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  5. NDC Package Code: 59883-004-01 Fluoridex

NDC Package 59883-004-01 Fluoridex

Stannous Fluoride Rinse Liquid 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:
59883-004-01
Package Description:
1 BOTTLE, PLASTIC in 1 BOX / 310 g in 1 BOTTLE, PLASTIC
Product Code:
59883-004
Proprietary Name:
Fluoridex
Non-Proprietary Name:
Stannous Fluoride Rinse
Substance Name:
Stannous Fluoride
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
11-Digit NDC Billing Format:
59883000401
Product Type:
Human Otc Drug
Labeler Name:
Den-mat Holdings, Llc
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(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:
01-11-2016
Listing Expiration Date:
12-31-2025
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 59883-004-01?

The NDC Packaged Code 59883-004-01 is assigned to a 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. The product's dosage form is liquid and is administered via oral form.

Is NDC 59883-004 included in the NDC Directory?

Yes, Fluoridex with product code 59883-004 is active and included in the NDC Directory. The product was first marketed by Den-mat Holdings, Llc on January 11, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 59883-004-01?

The 11-digit format is 59883000401. 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
5-3-259883-004-015-4-259883-0004-01