Fluoridex
Stannous Fluoride Rinse
Den-mat Holdings, Llc
Human Otc Drug
NDC 59883-004Fluoridex also known as Stannous Fluoride Rinse is a human otc drug labeled by 'Den-mat Holdings, Llc'. National Drug Code (NDC) number for Fluoridex is 59883-004. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Fluoridex drug includes Stannous Fluoride - 1.53 mg/g . The currest status of Fluoridex drug is Active.
Drug Information:
| Drug NDC: | 59883-004 |
| 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: | Fluoridex |
| 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 Rinse |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Den-mat Holdings, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 1.53 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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 Jan, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | DEN-MAT HOLDINGS, LLC
|
| 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 |
|---|
| 59883-004-01 | 1 BOTTLE, PLASTIC in 1 BOX (59883-004-01) / 310 g in 1 BOTTLE, PLASTIC | 11 Jan, 2016 | 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:
Purpose anticavity
Product Elements:
Fluoridex stannous fluoride rinse stannous fluoride fluoride ion glycerin hydrogenated starch hydrolysate
Indications and Usage:
Use aids in the prevention of dental cavities
Warnings:
Do not swallow the rinse
Dosage and Administration:
Directions adults and children 6 years of age and older: do not use before mixing with water use once a day after brushing your teeth with a toothpaste separate provided graduated cup from the mixing cap fill graduated cup to 1/8oz. fill line with fluoridex daily renewal oral rinse concentrate add warm water to 1 oz. fill line place the mixing cap onto the filled cap until it snaps closed shake thoroughly then remove mixing cap use immediately after preparing the rinse vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out do not swallow the rinse repeat the procedure with the remaining half of the prepared solution do not eat or drink for 30 minutes after rinising instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age consult a dentist or doctor
Package Label Principal Display Panel:
Ndc 59883-004-01 fluoridex daily renewal prescription-strength dental decay prevention oral rinse concentrate clean mint 0.63% stannous fluoride 8.4 fl. oz. (248 ml) rx only fluoridex_rinse_image.jpg
Further Questions:
Questions or comments? call: 1-800-752-2564