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  5. NDC Package Code: 59883-720-08 Pro-den Rx

NDC Package 59883-720-08 Pro-den Rx

Stannous Fluoride Rinse 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:
59883-720-08
Package Description:
1 BOTTLE in 1 CARTON / 283.5 g in 1 BOTTLE
Product Code:
59883-720
Proprietary Name:
Pro-den Rx
Non-Proprietary Name:
Stannous Fluoride
Substance Name:
Stannous Fluoride
Usage Information:
Do not use before mixing with water Use immediately after preparing the rinse Adults and children 6 years of age and older:Use as directed by a dental professional Use once a day after brushing your teeth with a toothpaste or as directed by your dentist Remove cap and seal and replace with pump Rotate spout counter clockwise to extend Depress pump until medicine comes to the tip of the pump Put 1/8 oz. (approx. 2 pump strokes) of concentrated Pro-DenRx Rinse into the provided mixing vial Add water to 1 oz. line on mixing vial Tightly snap on the cap and shake well Vigorously swish between your teeth 1/2 of mixture for one minute and then spit out Repeat procedure with remaining mixture Rinse mixing vial with water after use Do not swallow the rinse Do not eat or drink for 30 minutes after rinsing Children 6 to 12 years of age:Instruct children 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 For home irrigation Prepare 1 oz. of Pro-DenRx Rinse as described above Pour into irrigator reservoir, add 4 oz. of water and mix thoroughly Use irrigator as directed Rinse irrigator with water after use
11-Digit NDC Billing Format:
59883072008
Product Type:
Human Otc Drug
Labeler Name:
Den-mat Holdings, Llc
Dosage Form:
Rinse - A liquid used to cleanse by flushing.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • STANNOUS FLUORIDE 1.53 mg/g
    • Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-31-2008
    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 59883-720-08?

    The NDC Packaged Code 59883-720-08 is assigned to a package of 1 bottle in 1 carton / 283.5 g in 1 bottle of Pro-den Rx, a human over the counter drug labeled by Den-mat Holdings, Llc. The product's dosage form is rinse and is administered via oral form.

    Is NDC 59883-720 included in the NDC Directory?

    Yes, Pro-den Rx with product code 59883-720 is active and included in the NDC Directory. The product was first marketed by Den-mat Holdings, Llc on October 31, 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 59883-720-08?

    The 11-digit format is 59883072008. 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
    5-3-259883-720-085-4-259883-0720-08