NDC 76357-409 Smartmouth Mouth Sore Zinc Activated Formula

Menthol, Unspecified Form

NDC Product Code 76357-409

NDC CODE: 76357-409

Proprietary Name: Smartmouth Mouth Sore Zinc Activated Formula What 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: Menthol, Unspecified Form What 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.

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR WATER)
GREEN (C48329)

NDC Code Structure

  • 76357 - Triumph Pharmaceuticals Inc.

NDC 76357-409-16

Package Description: 1 KIT in 1 CELLO PACK * 237 mL in 1 BOTTLE, PLASTIC * 237 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Smartmouth Mouth Sore Zinc Activated Formula with NDC 76357-409 is a a human over the counter drug product labeled by Triumph Pharmaceuticals Inc.. The generic name of Smartmouth Mouth Sore Zinc Activated Formula is menthol, unspecified form. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2108024.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What 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.

Inactive Ingredient(s)

About 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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLOXAMER 124 (UNII: 1S66E28KXA)
  • ZINC CHLORIDE (UNII: 86Q357L16B)
  • SODIUM (UNII: 9NEZ333N27)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SORBITOL (UNII: 506T60A25R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Triumph Pharmaceuticals Inc.
Labeler Code: 76357
FDA Application Number: part356 What 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. What 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: 01-01-2022 What 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: 12-31-2022 What 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 - NO What 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Smartmouth Mouth Sore Zinc Activated Formula 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

DISTRIBUTED BY:TRIUMPH PHARMACEUTICALS INC.ST. LOUIS, MISSOURI 63141

Active Ingredient

Menthol 0.2% (when mixed as directed)

Purpose

Oral Pain Reliever

Uses

  • For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.For the temporary relief of pain associated with:Canker soresMinor dental proceduresMinor irritation or injury of the mouth or gumsMinor irritation of the mouth and gums caused by dentures or orthodontic appliances

Otc - Do Not Use

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

Otc - When Using

  • When using this product do not swallowdo not exceed recommended dosage

Stop Use And See Your Physician Promptly If

  • Swelling, rash or fever developsirritation, pain or redness persists or worsenssore mouth symptoms do not improve in 7 days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Adults and children 12 years of age & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.Children 6 years to under 12 years of age should be supervised in the use of this product.Children under 6 years of age: do not use.

Inactive Ingredients

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Sorbitol, Poloxamer 407, Glycerin, Propylene Glycol, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Peppermint Oil, Benzoic Acid, Aloe Extract, Sodium Chloride, D&C Yellow No. 10, FD&C Blue No. 1

Questions?

1-800-492-7040

* Please review the disclaimer below.