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  5. NDC Package Code: 59883-821-02 Pro-den Rx

NDC Package 59883-821-02 Pro-den Rx

Sodium Fluoride Gel Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
59883-821-02
Package Description:
1 TUBE in 1 CARTON / 56 g in 1 TUBE
Product Code:
59883-821
Proprietary Name:
Pro-den Rx
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
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
11-Digit NDC Billing Format:
59883082102
NDC to RxNorm Crosswalk:
  • RxCUI: 1101883 - Pro-Den RX 1.1 % Dental Gel
  • RxCUI: 1101883 - sodium fluoride 0.011 MG/MG Toothpaste [ProDenRx Gel]
  • RxCUI: 1101883 - Pro-Den Rx 1.1 % (fluoride ion 0.5 % ) Dental Gel
  • RxCUI: 1101883 - ProDenRx Gel 0.011 MG/MG Toothpaste
  • RxCUI: 392038 - sodium fluoride 1.1 % Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Den-mat Holdings, Llc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE 4.3 g/g
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    11-21-2008
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59883-821-02?

    The NDC Packaged Code 59883-821-02 is assigned to a package of 1 tube in 1 carton / 56 g in 1 tube of Pro-den Rx, a human over the counter drug labeled by Den-mat Holdings, Llc. The product's dosage form is gel and is administered via oral form.

    Is NDC 59883-821 included in the NDC Directory?

    Yes, Pro-den Rx with product code 59883-821 is active and included in the NDC Directory. The product was first marketed by Den-mat Holdings, Llc on November 21, 2008 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 59883-821-02?

    The 11-digit format is 59883082102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-259883-821-025-4-259883-0821-02