Ortho Guard Gel, Dentifrice
NDC Package 63783-403-16

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

Package Information

Ortho Guard (sodium fluoride) gel is aDULTS AND CHILDREN 6 YEARS AND OLDERUSE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING. This formulation utilizes a gel, dentifrice delivery system. Marketed by Massco Dental A Division Of Dunagin Pharmaceuticals, this product is identified by NDC 63783-403 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
63783-403-16
Package Description
473 mL in 1 BOTTLE
Product Code
63783-403
11-Digit Billing Format
63783040316

Clinical Specifications

Proprietary Name
Ortho Guard
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE 4.4 mg/10mL
Usage Information
ADULTS AND CHILDREN 6 YEARS AND OLDERUSE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING. CHILDREN UNDER 6CONSULT A DENTIST OR PHYSICIAN

Regulatory & Marketing

Labeler Name
Massco Dental A Division Of Dunagin Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
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 63783-403-16 identifies a specific commercial package of 473 ml in 1 bottle of Ortho Guard, a human over the counter drug labeled by Massco Dental A Division Of Dunagin Pharmaceuticals. This gel, dentifrice 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: 63783040316. 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)
63783-403-16
11-Digit CMS (5-4-2)
63783-0403-16

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