Elizabeth Health Style Chestrub Vaporizing Action

Camphor (synthetic), Levomenthol, Eucalyptus

Ayushree Pharmaceuticals Private Limited
Human Otc Drug
NDC 80591-001

Elizabeth Health Style Chestrub Vaporizing Action also known as Camphor (synthetic), Levomenthol, Eucalyptus is a human otc drug labeled by 'Ayushree Pharmaceuticals Private Limited'. National Drug Code (NDC) number for Elizabeth Health Style Chestrub Vaporizing Action is 80591-001. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Elizabeth Health Style Chestrub Vaporizing Action drug includes Camphor (synthetic) - 5 g/100g Eucalyptus Oil - 1.2 g/100g Levomenthol - 2.6 g/100g . The currest status of Elizabeth Health Style Chestrub Vaporizing Action drug is Active.

Drug Information:

Drug NDC:	80591-001
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:	Elizabeth Health Style Chestrub Vaporizing Action
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:	Camphor (synthetic), Levomenthol, Eucalyptus
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Ayushree Pharmaceuticals Private Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
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:	CAMPHOR (SYNTHETIC) - 5 g/100g EUCALYPTUS OIL - 1.2 g/100g LEVOMENTHOL - 2.6 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
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:	OTC MONOGRAPH NOT FINAL
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:	28 Sep, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	28 Feb, 2024
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.
Application Number:	part348
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	10 May, 2026
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:	AYUSHREE PHARMACEUTICALS PRIVATE LIMITED
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2397992
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0857099005665
UPC stands for Universal Product Code.
UNII:	5TJD82A1ET 2R04ONI662 BZ1R15MTK7
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
80591-001-01	113 g in 1 DRUM (80591-001-01)	28 Sep, 2020	28 Feb, 2024	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

Elizabeth Health Style Chestrub Vaporizing Action

Camphor (synthetic), Levomenthol, Eucalyptus

Ointment
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED
NDC: 80591-001

Elizabeth Health Style Chestrub Vaporizing Action

Camphor (synthetic), Levomenthol, Eucalyptus

Ointment
Singhfam Corporation
NDC: 52920-135

Purpose:

Product Elements:

Elizabeth health style chestrub vaporizing action camphor (synthetic), levomenthol, eucalyptus butylated hydroxytoluene cedar leaf oil paraffin light mineral oil microcrystalline wax nutmeg oil white pine oil thymol camphor (synthetic) camphor (synthetic) levomenthol levomenthol eucalyptus oil eucalyptus oil

Indications and Usage:

Use temporarily relieves symptoms associated with the common cold: cough nasal congestion chest congestion temporarily relieves minor aches and pains of muscles.

Warnings:

Warnings for external use only. avoid contact with eyes. ask a doctor before use if you have cough with excessive phlegm (mucus) chronic cough that lasts or as occurs with smoking, asthma or emphysema. when using this product do not heat microwave add to hot water or any container where heating water. may cause splattering and result in burns. muscle aches and pains persist for more than 7 days or come back. cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. these could be sign of a serious condition if pregnant or breast-feeding , consult a physician before use.

Dosage and Administration:

Directions see important warnings under "do not use this product". children under 2 years of age, ask a doctor. adults and children 2 years of age or older: rub a thick layer on chest and throat. if desired. loosely cover with a soft dry cloth but keep clothing loose. repeat up to 3 times daily, or as directed by a doctor.

Package Label Principal Display Panel:

Package label - principal display panel label

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.