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  4. NDC Product Code: 44911-0555 Dentastat

NDC 44911-0555 Dentastat

Allium Sativum,Berberis Vulgaris,Fucus Vesiculosus,Phytolacca Decandra,Argentum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 44911-0555?
  4. Dentastat Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
44911-0555
Proprietary Name:
Dentastat
Non-Proprietary Name: [1]
Allium Sativum, Berberis Vulgaris, Fucus Vesiculosus, Phytolacca Decandra, Argentum Metallicum, Aurum Metallicum, Calcarea Fluorica, Calcarea Phosphorica, Iodium, Mercurius Solubilis, Niccolum Metallicum, Silicea, Zincum Metallicum, Platinum Metallicum
Substance Name: [2]
Berberis Vulgaris Root Bark; Calcium Fluoride; Fucus Vesiculosus; Garlic; Gold; Iodine; Mercurius Solubilis; Nickel; Phytolacca Americana Root; Platinum; Silicon Dioxide; Silver; Tribasic Calcium Phosphate; Zinc
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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 Name: [5]
    Energique, Inc.
    Labeler Code:
    44911
    Product Label ID:
    acfadaf0-60e4-4268-8b5b-8d26fdd871d7
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    08-12-2020
    End Marketing Date: [10]
    08-25-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 44911-0555?

    The NDC code 44911-0555 is assigned by the FDA to the product Dentastat which is a human over the counter drug product labeled by Energique, Inc.. The generic name of Dentastat is allium sativum, berberis vulgaris, fucus vesiculosus, phytolacca decandra, argentum metallicum, aurum metallicum, calcarea fluorica, calcarea phosphorica, iodium, mercurius solubilis, niccolum metallicum, silicea, zincum metallicum, platinum metallicum. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 44911-0555-1 30 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 Dentastat?

    May temporarily relieve symptoms associated with dental procedures, such as pain and minor inflammation in the mouth or on the gums.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. May temporarily relieve symptoms associated with dental procedures, such as pain and minor inflammation in the mouth or on the gums.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    What are Dentastat 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.
    • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
    • CALCIUM FLUORIDE 12 [hp_X]/mL - Calcium fluoride. Occurring in nature as the mineral fluorite or fluorspar. It is the primary source of fluorine and its compounds. Pure calcium fluoride is used as a catalyst in dehydration and dehydrogenation and is used to fluoridate drinking water. (From Merck Index, 11th ed)
    • FUCUS VESICULOSUS 3 [hp_X]/mL - A genus of BROWN ALGAE in the family Fucaceae. It is found in temperate, marine intertidal areas along rocky coasts and is a source of ALGINATES. Some species of Fucus are referred to as KELP.
    • GARLIC 3 [hp_X]/mL - A species of Allium used as a spice (SPICES) and traditional remedy. It contains alliin lyase and alliin, which is converted by alliin lyase to allicin, the pungent ingredient responsible for the aroma of fresh cut garlic.
    • GOLD 12 [hp_X]/mL - A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.
    • IODINE 12 [hp_X]/mL - A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically.
    • MERCURIUS SOLUBILIS 12 [hp_X]/mL
    • NICKEL 12 [hp_X]/mL - A trace element with the atomic symbol Ni, atomic number 28, and atomic weight 58.69. It is a cofactor of the enzyme UREASE.
    • PHYTOLACCA AMERICANA ROOT 6 [hp_X]/mL
    • PLATINUM 16 [hp_X]/mL - A heavy, soft, whitish metal, resembling tin, with atomic number 78, atomic weight 195.084, symbol Pt. It is used in manufacturing equipment for laboratory and industrial use. It occurs as a black powder (platinum black) and as a spongy substance (spongy platinum) and may have been known in Pliny's time as "alutiae".
    • SILICON DIOXIDE 12 [hp_X]/mL - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.
    • SILVER 12 [hp_X]/mL - An element with the atomic symbol Ag, atomic number 47, and atomic weight 107.87. It is a soft metal that is used medically in surgical instruments, dental prostheses, and alloys. Long-continued use of silver salts can lead to a form of poisoning known as ARGYRIA.
    • TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/mL
    • ZINC 12 [hp_X]/mL - A metallic element of atomic number 30 and atomic weight 65.38. It is a necessary trace element in the diet, forming an essential part of many enzymes, and playing an important role in protein synthesis and in cell division. Zinc deficiency is associated with ANEMIA, short stature, HYPOGONADISM, impaired WOUND HEALING, and geophagia. It is known by the symbol Zn.

    Which are Dentastat UNII Codes?

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

    Which are Dentastat 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:

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    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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".