Scotts Select Neutral Apf Fluoride
NDC Package 69638-157-16

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.

Scotts Select Neutral Apf Fluoride is shake well before use.This is a four minute fluoride gel for in-office patient use.For best results, use at least twice a year.After thorough prophylaxis, fill two single or one dual tray one third full with gel. Marketed by Scott's Dental Supply Llc, this product is identified by NDC 69638-157.

Identification & Billing

NDC Package Code
69638-157-16
Package Description
500 mL in 1 BOTTLE
Product Code
69638-157
11-Digit Billing Format
69638015716
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Scotts Select Neutral Apf Fluoride
Dosage Form
-
Usage Information
Shake well before use.This is a four minute fluoride gel for in-office patient use.For best results, use at least twice a year.After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.Instruct patient to bite down lightly but firmly for four minutes.Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Regulatory & Marketing

Labeler Name
Scott's Dental Supply 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
01-01-2013
Listing Expiration
12-31-2021
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 69638-157-16 identifies a specific commercial package of 500 ml in 1 bottle of Scotts Select Neutral Apf Fluoride, labeled by Scott's Dental Supply 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 Scott's Dental Supply Llc on January 01, 2013. The current certification is valid through December 31, 2021.

How is this Scott's Dental Supply Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69638015716. 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)
69638-157-16
11-Digit CMS (5-4-2)
69638-0157-16

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