Alcohol Prep Pads Cloth
NDC Package 85361-003-01

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

Package Information

Alcohol Prep Pads (wipes) cloths is indications for use:- For preparation of the skin prior to injection.- First aid to decrease germs in minor cuts, scrapes and burns. This formulation utilizes a cloth delivery system. Marketed by Shaoxing Keqiao Hunian Health Products Co.,ltd, this product is identified by NDC 85361-003 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
85361-003-01
Package Description
60 mL in 1 BAG
Product Code
85361-003
11-Digit Billing Format
85361000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alcohol Prep Pads
Non-Proprietary Name
Wipes
Substance Name
Isopropyl Alcohol
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)
ISOPROPYL ALCOHOL .7 mL/mL
Usage Information
Indications for use:- For preparation of the skin prior to injection.- First aid to decrease germs in minor cuts, scrapes and burns.

Regulatory & Marketing

Labeler Name
Shaoxing Keqiao Hunian Health Products Co.,ltd
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-15-2025
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 85361-003-01 identifies a specific commercial package of 60 ml in 1 bag of Alcohol Prep Pads, a human over the counter drug labeled by Shaoxing Keqiao Hunian Health Products Co.,ltd. This cloth is formulated for topical use and contains isopropyl alcohol 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 Shaoxing Keqiao Hunian Health Products Co.,ltd on March 15, 2025. The current certification is valid through December 31, 2026.

How is this Shaoxing Keqiao Hunian Health Products Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85361000301. 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)
85361-003-01
11-Digit CMS (5-4-2)
85361-0003-01

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