Arnicaid

Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis


Hyland's Inc.
Human Otc Drug
NDC 54973-0229
Arnicaid also known as Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Arnicaid is 54973-0229. This drug is available in dosage form of Tablet, Soluble. The names of the active, medicinal ingredients in Arnicaid drug includes Arnica Montana - 30 [hp_X]/1 Bellis Perennis - 6 [hp_X]/1 Hypericum Perforatum - 6 [hp_X]/1 Ledum Palustre Twig - 6 [hp_X]/1 Ruta Graveolens Flowering Top - 6 [hp_X]/1 . The currest status of Arnicaid drug is Active.

Drug Information:

Drug NDC: 54973-0229
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: Arnicaid
Also known as the trade name. It is the name of the product chosen by the labeler.
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, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Soluble
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 - 30 [hp_X]/1
BELLIS PERENNIS - 6 [hp_X]/1
HYPERICUM PERFORATUM - 6 [hp_X]/1
LEDUM PALUSTRE TWIG - 6 [hp_X]/1
RUTA GRAVEOLENS FLOWERING TOP - 6 [hp_X]/1
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: 17 Jul, 1991
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 Jun, 2026
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:Hyland's Inc.
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
2HU33I03UY
XK4IUX8MNB
877L01IZ0P
N94C2U587S
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
54973-0229-150 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-0229-1)17 Jul, 1997N/ANo
54973-0229-24 TABLET, SOLUBLE in 1 POUCH (54973-0229-2)17 Jul, 1991N/AYes
54973-0229-34 POUCH in 1 CARTON (54973-0229-3) / 4 TABLET, SOLUBLE in 1 POUCH17 Jul, 1991N/ANo
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:

Active ingredients purpose arnica montana 30x hpus bruising, swelling, muscle soreness and pain bellis perennis 6x hpus swelling and sore muscles hypericum perforatum 6x hpus shooting and radiating pains ledum palustre 6x hpus pain ruta graveolens 6x hpus pain “hpus” indicates that the active ingredients are in the official homeopathic pharmacopœia of the united states.

Product Elements:

Arnicaid arnica montana, hypericum perforatum, ruta graveolens flowering top, ledum palustre twig, and bellis perennis lactose acacia arnica montana arnica montana hypericum perforatum hypericum perforatum ruta graveolens flowering top ruta graveolens flowering top ledum palustre twig ledum palustre twig bellis perennis bellis perennis

Indications and Usage:

Uses temporarily relieves symptoms of: ■ pain ■ bruising ■ muscle soreness or swelling due to minor injuries from falls, strains or sprains

Warnings:

Warnings stop use and ask a doctor if symptoms persist for more than 7 days or worsen. if pregnant or breastfeeding ask a health professional before use. keep out of reach of children

Dosage and Administration:

Directions ■ use as directed. adults and children 12 years and over at onset of symptoms, dissolve 2–3 tablets under tongue every 4 hours as needed. if the initial dosage is not providing immediate relief, dissolve 2–3 tablets under tongue every 15 minutes until relieved, up to 6 doses. children 6 years to under 12 years at onset of symptoms, dissolve 1–2 tablets under tongue every 4 hours as needed. if the initial dosage is not providing immediate relief, dissolve 1 tablet under tongue every 15 minutes until relieved, up to 6 doses.

Stop Use:

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

Package Label Principal Display Panel:

Principal display panel - 50 tablet bottle carton hyland's naturals arnicaid pain relief* minor injuries bruising & swelling 50 quick-dissolving tablets homeopathic carton


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.