Western Family Sensitive Whitening Fluoride
NDC Package 55312-158-09

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.

Western Family Sensitive Whitening Fluoride is adults and children          Brush teeth for at least one minute, preferably after 12 years and older           each meal, or at least twice a day, or as directed by your dentist.                                            Be sure to brush sensitive areas.Children under                 Consult a dentist or doctor.12 years of ageOther information            Store in a cool, dry place. Marketed by Western Family Food, Inc., this product is identified by NDC 55312-158 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
55312-158-09
Package Description
113 g in 1 TUBE
Product Code
55312-158
11-Digit Billing Format
55312015809
RxNorm Crosswalk
  • RxCUI: 1038800 - potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) Toothpaste
  • RxCUI: 1038800 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 1038800 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 1038800 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 1038800 - potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Western Family Sensitive Whitening Fluoride
Dosage Form
-
Usage Information
Adults and children          Brush teeth for at least one minute, preferably after 12 years and older           each meal, or at least twice a day, or as directed by your dentist.                                            Be sure to brush sensitive areas.Children under                 Consult a dentist or doctor.12 years of ageOther information            Store in a cool, dry place.

Regulatory & Marketing

Labeler Name
Western Family Food, Inc.
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
05-02-2007
Listing Expiration
12-31-2017
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 55312-158-09 identifies a specific commercial package of 113 g in 1 tube of Western Family Sensitive Whitening Fluoride, labeled by Western Family Food, Inc.. 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 Western Family Food, Inc. on May 02, 2007. The current certification is valid through December 31, 2017.

How is this Western Family Food, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55312015809. 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)
55312-158-09
11-Digit CMS (5-4-2)
55312-0158-09

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