Vicks Vapocool Severe
Menthol
The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 37000-894Vicks Vapocool Severe also known as Menthol is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Vicks Vapocool Severe is 37000-894. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Vicks Vapocool Severe drug includes Menthol - 20 mg/1 . The currest status of Vicks Vapocool Severe drug is Active.
Drug Information:
| Drug NDC: | 37000-894 |
| 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: | Vicks Vapocool Severe |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Vicks Vapocool |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Severe |
| 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: | The Procter & Gamble Manufacturing Company |
| 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 - 20 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 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: | 29 Dec, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| 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: | part356 |
| 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: | The Procter & Gamble Manufacturing Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1995300
|
| 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 |
|---|
| 37000-894-18 | 18 POUCH in 1 BAG (37000-894-18) / 1 LOZENGE in 1 POUCH | 29 Dec, 2017 | N/A | No |
| 37000-894-20 | 200 POUCH in 1 BAG (37000-894-20) / 1 LOZENGE in 1 POUCH | 09 Jul, 2019 | N/A | No |
| 37000-894-45 | 45 POUCH in 1 BAG (37000-894-45) / 1 LOZENGE in 1 POUCH | 29 Dec, 2017 | 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 oral anesthetic
Product Elements:
Vicks vapocool severe menthol sucrose acacia potassium sorbate glycerin fd&c blue no. 1 corn syrup eucalyptol water menthol menthol with blue specks vicks
Indications and Usage:
Uses relieves occasional minor irritation and pain due to sore throat sore mouth
Warnings:
Warnings sore throat warning severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult doctor promptly. do not use more than 2 days or administer to children under 5 years of age unless directed by doctor. ask a doctor before use if you have a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away
Dosage and Administration:
Directions adults and children 12 years and over: dissolve 1 drop slowly in the mouth. repeat every 2 hours as needed or as directed by a doctor. children 12 years and under: do not use
Stop Use:
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.
Package Label Principal Display Panel:
Principal display panel - 20 drop bag max strength vicks ® vapocool ⢠severe menthol ·oral anesthetic winterfrost powerful rush of vicks vapors soothes sore throats 33% more medicine* 18 medicated drops 894
Further Questions:
Questions? 1-800-707-1709