NDC Package 61284-0011-2 Truwell Kids Dentiwash

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61284-0011-2
Package Description:
30 PACKAGE in 1 PACKAGE / 11 mL in 1 PACKAGE (61284-0011-1)
Product Code:
Proprietary Name:
Truwell Kids Dentiwash
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
11-Digit NDC Billing Format:
61284001102
NDC to RxNorm Crosswalk:
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse
  • RxCUI: 313029 - sodium fluoride 0.2 MG/ML Mouthwash
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse
Labeler Name:
Ecoworldpharm Co.,ltd
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
10-05-2023
Listing Expiration Date:
12-31-2024
Exclude Flag:
I
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 61284-0011-2?

The NDC Packaged Code 61284-0011-2 is assigned to a package of 30 package in 1 package / 11 ml in 1 package (61284-0011-1) of Truwell Kids Dentiwash, labeled by Ecoworldpharm Co.,ltd. The product's dosage form is and is administered via form.

Is NDC 61284-0011 included in the NDC Directory?

No, Truwell Kids Dentiwash with product code 61284-0011 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Ecoworldpharm Co.,ltd on October 05, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61284-0011-2?

The 11-digit format is 61284001102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-161284-0011-25-4-261284-0011-02