Oral-b
NDC Package 0041-1421-16

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.

Oral-b is adults and children 6 years and older: use once a day after brushing your teeth with toothpaste.Vigorously swish 10ml (as indicated inside cap) of rinse between your teeth for 1 minute then spit out. Marketed by Oral-b Laboratories, this product is identified by NDC 0041-1421 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
0041-1421-16
Package Description
500 mL in 1 BOTTLE, PLASTIC
Product Code
0041-1421
11-Digit Billing Format
00041142116
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oral-b Anticavity
Dosage Form
-
Usage Information
Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste.Vigorously swish 10ml (as indicated inside cap) of rinse between your teeth for 1 minute then spit out. Do not swallow.Do not eat or drink for 30 minutes after rinsing.Instruct children under 12 years of age in good rinsing habits to minimize swallowing.Supervise children as necessary until capable of using without supervision.Consult a dentist or physician for use by children under 6 years of age.

Regulatory & Marketing

Labeler Name
Oral-b Laboratories
FDA Application #
part355
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
10-15-2005
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 0041-1421-16 identifies a specific commercial package of 500 ml in 1 bottle, plastic of Oral-b Anticavity, labeled by Oral-b Laboratories. 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 Oral-b Laboratories on October 15, 2005. The current certification is valid through December 31, 2017.

How is this Oral-b Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00041142116. 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)
0041-1421-16
11-Digit CMS (5-4-2)
00041-1421-16

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