Arnica Montana 7103
Arnica Montana
Professional Complementary Health Formulas
Human Otc Drug
NDC 63083-7103Arnica Montana 7103 also known as Arnica Montana is a human otc drug labeled by 'Professional Complementary Health Formulas'. National Drug Code (NDC) number for Arnica Montana 7103 is 63083-7103. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Arnica Montana 7103 drug includes Arnica Montana Whole - 6 [hp_X]/29.5mL . The currest status of Arnica Montana 7103 drug is Active.
Drug Information:
Drug NDC: | 63083-7103 |
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
Proprietary Name: | Arnica Montana 7103 |
Also known as the trade name. It is the name of the product chosen by the labeler. |
Proprietary Name Base: | Arnica Montana |
The base of the Brand/Proprietary name excluding its suffix. |
Proprietary Name Suffix: | 7103 |
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
Product Type: | Human Otc Drug |
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
Non Proprietary Name: | Arnica Montana |
Also known as the generic name, this is usually the active ingredient(s) of the product. |
Labeler Name: | Professional Complementary Health Formulas |
Name of Company corresponding to the labeler code segment of the ProductNDC. |
Dosage Form: | Liquid |
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
Status: | Active |
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
Substance Name: | ARNICA MONTANA WHOLE - 6 [hp_X]/29.5mL
|
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
Route Details: | ORAL
|
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: | UNAPPROVED HOMEOPATHIC |
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
Marketing Start Date: | 15 Aug, 1984 |
This is the date that the labeler indicates was the start of its marketing of the drug product. |
Marketing End Date: | 15 Jan, 2025 |
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. |
Listing Expiration Date: | 31 Dec, 2023 |
This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name: | Professional Complementary Health Formulas
|
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
Original Packager: | Yes
|
Whether or not the drug has been repackaged for distribution. |
UNII: | O80TY208ZW
|
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
---|
63083-7103-1 | 29.5 mL in 1 BOTTLE, DROPPER (63083-7103-1) | 15 Aug, 1985 | N/A | No |
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
*claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.
Product Elements:
Arnica montana 7103 arnica montana arnica montana whole arnica montana whole alcohol water
Indications and Usage:
Indications use according to standard homeopathic indications for self-limiting conditions. common materia medica indications: minor injuries, bruises, sprains, exhaustion, headache.*
Warnings:
Warnings in case of overdose, get medical help or contact a poison control center right away. keep out of the reach of children. if pregnant or breastfeeding, ask a healthcare professional before use.
Dosage and Administration:
Directions place drops under tongue 30 minutes before/after meals. adults and children 12 years and over: take 10 drops up to 3 times per day. consult a physician for use in children under 12 years of age.
Package Label Principal Display Panel:
Label est 1985 professional formulas complementary health arnica montana homeopathic remedy 1 fl. oz. (29.5 ml) label image
Further Questions:
Questions professional formulas po box 2034 lake oswego, or 97035