Jianerkang Wipes Cloth
NDC Package 34645-0004-1

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

Package Information

Jianerkang Wipes (alcohol) cloths is apply wipe thoroughly onto hands and allow to dry. This formulation utilizes a cloth delivery system. Marketed by Jianerkang Medical Co., Ltd, this product is identified by NDC 34645-0004 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
34645-0004-1
Package Description
50 POUCH in 1 BAG / 10.466 mL in 1 POUCH
Product Code
34645-0004
11-Digit Billing Format
34645000401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Jianerkang Wipes
Non-Proprietary Name
Alcohol
Substance Name
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)
ALCOHOL .75 mL/mL
Usage Information
Apply wipe thoroughly onto hands and allow to dry. No rinsing required.Discard after single use. Dispose if used wpes in trash receptacle. Don not flush.If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe, sanitize with a second wipe.When not in use, keep lid closed to prevent evaporation.

Regulatory & Marketing

Labeler Name
Jianerkang Medical Co., Ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2020
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 34645-0004-1 identifies a specific commercial package of 50 pouch in 1 bag / 10.466 ml in 1 pouch of Jianerkang Wipes, a human over the counter drug labeled by Jianerkang Medical Co., Ltd. This cloth is formulated for topical use and contains 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 Jianerkang Medical Co., Ltd on April 30, 2020. The current certification is valid through December 31, 2026.

How is this Jianerkang Medical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 34645000401. 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 (5-4-1)
34645-0004-1
11-Digit CMS (5-4-2)
34645-0004-01

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