Pro-den Rx
Sodium Fluoride
Den-mat Holdings, Llc
Human Prescription Drug
NDC 59883-824Pro-den Rx also known as Sodium Fluoride is a human prescription drug labeled by 'Den-mat Holdings, Llc'. National Drug Code (NDC) number for Pro-den Rx is 59883-824. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Pro-den Rx drug includes Sodium Fluoride - 4.3 g/g . The currest status of Pro-den Rx drug is Active.
Drug Information:
| Drug NDC: | 59883-824 |
| 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: | Pro-den Rx |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Sodium Fluoride |
| 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: | Gel |
| 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: | SODIUM FLUORIDE - 4.3 g/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: | UNAPPROVED DRUG OTHER |
| 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: | 20 Jan, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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. |
| 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. |
| RxCUI: | 392038
1101883
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 8ZYQ1474W7
|
| 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 |
|---|
| 59883-824-02 | 1 TUBE in 1 CARTON (59883-824-02) / 56 g in 1 TUBE | 20 Jan, 2009 | 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. |
Product Elements:
Pro-den rx sodium fluoride sodium phosphate, monobasic, unspecified form phosphoric acid water sodium hydroxide sucralose sodium fluoride fluoride ion mint
Indications and Usage:
Indications and usage: a homecare, self-applied topical fluoride treatment. aids in the prevention of dental caries (decay).
Warnings:
Warnings: keep out of reach of children. children under 6 years old: the potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.
Dosage and Administration:
Dosage and administration: apply daily at bedtime, in place of your regular toothpaste or more often if your dentist recommends additional therapy based on your diagnosis. cover brush head with pro-denrx 1.1% neutral sodium fluoride gel and brush around all tooth surfaces and gum line for at least two minutes. spit out gel. adults: wait 30 minutes before rinsing mouth. children under 12: rinse mouth thoroughly immediately after use. when using a mouthpiece or applicator, cover the inner surface with gel. place applicator in mouth and bite down lightly for at least one minute. remove applicator and rinse mouth. clean applicator with cold water.
Contraindications:
Contraindications: do not use in children under 6 unless recommended by a dentist.
Overdosage:
Overdosage: swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful. store at room temperature
Description:
Description: a homecare, self-applied topical fluoride treatment containing 1.1% neutral sodium fluoride (5000 ppm f). daily use aids in the prevention of dental caries (decay).
Clinical Pharmacology:
Clinical pharmacology: applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution.
How Supplied:
How supplied: net wt. 2 oz. (56 g) tube in a box. cool mint: ndc 59883-824-02 reorder 1-800-433-6628 reorder number: 2240mtm 965918 manufactured for den-mat holdings, llc 1017 w. central ave., lompoc, ca 93436 ©2014 den-mat holdings, llc. all rights reserved.
Package Label Principal Display Panel:
Principal display panel - carton label ndc 59883-824-02 pro-denrx ® aqueous gel 1.1% neutral sodium fluoride cool mint flavor contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical aqueous gel net wt. 2oz. (56 g) dye-free gel figure
Principal display panel - tube label ndc 59883-824-02 1.1% neutral sodium fluoride pro-denrx ® aqueous gel cool mint flavor contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical aqueous gel net wt. 2oz. (56 g) dye-free gel figure