Fluorishield
NDC Package 0273-8011-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fluorishield is brush and floss your teeth to remove plaque. Marketed by Young Dental Manufacturing I, Llc, this product is identified by NDC 0273-8011.

Identification & Billing

NDC Package Code
0273-8011-01
Package Description
114 g in 1 TUBE
Product Code
0273-8011
11-Digit Billing Format
00273801101

Clinical Specifications

Proprietary Name
Fluorishield
Dosage Form
-
Usage Information
Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of FluoriShield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel. Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

Regulatory & Marketing

Labeler Name
Young Dental Manufacturing I, Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
09-21-2017
Listing Expiration
12-31-2019
Exclude Flag
I
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 0273-8011-01 identifies a specific commercial package of 114 g in 1 tube of Fluorishield, labeled by Young Dental Manufacturing I, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Young Dental Manufacturing I, Llc on September 21, 2017. The current certification is valid through December 31, 2019.

How is this Young Dental Manufacturing I, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00273801101. 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 (4-4-2)
0273-8011-01
11-Digit CMS (5-4-2)
00273-8011-01

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