Xtracare Foam Antibacterial Hand Wash Liquid
NDC Package 57337-045-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Xtracare Foam Antibacterial Hand Wash (benzalkonium chloride) liquids is xtraCare® Foam Antibacterial HAnd WashKills 99.9% of bacteriaRefillCompare to Lysol foam antibacterial hand washvanilla passion flower15 Fl Oz (444mL). This formulation utilizes a liquid delivery system. Marketed by Rejoice International, this product is identified by NDC 57337-045 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
57337-045-01
Package Description
444 g in 1 BOTTLE
Product Code
57337-045
11-Digit Billing Format
57337004501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower
Non-Proprietary Name
Benzalkonium Chloride
Substance Name
Benzalkonium Chloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
BENZALKONIUM CHLORIDE .5 g/444g
Usage Information
XtraCare® Foam Antibacterial HAnd WashKills 99.9% of bacteriaRefillCompare to Lysol foam antibacterial hand washvanilla passion flower15 Fl Oz (444mL)

Regulatory & Marketing

Labeler Name
Rejoice International
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-24-2014
Listing Expiration
12-31-2026
Exclude Flag
N
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 57337-045-01 identifies a specific commercial package of 444 g in 1 bottle of Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower, a human over the counter drug labeled by Rejoice International. This liquid is formulated for topical use and contains benzalkonium chloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Rejoice International on January 24, 2014. The current certification is valid through December 31, 2026.

How is this Rejoice International product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57337004501. 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)
57337-045-01
11-Digit CMS (5-4-2)
57337-0045-01

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