Earache Relief

Belladonna, Calcarea Carbonica, Chamomilla, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Plantago Major, Pulsatilla (vulgaris)

The Magni Company
Human Otc Drug
NDC 43689-0020

Earache Relief also known as Belladonna, Calcarea Carbonica, Chamomilla, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Plantago Major, Pulsatilla (vulgaris) is a human otc drug labeled by 'The Magni Company'. National Drug Code (NDC) number for Earache Relief is 43689-0020. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Earache Relief drug includes Atropa Belladonna - 12 [hp_X]/1 Calcium Sulfide - 12 [hp_X]/1 Lycopodium Clavatum Spore - 12 [hp_X]/1 Matricaria Chamomilla Whole - 12 [hp_X]/1 Oyster Shell Calcium Carbonate, Crude - 12 [hp_X]/1 Plantago Major Whole - 12 [hp_X]/1 Potassium Dichromate - 12 [hp_X]/1 Pulsatilla Vulgaris Whole - 12 [hp_X]/1 . The currest status of Earache Relief drug is Active.

Drug Information:

Drug NDC:	43689-0020
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:	Earache Relief
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:	Belladonna, Calcarea Carbonica, Chamomilla, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Plantago Major, Pulsatilla (vulgaris)
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	The Magni Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	ATROPA BELLADONNA - 12 [hp_X]/1 CALCIUM SULFIDE - 12 [hp_X]/1 LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE - 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/1 PLANTAGO MAJOR WHOLE - 12 [hp_X]/1 POTASSIUM DICHROMATE - 12 [hp_X]/1 PULSATILLA VULGARIS WHOLE - 12 [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:	09 May, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 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:	The Magni Company
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:	WQZ3G9PF0H 1MBW07J51Q C88X29Y479 G0R4UBI2ZZ 2E32821G6I W2469WNO6U T4423S18FM I76KB35JEV
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
43689-0020-2	1 BOTTLE in 1 PACKAGE (43689-0020-2) / 90 TABLET in 1 BOTTLE (43689-0020-1)	24 Aug, 2016	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.

Other medicines with the same generic name

Earache Relief

Belladonna & more..

Tablet
The Magni Company
NDC: 43689-0020

Purpose:

Uses: for temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

Product Elements:

Earache relief belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla (vulgaris) atropa belladonna atropa belladonna oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude matricaria chamomilla whole matricaria chamomilla calcium sulfide calcium sulfide potassium dichromate dichromate ion lycopodium clavatum spore lycopodium clavatum spore plantago major whole plantago major pulsatilla vulgaris whole anemone pulsatilla lactose magnesium stearate cellulose, microcrystalline convex ml

Indications and Usage:

Indications: for temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

Warnings:

Warnings: â¢ if pregnant or breastfeeding, ask a health professional before use. â¢ keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. â¢ stop use and ask a doctor if you experience worsening symptoms or if symptoms last longer than 7 days.

Dosage and Administration:

Directions: adults and children 12 years and above: dissolve 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician. children under 12 years, consult a physician.

Package Label Principal Display Panel:

Package label display: magnilife homeopathic ndc 43689-0020-1 earache relief targets ear pain for fast relief soothes ear pain and discomfort due to: â allergy â cold & flu â congestion âswimmer's ear 90 dissolving tablets earache relief lbl earache relief ctn

Further Questions:

Questions: dist. by: the magni group, inc. mckinney, tx 75071 usa www.magnilife.com 1-800-645-9199

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.