Severe Throat Sore Drops
Menthol
Target Corporation Inc.
Human Otc Drug
NDC 11673-143Severe Throat Sore Drops also known as Menthol is a human otc drug labeled by 'Target Corporation Inc.'. National Drug Code (NDC) number for Severe Throat Sore Drops is 11673-143. This drug is available in dosage form of Pastille. The names of the active, medicinal ingredients in Severe Throat Sore Drops drug includes Menthol - .69 mg/1 . The currest status of Severe Throat Sore Drops drug is Active.
Drug Information:
| Drug NDC: | 11673-143 |
| 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: | Severe Throat Sore 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: | Target Corporation Inc. |
| 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 - .69 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 Oct, 2019 |
| 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: | Target Corporation 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. |
| 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 |
|---|
| 11673-143-01 | 45 PASTILLE in 1 BAG (11673-143-01) | 12 Oct, 2019 | 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:
Temporarily relieves ocassional minor irritation and pain due to: sore throat sore mouth
Product Elements:
Severe throat sore drops menthol eucalyptus oil fd&c blue no. 1 water acacia sucrose corn syrup menthol menthol with menthol drops none
Indications and Usage:
Temporarily relieves ocassional minor irritation and pain due to: sore throat sore mouth
Warnings:
Warnings sore throat warning: severe or persistence sore throat accompanied or followed by high fever, headache, nausea and vomiting may be serious. consult a doctor promptly. do not use more than 2 days or administer to children under 12 years of age.
Dosage and Administration:
Directions adults and children 12 years and over: dissolve 1 drop slowly in mouth. repeated every 2 hours as needed or as directed by a doctor. children under 12 years and under do not use
Stop Use:
Stop use and consult a doctor if sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Overdosage:
In case of accidental overdose, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Front label
Further Questions:
Questions? or to report and adverse event call: 1-617-848-4560 monday to friday 9am to 4 pm east