Fluoride Gel
NDC Package 71035-400-01

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

Package Information

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

Fluoride Gel is adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)Children under 2 years:Ask a dentist or a physician. Marketed by Yangzhou Hongshengding Chemical Co.,ltd., this product is identified by NDC 71035-400 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
71035-400-01
Package Description
720 TUBE in 1 BOX / 17 g in 1 TUBE
Product Code
71035-400
11-Digit Billing Format
71035040001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoride Gel
Dosage Form
-
Usage Information
Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)Children under 2 years:Ask a dentist or a physician.

Regulatory & Marketing

Labeler Name
Yangzhou Hongshengding Chemical Co.,ltd.
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
05-01-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71035-400). Click a package code to view its specific billing and regulatory data.

71035-400-02
720 TUBE in 1 BOX / 24 g in 1 TUBE
71035-400-03
144 TUBE in 1 BOX / 43 g in 1 TUBE
71035-400-04
1000 TUBE in 1 BOX / .22 g in 1 TUBE
71035-400-05
1000 TUBE in 1 BOX / 7 g in 1 TUBE

* 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 71035-400-01 identifies a specific commercial package of 720 tube in 1 box / 17 g in 1 tube of Fluoride Gel, labeled by Yangzhou Hongshengding Chemical Co.,ltd.. 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 Yangzhou Hongshengding Chemical Co.,ltd. on May 01, 2015. The current certification is valid through December 31, 2019.

How is this Yangzhou Hongshengding Chemical Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71035040001. 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)
71035-400-01
11-Digit CMS (5-4-2)
71035-0400-01

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