Gel 7 Neutral Topical Fluoride Gel Mint
NDC Package 61508-0176-1

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.

Gel 7 Neutral Topical Fluoride Gel Mint is 1. Marketed by Germiphene Corporation, this product is identified by NDC 61508-0176.

Identification & Billing

NDC Package Code
61508-0176-1
Package Description
450 g in 1 BOTTLE, PLASTIC
Product Code
61508-0176
11-Digit Billing Format
61508017601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gel 7 Neutral Topical Fluoride Gel Mint
Dosage Form
-
Usage Information
1. Shake well before using. 2. Fill Germiphene brand disposable gel trays to appropriate level. 3. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 4. Remove trays and have patient expectorate excess gel.

Regulatory & Marketing

Labeler Name
Germiphene Corporation
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-03-2017
Listing Expiration
12-31-2018
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 61508-0176-1 identifies a specific commercial package of 450 g in 1 bottle, plastic of Gel 7 Neutral Topical Fluoride Gel Mint, labeled by Germiphene Corporation. 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 Germiphene Corporation on February 03, 2017. The current certification is valid through December 31, 2018.

How is this Germiphene Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61508017601. 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 (5-4-1)
61508-0176-1
11-Digit CMS (5-4-2)
61508-0176-01

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