Walgreens Maximum Strength Sensitive Fluoride
NDC Package 0363-0631-09

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.

Walgreens Maximum Strength Sensitive 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. Marketed by Walgreens, this product is identified by NDC 0363-0631 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
0363-0631-09
Package Description
113 g in 1 TUBE
Product Code
0363-0631
11-Digit Billing Format
00363063109
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
Walgreens Maximum Strength Sensitive 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 age             Other information        Store in a cool, dry place.

Regulatory & Marketing

Labeler Name
Walgreens
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
06-06-2006
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 0363-0631-09 identifies a specific commercial package of 113 g in 1 tube of Walgreens Maximum Strength Sensitive Fluoride, labeled by Walgreens. 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 Walgreens on June 06, 2006. The current certification is valid through December 31, 2017.

How is this Walgreens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363063109. 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)
0363-0631-09
11-Digit CMS (5-4-2)
00363-0631-09

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