Melatonin Forte Spray
NDC 43857-0020

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 43857-0020?
  4. Melatonin Forte Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Melatonin Forte (melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypophysis suis, hypothalamus (suis), lithium carbonicum, magnesia carbonica, pineal (suis)) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Bioactive Nutritional, Inc.. This medication is typically used as a analogs/derivatives [chemical/ingredient]. It is supplied as a spray for oral administration. This product entry covers the primary NDC 43857-0020 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43857-0020
Proprietary Name:
Melatonin Forte
Non-Proprietary Name: [1]
Melatonin, Nadidum, Niacin, Pyridoxinum Hydrochloricum, Zincum Sulphuricum, Hypophysis Suis, Hypothalamus (suis), Lithium Carbonicum, Magnesia Carbonica, Pineal (suis)
Substance Name: [2]
Lithium Carbonate; Magnesium Carbonate; Melatonin; Nadide; Niacin; Pyridoxine Hydrochloride; Sus Scrofa Hypothalamus; Sus Scrofa Pineal Gland; Sus Scrofa Pituitary Gland; Zinc Sulfate Heptahydrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Bioactive Nutritional, Inc.
Labeler Code:
43857
Product Label ID:
410861ef-3f55-4a09-888e-2123b820f878
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-04-2012
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 43857-0020?

The NDC code 43857-0020 is assigned by the FDA to the product Melatonin Forte. It is commonly known by its generic name, melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypophysis suis, hypothalamus (suis), lithium carbonicum, magnesia carbonica, pineal (suis). This pharmaceutical product is labeled by Bioactive Nutritional, Inc. and is currently categorized as listed product. The medication is a spray administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 43857-0020-1. 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?

For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle. For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.

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.
  • LITHIUM CARBONATE 8 [hp_X]/mL - A lithium salt, classified as a mood-stabilizing agent. Lithium ion alters the metabolism of BIOGENIC MONOAMINES in the CENTRAL NERVOUS SYSTEM, and affects multiple neurotransmission systems.
  • MAGNESIUM CARBONATE 8 [hp_X]/mL - RN given refers to parent cpd (1:1)
  • MELATONIN 6 [hp_X]/mL - A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.
  • NADIDE 6 [hp_X]/mL
  • NIACIN 6 [hp_X]/mL - 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 HYDROCHLORIDE 6 [hp_X]/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).
  • SUS SCROFA HYPOTHALAMUS 8 [hp_X]/mL
  • SUS SCROFA PINEAL GLAND 8 [hp_X]/mL
  • SUS SCROFA PITUITARY GLAND 8 [hp_X]/mL
  • ZINC SULFATE HEPTAHYDRATE 6 [hp_X]/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:

Which are the Pharmacologic Classes 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".