Broncolin Herbal Extracts And Honey
Menthol
Broncolin, S.a. De C.v.
Human Otc Drug
NDC 62583-001Broncolin Herbal Extracts And Honey also known as Menthol is a human otc drug labeled by 'Broncolin, S.a. De C.v.'. National Drug Code (NDC) number for Broncolin Herbal Extracts And Honey is 62583-001. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Broncolin Herbal Extracts And Honey drug includes Menthol - 7.5 mg/1 . The currest status of Broncolin Herbal Extracts And Honey drug is Active.
Drug Information:
| Drug NDC: | 62583-001 |
| 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: | Broncolin Herbal Extracts And Honey |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Broncolin |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Herbal extracts and Honey |
| 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: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Broncolin, S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lozenge |
| 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: | MENTHOL - 7.5 mg/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: | OTC MONOGRAPH 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: | 01 Apr, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 May, 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: | M012 |
| 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: | 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: | BRONCOLIN, S.A. de C.V.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1250189
1495175
|
| 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: | 0714706100604
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
|
| 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 |
|---|
| 62583-001-16 | 16 LOZENGE in 1 BOX (62583-001-16) | 01 Apr, 2014 | 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:
Purpose cough suppressant/oral anesthetic
Product Elements:
Broncolin herbal extracts and honey menthol citric acid acetate sambucus nigra flower eucalyptus piperita leaf eucalyptus oil dextrose honey verbascum densiflorum flower propolis wax sucrose menthol menthol herbs and honey lozenge bee amber
Indications and Usage:
Uses temporarily relieves cough due to minor and bronchial occurring with a cold or inhaled irritants occasional minor irritation and sore throat
Warnings:
Warnings sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. these symptoms may be serious.
When Using:
When using this product do not exceed recommended dosage
Dosage and Administration:
Directions adults and children 6 years and over: dissolve 1 drop slowly in the mouth. may be repeated every hour as needed or as directed by a doctor. children under 6 years: ask a doctor
Stop Use:
Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. sore throat is severe or irritation, pain, or redness lasts or worsens sore mouth does not improve in 7 days.
Package Label Principal Display Panel:
Package label image description