Ctx3 Rinse
NDC Package 61578-303-01

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.

Ctx3 Rinse is adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Marketed by Dental Alliance Holdings Llc, this product is identified by NDC 61578-303 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
61578-303-01
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
61578-303
11-Digit Billing Format
61578030301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ctx3 Rinse Grape
Dosage Form
-
Usage Information
Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, 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 physician. Store below 30 degrees C (86 degrees F). Do not freeze.

Regulatory & Marketing

Labeler Name
Dental Alliance Holdings 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
05-01-2012
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 (61578-303). Click a package code to view its specific billing and regulatory data.

61578-303-02
59 mL in 1 BOTTLE, PLASTIC

* 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 61578-303-01 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Ctx3 Rinse Grape, labeled by Dental Alliance Holdings 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 Dental Alliance Holdings Llc on May 01, 2012. The current certification is valid through December 31, 2023.

How is this Dental Alliance Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61578030301. 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)
61578-303-01
11-Digit CMS (5-4-2)
61578-0303-01

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