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NDC 10191-1255 Arnica Montana (whole Plant)

Arnica Whole Plant Pellet Sublingual - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 10191-1255?
  4. Arnica Montana (whole Plant) Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes

Product Information

NDC Product Code:
10191-1255
Proprietary Name:
Arnica Montana (whole Plant)
Non-Proprietary Name: [1]
Arnica Whole Plant
Substance Name: [2]
Arnica Montana
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
    • Labeler Name: [5]
    Remedy Makers
    Labeler Code:
    10191
    Product Label ID:
    f695dfe4-3103-450a-aeef-8ea420e78df2
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    08-21-2002
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 10191-1255-2

    Package Description: 171 PELLET in 1 VIAL, GLASS

    Product Details

    What is NDC 10191-1255?

    The NDC code 10191-1255 is assigned by the FDA to the product Arnica Montana (whole Plant) which is a human over the counter drug product labeled by Remedy Makers. The generic name of Arnica Montana (whole Plant) is arnica whole plant. The product's dosage form is pellet and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 10191-1255-2 171 pellet in 1 vial, 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 Arnica Montana (whole Plant)?

    Free from yeast, wheat, corn, and soy.DIRECTIONS: Dissolve 3 or 4 pelletsin mouth or under tongue 3 times a day or as directed by a physician.Children 2 years and older take 1/2adult dose.INDICATIONS: To be used accordingto standard homeopathic indicationsfor self limiting conditions such asthose indicated on the front panel or as directed by a physician.Warnings: *Use only if cap andseal are unbroken. * Keep this and all medications out of reach of children.* If symptoms persist for more then 3days, consult your physician. *As with any drug, if your are pregnant or nursing a baby, seek the advice of ahealth professional before using this product.*Store tightly closed in a cool, dark place.Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768

    What are Arnica Montana (whole Plant) 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 Arnica Montana (whole Plant) UNII Codes?

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

    * 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".