Rite Aid Gum And Enamel Repair
Stannous Fluoride
Rite Aid
Human Otc Drug
NDC 11822-5061Rite Aid Gum And Enamel Repair also known as Stannous Fluoride is a human otc drug labeled by 'Rite Aid'. National Drug Code (NDC) number for Rite Aid Gum And Enamel Repair is 11822-5061. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Rite Aid Gum And Enamel Repair drug includes Stannous Fluoride - .454 dL/100g . The currest status of Rite Aid Gum And Enamel Repair drug is Active.
Drug Information:
| Drug NDC: | 11822-5061 |
| 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: | Rite Aid Gum And Enamel Repair |
| 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: | Stannous Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rite Aid |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste, Dentifrice |
| 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: | STANNOUS FLUORIDE - .454 dL/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 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: | 11 Nov, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jun, 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: | part355 |
| 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, 2023 |
| 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: | Rite Aid
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3FTR44B32Q
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 11822-5061-9 | 1 TUBE in 1 BOX (11822-5061-9) / 116 g in 1 TUBE | 11 Nov, 2022 | N/A | 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. |
Purpose:
Products containing stannous fluoride may product surface staining of the teeth. adequate tooth brushing may prevent these stains whcih 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.
Product Elements:
Rite aid gum and enamel repair stannous fluoride stannous fluoride fluoride ion water sodium lauryl sulfate sodium hydroxide zinc citrate sucralose xanthan gum carrageenan titanium dioxide hydrated silica saccharin sodium sorbitol
Indications and Usage:
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.
Warnings:
Keep out of reach of children under 12 years of age. if more htan used for brushing is accidentally swallowd, get medical help or contact a poison control center right away.
Dosage and Administration:
Aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plauqe bacteria that contribute to the development of gingivitis.
Package Label Principal Display Panel:
5820061