Pro-den Rx
Sodium Fluoride
Den-mat Holdings, Llc
Human Otc Drug
NDC 59883-821Pro-den Rx also known as Sodium Fluoride is a human otc drug labeled by 'Den-mat Holdings, Llc'. National Drug Code (NDC) number for Pro-den Rx is 59883-821. 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: | 59883-821 |
| 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 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: | 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: | 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: | 21 Nov, 2008 |
| 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. |
| 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 |
|---|
| 59883-821-02 | 1 TUBE in 1 CARTON (59883-821-02) / 56 g in 1 TUBE | 21 Nov, 2008 | 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:
Otc - purpose 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. indications and usage: it is well recognized that regular use of 1.1% neutral sodium fluoride (5000 ppm f) in mouthpiece applicators is safe and effective in preventing caries. 1-4 prodenrx brush-on gel may be applied using a toothbrush. plaque contributes to caries; therefore, reduction of plaque can help in preventing caries. contraindications: do not use in children under 6 unless recommended by a dentist. warnings: please 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. precautions: limited to topical use in mouth only. do not swallow. overdosage: swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful. dosage and administration: adults and children over 6 years of age: use in place of your regular toothpaste. apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. cover brush head with prodenrx 1.1% neutral sodium fluoride gel and brush around all tooth surfaces and gum line for at least 1 minute. spit out gel. adults: wait 30 minutes before rinsing mouth. for children under age 12: rinse mouth thoroughly immediately after use. store at room temperature how supplied: net wt. 2 oz. (56 g) tube in a box. cherry limeade: ndc 59883-821-02 references: 1. accepted dental therapeutics ed. 40 ada chicago, p. 405-407, 1984. 2. englander hr, et al.: jada 83:354-358 1971. 3. englander hr, et al.: jada 78:783-787 1969. 4. englander hr, et al.: jada 75:638-644 1967. rx only 1-800-228-5595 reorder number: 2250clm made for and distributed in us by: zila therapeutics, inc. p.o. box 3889, batesville, ar 72503
Product Elements:
Pro-den rx sodium fluoride diatomaceous earth glycerin carboxymethylcellulose phosphoric acid sodium benzoate saccharin sodium water sodium fluoride fluoride ion
Indications and Usage:
Indications & usage section indications and usage: it is well recognized that regular use of 1.1% neutral sodium fluoride (5000 ppm f) in mouthpiece applicators is safe and effective in preventing caries. 1-4 prodenrx brush-on gel may be applied using a toothbrush. plaque contributes to caries; therefore, reduction of plaque can help in preventing caries.
Warnings:
Warnings section warnings: please 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. precautions: limited to topical use in mouth only. do not swallow. overdosage: swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful.
Dosage and Administration:
Dosage & administration section dosage and administration: adults and children over 6 years of age: use in place of your regular toothpaste. apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. cover brush head with prodenrx 1.1% neutral sodium fluoride gel and brush around all tooth surfaces and gum line for at least 1 minute. spit out gel. adults: wait 30 minutes before rinsing mouth. for children under age 12: rinse mouth thoroughly immediately after use.
Package Label Principal Display Panel:
Package label.principal display panel 1e7e7d6a-figure-01 1e7e7d6a-figure-02