Zylastxp Antiseptic Foaming Soap
NDC Package 57362-467-01

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

Package Information

Zylastxp Antiseptic Foaming (benzethonium chloride) soaps is wet hands and forearms. This formulation utilizes a soap delivery system. Marketed by Innovative Biodefense, this product is identified by NDC 57362-467 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
57362-467-01
Package Description
244 mL in 1 BOTTLE
Product Code
57362-467
11-Digit Billing Format
57362046701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zylastxp Antiseptic Foaming
Non-Proprietary Name
Benzethonium Chloride
Substance Name
Benzethonium Chloride
Dosage Form
Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.
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)
BENZETHONIUM CHLORIDE 2 mg/mL
Usage Information
Wet hands and forearms. Apply a palmful to hands and scrub hands and forearms thoroughly for 15 seconds or more. Rinse and repeat. Wet hands and forearms. Apply a palmful to hands and scrub hands and forearms thoroughly for 15 seconds or more. Rinse and repeat.

Regulatory & Marketing

Labeler Name
Innovative Biodefense
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-06-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57362-467). Click a package code to view its specific billing and regulatory data.

57362-467-02
1000 mL in 1 BOTTLE

* 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 57362-467-01 identifies a specific commercial package of 244 ml in 1 bottle of Zylastxp Antiseptic Foaming, a human over the counter drug labeled by Innovative Biodefense. This soap is formulated for topical use and contains benzethonium 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 Innovative Biodefense on April 06, 2015. The current certification is valid through December 31, 2026.

How is this Innovative Biodefense product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57362046701. 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)
57362-467-01
11-Digit CMS (5-4-2)
57362-0467-01

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