Health E Alcohol-free Antiseptic Cloth
NDC Package 42326-090-01

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

Package Information

Health E Alcohol-free Antiseptic (benzalkonium chloride) cloths is tear V notch located on top of the plastic bag.Pull out the first wipe approximately 6 to 8 inches from the center of the roll.Place entire bag inside of center pull dispenser.Thread the wipe through the opening on the dispenser.Close the lid of the dispenser. This formulation utilizes a cloth delivery system. Marketed by Petra Hygienic Systems Int Ltd, this product is identified by NDC 42326-090 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
42326-090-01
Package Description
1000 PATCH in 1 BAG / 1.3 mL in 1 PATCH
Product Code
42326-090
11-Digit Billing Format
42326009001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Health E Alcohol-free Antiseptic
Non-Proprietary Name
Benzalkonium Chloride
Substance Name
Benzalkonium Chloride
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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 1.3 mg/mL
Usage Information
Tear V notch located on top of the plastic bag.Pull out the first wipe approximately 6 to 8 inches from the center of the roll.Place entire bag inside of center pull dispenser.Thread the wipe through the opening on the dispenser.Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.Apply topically to the skin to help prevent cross contamination.Recommended for repeated use.Dries in seconds.

Regulatory & Marketing

Labeler Name
Petra Hygienic Systems Int Ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-14-2020
End Marketing Date
01-31-2028
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 42326-090-01 identifies a specific commercial package of 1000 patch in 1 bag / 1.3 ml in 1 patch of Health E Alcohol-free Antiseptic, a human over the counter drug labeled by Petra Hygienic Systems Int Ltd. This cloth 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 Petra Hygienic Systems Int Ltd on April 14, 2020.

How is this Petra Hygienic Systems Int Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42326009001. 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)
42326-090-01
11-Digit CMS (5-4-2)
42326-0090-01

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