Antiseptic Wipe Cloth
NDC Package 83165-002-00

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

Package Information

Antiseptic Wipe (benzalkonium chloride) cloths is tear open packet, unfold towelette Tand use to cleanse desired skin area. This formulation utilizes a cloth delivery system. Marketed by Hubei Fanjian Medical Product Co.,ltd, this product is identified by NDC 83165-002 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
83165-002-00
Package Description
.62 mL in 1 PATCH
Product Code
83165-002
11-Digit Billing Format
83165000200
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Antiseptic Wipe
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 open packet, unfold towelette Tand use to cleanse desired skin area. Discard towelette appropriately after single use. 

Regulatory & Marketing

Labeler Name
Hubei Fanjian Medical Product Co.,ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-14-2023
Listing Expiration
12-31-2027
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 83165-002-00 identifies a specific commercial package of .62 ml in 1 patch of Antiseptic Wipe, a human over the counter drug labeled by Hubei Fanjian Medical Product Co.,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 Hubei Fanjian Medical Product Co.,ltd on January 14, 2023. The current certification is valid through December 31, 2027.

How is this Hubei Fanjian Medical Product Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83165000200. 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)
83165-002-00
11-Digit CMS (5-4-2)
83165-0002-00

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