Jianyi Hand Sanitizer Gel
NDC Package 54380-003-01

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.

Jianyi Hand Sanitizer Gel is skin disinfection: Apply this product evenly on the skin surface for 1 minute. Marketed by L&p Food Ingredient Co., Ltd., this product is identified by NDC 54380-003 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
54380-003-01
Package Description
300 mL in 1 BOTTLE
Product Code
54380-003
11-Digit Billing Format
54380000301

Clinical Specifications

Proprietary Name
Jianyi Hand Sanitizer Gel
Dosage Form
-
Usage Information
Skin disinfection: Apply this product evenly on the skin surface for 1 minute. Hand disinfection: Take an appropriate amount of disinfection gel on the paim of your hand and rub your hands together to evenly distrbute the disinfection gel for one minute.

Regulatory & Marketing

Labeler Name
L&p Food Ingredient Co., Ltd.
FDA Application #
part333E
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
04-23-2020
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 54380-003-01 identifies a specific commercial package of 300 ml in 1 bottle of Jianyi Hand Sanitizer Gel, labeled by L&p Food Ingredient 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 L&p Food Ingredient Co., Ltd. on April 23, 2020. The current certification is valid through December 31, 2021.

How is this L&p Food Ingredient Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54380000301. 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)
54380-003-01
11-Digit CMS (5-4-2)
54380-0003-01

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