Truwell Dentiwash
NDC Package 61284-0013-2

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.

Truwell Dentiwash is adults and children 6 years of age and older:use twoce a day after brishing your teeth with a toothpastevigorously swish contents of one (1) 11mL packet between your teeth for 1 minute and then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervisionChildren uder 6 years of age: consult a dentist or doctor. Marketed by Ecoworldpharm Co.,ltd, this product is identified by NDC 61284-0013 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
61284-0013-2
Package Description
250 PACKAGE in 1 PACKAGE / 11 mL in 1 PACKAGE (61284-0013-1)
Product Code
61284-0013
11-Digit Billing Format
61284001302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Truwell Dentiwash
Dosage Form
-
Usage Information
Adults and children 6 years of age and older:use twoce a day after brishing your teeth with a toothpastevigorously swish contents of one (1) 11mL packet between your teeth for 1 minute and then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervisionChildren uder 6 years of age: consult a dentist or doctor

Regulatory & Marketing

Labeler Name
Ecoworldpharm Co.,ltd
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-05-2023
Listing Expiration
12-31-2024
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 61284-0013-2 identifies a specific commercial package of 250 package in 1 package / 11 ml in 1 package (61284-0013-1) of Truwell Dentiwash, labeled by Ecoworldpharm Co.,ltd. 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 Ecoworldpharm Co.,ltd on October 05, 2023. The current certification is valid through December 31, 2024.

How is this Ecoworldpharm Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61284001302. 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 (5-4-1)
61284-0013-2
11-Digit CMS (5-4-2)
61284-0013-02

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