Antiseptic

Eucalyptol, Menthol, Methyl Salicylate, Thymol


Walmart Inc. (see Also Equate)
Human Otc Drug
NDC 79903-152
Antiseptic also known as Eucalyptol, Menthol, Methyl Salicylate, Thymol is a human otc drug labeled by 'Walmart Inc. (see Also Equate)'. National Drug Code (NDC) number for Antiseptic is 79903-152. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Antiseptic drug includes Eucalyptol - .92 mg/mL Menthol - .42 mg/mL Methyl Salicylate - .6 mg/mL Thymol - .64 mg/mL . The currest status of Antiseptic drug is Active.

Drug Information:

Drug NDC: 79903-152
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: Antiseptic
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: Eucalyptol, Menthol, Methyl Salicylate, Thymol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Walmart Inc. (see Also Equate)
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:EUCALYPTOL - .92 mg/mL
MENTHOL - .42 mg/mL
METHYL SALICYLATE - .6 mg/mL
THYMOL - .64 mg/mL
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: 30 Dec, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 04 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, 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:WALMART INC. (see also Equate)
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1043619
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:0681131430395
UPC stands for Universal Product Code.
UNII:RV6J6604TK
L7T10EIP3A
LAV5U5022Y
3J50XA376E
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
79903-152-751500 mL in 1 BOTTLE, PLASTIC (79903-152-75)30 Dec, 2022N/ANo
79903-152-992 BOTTLE, PLASTIC in 1 PACKAGE (79903-152-99) / 1500 mL in 1 BOTTLE, PLASTIC30 Dec, 2022N/ANo
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 antiplaque/antigingivitis

Product Elements:

Antiseptic eucalyptol, menthol, methyl salicylate, thymol eucalyptol eucalyptol menthol menthol methyl salicylate salicylic acid thymol thymol water alcohol sorbitol poloxamer 407 trisodium citrate dihydrate benzoic acid saccharin sodium fd&c green no. 3 d&c yellow no. 10

Indications and Usage:

Uses helps prevent and reduce plaque gingivitis

Warnings:

Warning do not use in children under 12 years of age. stop use and ask a dentist gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. these may be signs or symptoms of periodontitis, a serious form of gum disease. keep out of reach of children under 6 years of age if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center (1-800-222-1222) right away

Do Not Use:

Warning do not use in children under 12 years of age. stop use and ask a dentist gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. these may be signs or symptoms of periodontitis, a serious form of gum disease. keep out of reach of children under 6 years of age if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center (1-800-222-1222) right away

Dosage and Administration:

Directions adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. do not swallow the rinse. children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Stop Use:

Stop use and ask a dentist gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. these may be signs or symptoms of periodontitis, a serious form of gum disease.

Package Label Principal Display Panel:

Principal display panel compare to listerine® freshburst® active ingredients* antiseptic mouthwash eucalyptol (0.092%) menthol (0.042%) methyl salicylate (0.060%) thymol (0.064%) antiplaque/antigingivitis kills germs that cause plaque, gingivitis, bad breath help to control and prevent plaque that leads to gingivitis mint blast l (qt pt fl oz) *this product is not manufactured or distributed by johnson & johnson consumer inc., distributor of listerine® freshburst®. tamper evident: do not use if printed safety seal around bottle or under cap is broken or missing. distributed by: walmart inc., bentonville, ar 72716

Package label equate antiseptic mouthwash mint blast eucalyptol (0.092%), menthol (0.042%), methyl salicylate (0.060%), thymol (0.064%

Further Questions:

Questions or comments 1-888-287-1915


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.