0.01 MG (400 UNT) per ML Oral Solution
  • RxCUI: 1365984 - vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
  • RxCUI: 1365984 - vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 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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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".