NDC 55910-347 Dg Health Maximum Toothache Relief

Benzocaine, Menthol

NDC Product Code 55910-347

NDC Code: 55910-347

Proprietary Name: Dg Health Maximum Toothache Relief Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzocaine, Menthol Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 55910 - Dolgencorp, Llc
    • 55910-347 - Dg Health

NDC 55910-347-29

Package Description: 1 TUBE in 1 CARTON > 9.4 g in 1 TUBE

NDC Product Information

Dg Health Maximum Toothache Relief with NDC 55910-347 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Dg Health Maximum Toothache Relief is benzocaine, menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dolgencorp, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Dg Health Maximum Toothache Relief Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL .26 g/100g
  • BENZOCAINE 20 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SACCHARIN (UNII: FST467XS7D)
  • SORBIC ACID (UNII: X045WJ989B)
  • GLYCYRRHIZIN (UNII: 6FO62043WK)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dolgencorp, Llc
Labeler Code: 55910
FDA Application Number: part356 Additional informationCallout TooltipWhat is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-10-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dg Health Maximum Toothache Relief Product Label Images

Dg Health Maximum Toothache Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

TAMPER EVIDENT: Do not use if tube tip is cut prior to use
DISTRIBUTED BY DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072

Otc - Active Ingredient

Active ingredientsBenzocaine 20%Menthol 0.26%

Otc - Purpose

PurposeOral Pain RelieverOral Pain Reliever

Indications & Usage

  • Usefor the temporary relief of pain due to toothaches

Warnings

  • WarningsMethemoglobinemia 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:
  • Pale, gray, or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energyAllergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Otc - Do Not Use

  • Do not usemore than directedfor more than 7 days unless told to do so by a dentist or doctorfor teethingin children under 2 years of age

Otc - Stop Use

  • Stop use and ask a doctor ifswelling, rash or fever developsirritation, pain or redness persists or worsenssymptoms do not improve in 7 daysallergic reaction occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionscut open tip of tube on score markdo not use if tip is cut prior to openingadults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: do not use

Other Safety Information

  • Other informationdo not use if tip is cut prior to openingthis preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulteddo not use continuouslythis formula will stay in place for extended duration of reliefavoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredient

Inactive ingredientsammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

* Please review the disclaimer below.

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