Neutra Maxx 5000 Gel
NDC Package 63783-504-06

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

Package Information

Neutra Maxx 5000 (sodium fluoride) gel is dIRECTIONS:  (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)   ADULTS AND CHILDREN 6 YEARS AND OLDER:  USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE.  AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE.  BEFORE BEDTIME IS BEST.  ADULTS SHOULD EXPECTORATE AFTER USE.  CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE. This formulation utilizes a gel delivery system. Marketed by Massco Dental A Division Of Dunagin Pharmaceuticals, this product is identified by NDC 63783-504.

Identification & Billing

NDC Package Code
63783-504-06
Package Description
120 g in 1 BOTTLE, DISPENSING
Product Code
63783-504
11-Digit Billing Format
63783050406
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Neutra Maxx 5000
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE 1.428 g/120g
Usage Information
DIRECTIONS:  (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)   ADULTS AND CHILDREN 6 YEARS AND OLDER:  USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE.  AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE.  BEFORE BEDTIME IS BEST.  ADULTS SHOULD EXPECTORATE AFTER USE.  CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

Regulatory & Marketing

Labeler Name
Massco Dental A Division Of Dunagin Pharmaceuticals
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
01-01-1989
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 63783-504-06 identifies a specific commercial package of 120 g in 1 bottle, dispensing of Neutra Maxx 5000, a human prescription drug labeled by Massco Dental A Division Of Dunagin Pharmaceuticals. This gel 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 Massco Dental A Division Of Dunagin Pharmaceuticals on January 01, 1989. The current certification is valid through December 31, 2026.

How is this Massco Dental A Division Of Dunagin Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63783050406. 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)
63783-504-06
11-Digit CMS (5-4-2)
63783-0504-06

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