Therabreath Healthy Smile Oral Rinse
NDC Package 72551-246-01

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.

Therabreath Healthy Smile Oral Rinse is adults and Children 6 years of age and older:Use once a day after brushing your teeth with a toothpaste.Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.Do not swallow the rinse.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.Children under 6 years of age: consult a dentist or doctor. Marketed by Dr. Harold Katz, Llc, this product is identified by NDC 72551-246 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
72551-246-01
Package Description
473 g in 1 BOTTLE, PLASTIC
Product Code
72551-246
11-Digit Billing Format
72551024601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Therabreath Healthy Smile Oral Rinse
Dosage Form
-
Usage Information
Adults and Children 6 years of age and older:Use once a day after brushing your teeth with a toothpaste.Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.Do not swallow the rinse.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.Children under 6 years of age: consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Dr. Harold Katz, Llc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-02-2018
Listing Expiration
12-31-2023
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 (72551-246). Click a package code to view its specific billing and regulatory data.

72551-246-02
85 g in 1 BOTTLE, PLASTIC
72551-246-03
7 g in 1 POUCH
72551-246-04
958.21 g in 1 BOTTLE

* 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 72551-246-01 identifies a specific commercial package of 473 g in 1 bottle, plastic of Therabreath Healthy Smile Oral Rinse, labeled by Dr. Harold Katz, Llc. 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 Dr. Harold Katz, Llc on October 02, 2018. The current certification is valid through December 31, 2023.

How is this Dr. Harold Katz, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72551024601. 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)
72551-246-01
11-Digit CMS (5-4-2)
72551-0246-01

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