Natural Herbal Cough Drops
Menthol
Boston Nutraceutical Production, S.l
Human Otc Drug
NDC 72628-111Natural Herbal Cough Drops also known as Menthol is a human otc drug labeled by 'Boston Nutraceutical Production, S.l'. National Drug Code (NDC) number for Natural Herbal Cough Drops is 72628-111. This drug is available in dosage form of Pastille. The names of the active, medicinal ingredients in Natural Herbal Cough Drops drug includes Menthol - 4.8 mg/1 . The currest status of Natural Herbal Cough Drops drug is Active.
Drug Information:
| Drug NDC: | 72628-111 |
| 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: | Natural Herbal Cough Drops |
| 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: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Boston Nutraceutical Production, S.l |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pastille |
| 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 - 4.8 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: | 12 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| Application Number: | part341 |
| 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, 2024 |
| 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: | BOSTON NUTRACEUTICAL PRODUCTION, S.L
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 637119
|
| 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. |
| 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 |
|---|
| 72628-111-01 | 50 PASTILLE in 1 BAG (72628-111-01) | 12 May, 2021 | 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:
Purposes temporarily relieves : cough as may occur with a cold occasional minor irritation and sore throat
Product Elements:
Natural herbal cough drops menthol lemon balm oil peppermint hyssopus officinalis flowering top sage thyme wild thyme tilia cordata flower caramel horehound sucrose malva neglecta whole corn syrup menthol menthol sambucus nigra flower and herbal dark p
Indications and Usage:
Purposes temporarily relieves : cough as may occur with a cold occasional minor irritation and sore throat
Warnings:
Warnings sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. if sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. these symptons may be serious
Dosage and Administration:
Directions adults and children 6 years and over: allow 2 drops to dissolve slowly in mouth one at a time. maybe repeated every two hours as needed or as directed by a doctor. children under 6 years ask a doctor
Stop Use:
Stop use and consult doctor if cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. these could be signs of a serious conditions sore throat is severe or irritation, pain or redness lasts or worsens. sore mouth does not improve in 7 days
Overdosage:
In case of accidental overdose, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Package
Further Questions:
Questions or to report an adverse event call: 1 800 632 6800