Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant
Menthol
Lofthouse Of Fleetwood, Ltd.
Human Otc Drug
NDC 55711-070Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant also known as Menthol is a human otc drug labeled by 'Lofthouse Of Fleetwood, Ltd.'. National Drug Code (NDC) number for Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant is 55711-070. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant drug includes Menthol - 6.9 mg/1 . The currest status of Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant drug is Active.
Drug Information:
| Drug NDC: | 55711-070 |
| 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: | Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant |
| 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: | Lofthouse Of Fleetwood, Ltd. |
| 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 - 6.9 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: | 10 Aug, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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, 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: | Lofthouse of Fleetwood, Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1052744
1052746
|
| 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 |
|---|
| 55711-070-01 | 20 LOZENGE in 1 PACKET (55711-070-01) | 10 Aug, 2010 | 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:
Sugar free cherry fishermans friend menthol cough suppressant menthol sorbitol magnesium stearate sucralose acesulfame potassium menthol menthol red speckles ff
Indications and Usage:
Uses temporarily relieves occasional minor sore throat cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
Warnings:
Warnings sore throat warning: severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomitting may be serious. ask a doctor right away. do not use more than 2 days or give to children under 2 years of age unless directed by a doctor. ask a doctor before use if you have cough that occurs with too much phlegm (mucus) a persistent or chronic cough that lasts such as occurs with smoking, ashtma, or emphysema when using this product do not use more than directed stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition sore throat is severe, lasts more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomitting if pregnant or breast-feeding , ask a health professional before use keep out of reach of children
When Using:
When using this product do not use more than directed
Dosage and Administration:
Directions adults and children 2 years of age and over: allow 1 lozenge to dissolve slowly in the mouth repeat every 2 hours as needed or as directed by a doctor children under 2 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. these could be signs of a serious condition sore throat is severe, lasts more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomitting
Package Label Principal Display Panel:
Fisherman's friend ® cherry menthol cough suppressant lozenges cough suppressant/oral anesthetic 20 lozenges manufactured by: lofthouse of fleetwood ltd., lancs., england distributed by: greenwood brands, llc. buffalo-niagara, ny 14225 ffinfo@greenwoodg.com label