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NDC 55714-4789 Oral Care-gingivitis

Aconitum Nap.,Arnica,Arsenicum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 55714-4789?
  4. Oral Care-gingivitis Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
55714-4789
Proprietary Name:
Oral Care-gingivitis
Non-Proprietary Name: [1]
Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus, Crotalus Horridus, Gelsemium, Hepar Sulph. Calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Silicea, Staphysag., Echinacea
Substance Name: [2]
Aconitum Napellus; Arnica Montana; Arsenic Trioxide; Atropa Belladonna; Baptisia Tinctoria Root; Bryonia Alba Root; Calcium Sulfide; Calendula Officinalis Flowering Top; Chelidonium Majus; Crotalus Horridus Horridus Venom; Delphinium Staphisagria Seed; Echinacea, Unspecified; Gelsemium Sempervirens Root; Matricaria Chamomilla; Mercury; Myrrh; Phosphorus; Phytolacca Americana Root; Plantago Major; Silicon Dioxide; Strychnos Nux-vomica Seed; Toxicodendron Pubescens Leaf; Wood Creosote
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]
    Newton Laboratories, Inc.
    Labeler Code:
    55714
    Product Label ID:
    9971a7f4-c02c-02ba-e053-2a95a90a2b73
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    09-02-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 55714-4789?

    The NDC code 55714-4789 is assigned by the FDA to the product Oral Care-gingivitis which is a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Oral Care-gingivitis is aconitum nap., arnica, arsenicum alb., baptisia, belladonna, bryonia, calendula, chamomilla, chelidonium majus, crotalus horridus, gelsemium, hepar sulph. calc., kreosotum, merc. viv., myrrha, nux vom., phosphorus, phytolacca, plantago, rhus toxicodendron, silicea, staphysag., echinacea. 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 55714-4789-1 30 ml in 1 bottle, glass . 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 Oral Care-gingivitis?

    Formulated for symptoms associated with periodontal conditions such as gingivitis, halitosis, teeth pain and gum sensitivity.

    What are Oral Care-gingivitis 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.

    Which are Oral Care-gingivitis UNII Codes?

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

    Which are Oral Care-gingivitis 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 Oral Care-gingivitis?

    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.

    * 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".