NDC 69842-645 Gum And Enamel Repair

Stannous Fluoride

NDC Product Code 69842-645

NDC CODE: 69842-645

Proprietary Name: Gum And Enamel Repair 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: Stannous Fluoride 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)
Flavor(s):
MINT (C73404)

NDC Code Structure

  • 69842 - Cvs

NDC 69842-645-59

Package Description: 1 TUBE in 1 CARTON > 116.2 g in 1 TUBE

NDC Product Information

Gum And Enamel Repair with NDC 69842-645 is a a human over the counter drug product labeled by Cvs. The generic name of Gum And Enamel Repair is stannous fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Gum And Enamel Repair Active Ingredient(s)

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


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)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ZINC CITRATE (UNII: K72I3DEX9B)
  • SACCHARIN (UNII: FST467XS7D)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Cvs
Labeler Code: 69842
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: 10-18-2021 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".

* Please review the disclaimer below.

Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

* Please review the disclaimer below.

Gum And Enamel Repair Product Label Images

Gum And Enamel Repair 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

Otc - Active Ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Otc - Purpose

Anticavity/antigingivitis

Indications & Usage

Aids in the prevention of cavities * helps prevent gingivitis * helps interferre with the harmful effects of plaque associated with gingivisits * helps control plaque bacteria that contribute to the development of gingivitis

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician * do not swallow * children under 12 years of age: ask a dentist

Other Safety Information

Products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing my prevent these stains which are not harmful or permanent and may be removed by your dentist * this product is specifically formulated to help prevent staining * see your dentist regularly

Inactive Ingredient

Water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

* Please review the disclaimer below.