Beanguard Sensitivetoothpaste
NDC Package 77935-401-01

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.

Beanguard Sensitivetoothpaste is ■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).Supervise children as necessary until capable of using without supervision. Marketed by Bio3s Co.,ltd., this product is identified by NDC 77935-401 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
77935-401-01
Package Description
120 mL in 1 TUBE
Product Code
77935-401
11-Digit Billing Format
77935040101

Clinical Specifications

Proprietary Name
Beanguard Sensitivetoothpaste
Dosage Form
-
Usage Information
■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Bio3s Co.,ltd.
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
12-27-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 77935-401-01 identifies a specific commercial package of 120 ml in 1 tube of Beanguard Sensitivetoothpaste, labeled by Bio3s 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 Bio3s Co.,ltd. on December 27, 2022. The current certification is valid through December 31, 2023.

How is this Bio3s Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77935040101. 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)
77935-401-01
11-Digit CMS (5-4-2)
77935-0401-01

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