Chewpaste With Fluoride
NDC Package 81048-008-92

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Chewpaste With Fluoride is adults and children over 6 years of age: 1 tablet, 2 times per day • Do not swallow • Pop 1 tablet in your mouth and chew, wet your toothbrush and brush normally • Repeat every morning and night • Consult a healthcare professional before using on children under 6 years. Marketed by 2557807 Ontario Inc, this product is identified by NDC 81048-008 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
81048-008-92
Package Description
192 TABLET, CHEWABLE in 1 JAR
Product Code
81048-008
11-Digit Billing Format
81048000892

Clinical Specifications

Proprietary Name
Chewpaste With Fluoride
Dosage Form
-
Usage Information
Adults and children over 6 years of age: 1 tablet, 2 times per day • Do not swallow • Pop 1 tablet in your mouth and chew, wet your toothbrush and brush normally • Repeat every morning and night • Consult a healthcare professional before using on children under 6 years

Regulatory & Marketing

Labeler Name
2557807 Ontario Inc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-15-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81048-008). Click a package code to view its specific billing and regulatory data.

81048-008-64
64 TABLET, CHEWABLE in 1 JAR

* 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 81048-008-92 identifies a specific commercial package of 192 tablet, chewable in 1 jar of Chewpaste With Fluoride, labeled by 2557807 Ontario 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 2557807 Ontario Inc on February 15, 2021. The current certification is valid through December 31, 2021.

How is this 2557807 Ontario Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81048000892. 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)
81048-008-92
11-Digit CMS (5-4-2)
81048-0008-92

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