Truguard 5000 Paste, Dentifrice
NDC Package 71347-500-04

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

Package Information

Truguard 5000 (sodium fluoride toothpaste) pastes is iNDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. This formulation utilizes a paste, dentifrice delivery system. Marketed by The Atlanta Dental Supply Company Dba Advanced Dental Products, this product is identified by NDC 71347-500.

Identification & Billing

NDC Package Code
71347-500-04
Package Description
1 TUBE in 1 BOX / 112 g in 1 TUBE
Product Code
71347-500
11-Digit Billing Format
71347050004

Clinical Specifications

Proprietary Name
Truguard 5000
Non-Proprietary Name
Sodium Fluoride Toothpaste
Substance Name
Potassium Nitrate; Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 TruGuard brand of 1.1% sodium fluoride in a squeeze tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Regulatory & Marketing

Labeler Name
The Atlanta Dental Supply Company Dba Advanced Dental Products
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
03-16-2023
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 71347-500-04 identifies a specific commercial package of 1 tube in 1 box / 112 g in 1 tube of Truguard 5000, a human prescription drug labeled by The Atlanta Dental Supply Company Dba Advanced Dental Products. This paste, dentifrice is formulated for oral use and contains potassium nitrate; 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 The Atlanta Dental Supply Company Dba Advanced Dental Products on March 16, 2023. The current certification is valid through December 31, 2026.

How is this The Atlanta Dental Supply Company Dba Advanced Dental Products product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71347050004. 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)
71347-500-04
11-Digit CMS (5-4-2)
71347-0500-04

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