Equate Severe Toothache And Gum Relief

Benzocaine, Menthol, Benzalkonium Chloride

Wal-mart Stores Inc
Human Otc Drug
NDC 49035-361

Equate Severe Toothache And Gum Relief also known as Benzocaine, Menthol, Benzalkonium Chloride is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Equate Severe Toothache And Gum Relief is 49035-361. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Equate Severe Toothache And Gum Relief drug includes Benzalkonium Chloride - .1 g/100g Benzocaine - 20 g/100g Menthol - .5 g/100g . The currest status of Equate Severe Toothache And Gum Relief drug is Active.

Drug Information:

Drug NDC:	49035-361
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:	Equate Severe Toothache And Gum Relief
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:	Benzocaine, Menthol, Benzalkonium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Wal-mart Stores Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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:	BENZALKONIUM CHLORIDE - .1 g/100g BENZOCAINE - 20 g/100g MENTHOL - .5 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	DENTAL
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:	02 Nov, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	12 Jul, 2023
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:	15 May, 2026
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:	Wal-Mart Stores Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1543432
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.
NUI:	N0000185508 N0000175629 N0000184306 M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	F5UM2KM3W7 U3RSY48JW5 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.
Pharmacologic Class EPC:	Standardized Chemical Allergen [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Standardized Chemical Allergen [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
49035-361-19	1 TUBE in 1 BOX (49035-361-19) / 7 g in 1 TUBE	02 Nov, 2018	12 Jul, 2023	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.

Other medicines with the same generic name

Equate Severe Toothache And Gum Relief

Benzocaine, Menthol, Benzalkonium Chloride

Gel
Wal-Mart Stores Inc
NDC: 49035-361

Purpose:

Purpose oral pain reliever oral pain reliever antiseptic

Product Elements:

Equate severe toothache and gum relief benzocaine, menthol, benzalkonium chloride carboxymethylcellulose sodium, unspecified form pectin gelatin mineral oil fd&c blue no. 1 petrolatum saccharin sodium saccharin polyethylene glycol, unspecified methyl salicylate benzalkonium chloride benzalkonium benzocaine benzocaine menthol menthol

Indications and Usage:

Use Â· for the temporary relief of pain due to toothaches Â· to help protect against infection of minor oral irritation

Warnings:

Warnings methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: â¢ pale, gray, or blue colored skin (cyanosis) â¢ headache â¢ rapid heart rate â¢ shortness of breath â¢ dizziness or lightheadedness â¢ fatigue or lack of energy

Do Not Use:

Dosage and Administration:

Directions â¢ cut open tip of tube on score mark â¢ adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. use up to 4 times daily or as directed by a dentist or doctor â¢ children between 2 and 12 years of age should be supervised in the use of this product â¢ children under 2 years of age: do not use

Stop Use:

Stop use and ask a doctor if â¢ swelling, rash or fever develops â¢ irritation, pain or redness persists or worsens â¢ symptoms do not improve in 7 days â¢ allergic reaction occurs

Package Label Principal Display Panel:

Equate triple medicated severe toothache & gum relief oral pain reliever / antiseptic immediate relief of intense pain maximum strength benzocaine for toothache pain relief antiseptic to help prevent infection soothing menthol for gums fast acting gel compare to orajelâ¢ severe triple medicated gel active ingredients* satisfaction guaranteed - or we'll replace it or give you your money back. for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. distributed by: wal-mart stores, inc. bentonville, ar 72716 *this product is not manufactured or distributed by church & dwight co. inc., makers of orajelâ¢. tamper-evident: do not use if tube tip is cut prior to use label

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.