Earache Remedy

Ear Drops

Vitality Works, Inc.
Human Otc Drug
NDC 64616-045

Earache Remedy also known as Ear Drops is a human otc drug labeled by 'Vitality Works, Inc.'. National Drug Code (NDC) number for Earache Remedy is 64616-045. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Earache Remedy drug includes Aconitum Napellus - 6 [hp_X]/mL Atropa Belladonna - 3 [hp_X]/mL Matricaria Recutita - 6 [hp_X]/mL Plantago Major - 3 [hp_X]/mL Potassium Chloride - 3 [hp_X]/mL Verbascum Thapsus - 6 [hp_X]/mL . The currest status of Earache Remedy drug is Active.

Drug Information:

Drug NDC:	64616-045
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 Remedy
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:	Ear Drops
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Vitality Works, Inc.
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:	ACONITUM NAPELLUS - 6 [hp_X]/mL ATROPA BELLADONNA - 3 [hp_X]/mL MATRICARIA RECUTITA - 6 [hp_X]/mL PLANTAGO MAJOR - 3 [hp_X]/mL POTASSIUM CHLORIDE - 3 [hp_X]/mL VERBASCUM THAPSUS - 6 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	AURICULAR (OTIC)
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:	23 Aug, 2004
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 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:	Vitality Works, 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.
UPC:	0019277000439
UPC stands for Universal Product Code.
UNII:	U0NQ8555JD WQZ3G9PF0H G0R4UBI2ZZ W2469WNO6U 660YQ98I10 C9TD27U172
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.
Pharmacologic Class:	Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
64616-045-02	1 BOTTLE, DROPPER in 1 CARTON (64616-045-02) / 15 mL in 1 BOTTLE, DROPPER (64616-045-01)	09 Dec, 2005	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

Pediatric Earache Remedy

Ear Drops

Liquid
Vitality Works, Inc
NDC: 64616-050

Earache Remedy

Ear Drops

Liquid
Vitality Works, Inc.
NDC: 64616-045

Purpose:

Earache remedy aconitum napellus - relieves earache, hot, painful, swollen ear. belladonna - relieves otitis media, throbbing deep ear pain. chamomilla - relieves eache, soreness, swelling, otalgia. kali mur - relieves chronic catarrahal conditions of middle ear. plantago major - relieves earache, neuralgic earache, otalgia. verbascum - relieves catarrhs, otalgia with sense of obstruction.

Product Elements:

Earache remedy ear drops benzalkonium chloride olea europaea leaf water aconitum napellus aconitum napellus atropa belladonna atropa belladonna potassium chloride potassium cation plantago major plantago major matricaria recutita matricaria recutita verbascum thapsus verbascum thapsus cobalt disodium edetate

Indications and Usage:

Earache remedy a homeopathic combination for the temporary relief or earaches, inflammation of the external and internal ear. for the temporary relief of earches from congestion or swelling of middle ear or eustacian tubes.

Warnings:

Earache remedy keep this and all medicines out of reach of children. before use with children under 3 years of age, or if you are pregnant or nursing seek the advice of your health care professional. avoid contact with eyes. if symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. in case of accedental overdose, seek professional assistance or contact a poison control center immediately. all the ingredients are edible but this is not intended for internal use.

Dosage and Administration:

Warm up bottle by gently rolling it between your hands before use. tilt head sideways and place 2 to 3 drops into ear. tip of applicator should not enter ear canal. repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.

Package Label Principal Display Panel:

Earache remedy label 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.