Pro-den Rx Rinse
NDC Package 59883-920-16

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 (sodium fluoride) rinses is aids in the prevention of dental caries. This formulation utilizes a rinse delivery system. Marketed by Den-mat Holdings, Llc, this product is identified by NDC 59883-920.

Identification & Billing

NDC Package Code
59883-920-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
59883-920
11-Digit Billing Format
59883092016
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pro-den Rx
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium 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)
SODIUM FLUORIDE .9 mg/mL
Usage Information
Aids in the prevention of dental caries. May be used more than once a week if recommended by your dentist. Pro-DenRx® Rinse is ready to use, convenient and thus increases compliance. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental cares in adults and children. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.

Regulatory & Marketing

Labeler Name
Den-mat Holdings, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
10-21-2008
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 59883-920-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Pro-den Rx, a human prescription drug labeled by Den-mat Holdings, Llc. This rinse is formulated for oral use and contains sodium 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 21, 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: 59883092016. 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)
59883-920-16
11-Digit CMS (5-4-2)
59883-0920-16

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