Fluoridex Liquid
NDC Package 59883-004-01

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

Package Information

Fluoridex (stannous fluoride rinse) liquids is adults and children 6 years of age and older:Do not use before mixing with waterUse once a day after brushing your teeth with toothpasteSeparate provided graduated cup from the mixing capLift spout and fill graduated cup to 1/8oz. This formulation utilizes a liquid delivery system. Marketed by Den-mat Holdings, Llc, this product is identified by NDC 59883-004 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
59883-004-01
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 310 g in 1 BOTTLE, PLASTIC
Product Code
59883-004
11-Digit Billing Format
59883000401

Clinical Specifications

Proprietary Name
Fluoridex
Non-Proprietary Name
Stannous Fluoride Rinse
Substance Name
Stannous Fluoride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
STANNOUS FLUORIDE 1.53 mg/g
Usage Information
Adults and children 6 years of age and older:Do not use before mixing with waterUse once a day after brushing your teeth with toothpasteSeparate provided graduated cup from the mixing capLift spout and fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse ConcentrateAdd warm water to 1 oz. fill linePlace the mixing cap onto the filled cap until it snaps closedShake thoroughly then remove mixing capUse immediately after preparing the rinseVigorously swish with half of the prepared solution between your teeth for 1 minute and then spit outDo not swallow the rinseRepeat the procedure with the remaining half of the prepared solutionDo not eat or drink for 30 minutes after rinisingInstruct children under 12 years of age in good rinsing habits (to minimize swallowing)Supervise children as necessary until capable of using without supervisionChildren under 6 years of ageConsult a dentist or doctor

Regulatory & Marketing

Labeler Name
Den-mat Holdings, Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-11-2016
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 59883-004-01 identifies a specific commercial package of 1 bottle, plastic in 1 box / 310 g in 1 bottle, plastic of Fluoridex, a human over the counter drug labeled by Den-mat Holdings, Llc. This liquid 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 January 11, 2016. 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: 59883000401. 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)
59883-004-01
11-Digit CMS (5-4-2)
59883-0004-01

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