Pro-den Rx Rinse
NDC Package 59883-720-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pro-den Rx (stannous fluoride) rinses is 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. This formulation utilizes a rinse delivery system. Marketed by Den-mat Holdings, Llc, this product is identified by NDC 59883-720 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
59883-720-08
Package Description
1 BOTTLE in 1 CARTON / 283.5 g in 1 BOTTLE
Product Code
59883-720
11-Digit Billing Format
59883072008

Clinical Specifications

Proprietary Name
Pro-den Rx
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous Fluoride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
STANNOUS FLUORIDE 1.53 mg/g
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

Regulatory & Marketing

Labeler Name
Den-mat Holdings, Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-31-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59883-720-08 identifies a specific commercial 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. This rinse is formulated for oral use and contains stannous fluoride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Den-mat Holdings, Llc on October 31, 2008. The current certification is valid through December 31, 2026.

How is this Den-mat Holdings, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59883072008. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59883-720-08
11-Digit CMS (5-4-2)
59883-0720-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.