Ology Fluoride
NDC Package 0363-2008-01

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.

Ology Fluoride is adults and children 12 years and older: brush teeth thoroughly, preferably after each meal, or at least twice a day, or as directed by your dentist.  do not swallow.children under 6 years of age: to minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.children under 2 years of age: ask a dentist or physician. Marketed by Walgreens, this product is identified by NDC 0363-2008 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
0363-2008-01
Package Description
133 g in 1 TUBE
Product Code
0363-2008
11-Digit Billing Format
00363200801
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Ology Fluoride
Dosage Form
-
Usage Information
Adults and children 12 years and older: brush teeth thoroughly, preferably after each meal, or at least twice a day, or as directed by your dentist.  do not swallow.children under 6 years of age: to minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.children under 2 years of age: ask a dentist or physician.

Regulatory & Marketing

Labeler Name
Walgreens
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-21-2013
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 0363-2008-01 identifies a specific commercial package of 133 g in 1 tube of Ology 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 March 21, 2013. 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: 00363200801. 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)
0363-2008-01
11-Digit CMS (5-4-2)
00363-2008-01

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