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  4. NDC Product Code: 81279-100 Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops

NDC 81279-100 Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops

Vitamin A (as Retinyl Palmitate) Vitamin C (as Ascorbic Acid) Vitamin D3 (as - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 81279-100?
  5. Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
81279-100
Proprietary Name:
Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops
Non-Proprietary Name: [1]
Vitamin A (as Retinyl Palmitate) Vitamin C (as Ascorbic Acid) Vitamin D3 (as Cholecalciferol) Vitamin E (as D-alpha-tocopherol Acetate) Vitamin B1 (as Thiamine Hcl) Vitamin B2 (as Riboflavin Phosphate Sodium) Niacin (as Niacinamide) Vitamin B6 (pyridoxine Hcl) Folate (as 69 Mcg Quatrefolic ((6s)-5 Methyltetrahydrofolate, Glucosamine Salt, Molar Equivalent To 37.5 Mcg Of Folic Acid)) Vitamin B12 (as Cyanocobalamin) Fluoride (as Sodium Fluoride)
Substance Name: [2]
.alpha.-tocopherol Acetate; Ascorbic Acid; Cholecalciferol; Cyanocobalamin; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Sodium Fluoride; Thiamine Hydrochloride; Vitamin A Palmitate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Pangea Pharmaceuticals, Llc
    Labeler Code:
    81279
    Product Label ID:
    263e77a5-4d0e-4cec-b2d8-04fd28ce3338
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    12-20-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    Flavor(s):
    GRAPE (C73391)

    Code Structure Chart

    Product Details

    What is NDC 81279-100?

    The NDC code 81279-100 is assigned by the FDA to the product Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops which is a human prescription drug product labeled by Pangea Pharmaceuticals, Llc. The generic name of Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops is vitamin a (as retinyl palmitate) vitamin c (as ascorbic acid) vitamin d3 (as cholecalciferol) vitamin e (as d-alpha-tocopherol acetate) vitamin b1 (as thiamine hcl) vitamin b2 (as riboflavin phosphate sodium) niacin (as niacinamide) vitamin b6 (pyridoxine hcl) folate (as 69 mcg quatrefolic ((6s)-5 methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of folic acid)) vitamin b12 (as cyanocobalamin) fluoride (as sodium fluoride). The product's dosage form is solution/ drops and is administered via oral form. The product is distributed in a single package with assigned NDC code 81279-100-50 1 bottle, dropper in 1 carton / 50 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops?

    Florafol™ Pediatric 0.25 mg/mL Fluoride, is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.

    What are Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops Active Ingredients?

    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 3.35 mg/mL - A natural tocopherol and one of the most potent antioxidant tocopherols. It exhibits antioxidant activity by virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus. It has four methyl groups on the 6-chromanol nucleus. The natural d form of alpha-tocopherol is more active than its synthetic dl-alpha-tocopherol racemic mixture.
    • ASCORBIC ACID 36 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 10 ug/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
    • FOLIC ACID 117 ug/mL - 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.
    • NIACINAMIDE 4 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 .6 mg/mL - 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 .25 mg/mL - A source of inorganic fluoride which is used topically to prevent dental caries.
    • THIAMINE HYDROCHLORIDE .5 mg/mL
    • VITAMIN A PALMITATE 450 ug/mL

    Which are Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops UNII Codes?

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

    Which are Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops Inactive Ingredients 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:

    Which are the Pharmacologic Classes for Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops?

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".