Toothy Oral Solution
NDC Package 54465-001-01

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.

Toothy Oral Solution is for external use only. Marketed by Shenzhen Roselle Bio-technology Holding Co.,ltd., this product is identified by NDC 54465-001.

Identification & Billing

NDC Package Code
54465-001-01
Package Description
15 L in 1 BOTTLE
Product Code
54465-001
11-Digit Billing Format
54465000101

Clinical Specifications

Proprietary Name
Toothy Oral Solution
Dosage Form
-
Usage Information
For external use only. Open the dust cover, tilt your head slightly backwards, rotate the nozzle to the front of the mouth,tap the manual pump, and spray the antibacterial solution into mouth. The recommended dosage is 4 sprays per use (3-4 times per day), however this product can be used more times per day depending on specific situations. Clean the nozzle and put the dust cover back on after each use.

Regulatory & Marketing

Labeler Name
Shenzhen Roselle Bio-technology Holding Co.,ltd.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-15-2020
Listing Expiration
12-31-2021
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 54465-001-01 identifies a specific commercial package of 15 l in 1 bottle of Toothy Oral Solution, labeled by Shenzhen Roselle Bio-technology Holding 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 Shenzhen Roselle Bio-technology Holding Co.,ltd. on April 15, 2020. The current certification is valid through December 31, 2021.

How is this Shenzhen Roselle Bio-technology Holding Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54465000101. 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)
54465-001-01
11-Digit CMS (5-4-2)
54465-0001-01

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