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  4. NDC Product Code: 59883-821 Pro-den Rx

NDC 59883-821 Pro-den Rx

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59883-821?
  5. Pro-den Rx Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 59883-821 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
59883-821
Proprietary Name:
Pro-den Rx
Product Type: [3]
Labeler Name: [5]
Den-mat Holdings, Llc
Labeler Code:
59883
Product Label ID:
bcda408e-4e54-4909-aae6-97b26b40830b
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
11-21-2008
End Marketing Date: [10]
11-22-2008
Listing Expiration Date: [11]
11-22-2008
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Flavor(s):
CHERRY (C73375)

Code Structure Chart

Product Details

What is NDC 59883-821?

The NDC code 59883-821 is assigned by the FDA to the product Pro-den Rx which is product labeled by Den-mat Holdings, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 59883-821-02 1 tube in 1 carton / 56 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Pro-den Rx?

This product is used as 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 TemperatureHow Supplied: Net Wt. 2 oz. (56 g) tube in a box.Cherry Limeade: NDC 59883-821-02References: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 Only1-800-228-5595REORDER NUMBER: 2250CLMMade for and Distributed in US by: Zila Therapeutics, Inc.P.O. Box 3889, Batesville, AR 72503

Which are Pro-den Rx UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Pro-den Rx Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

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Patient Education

Fluoride


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 usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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Product Footnotes

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

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - 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.

[11] 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.

[12] 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".