Kolmed Hand Sanitizing Wipes
NDC Package 75670-008-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Kolmed Hand Sanitizing Wipes is • wet hands thoroughly with product and allow to dry without wiping• supervise children under 6 years of age when using this product to avoid swallowing• discard wipe in trash after use. Marketed by Shanghai Sanjun General Merchandise Co., Ltd., this product is identified by NDC 75670-008 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
75670-008-01
Package Description
85 PACKAGE in 1 CANISTER / 4.41 g in 1 PACKAGE
Product Code
75670-008
11-Digit Billing Format
75670000801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kolmed Hand Sanitizing Wipes
Dosage Form
-
Usage Information
• wet hands thoroughly with product and allow to dry without wiping• supervise children under 6 years of age when using this product to avoid swallowing• discard wipe in trash after use. Do not flush

Regulatory & Marketing

Labeler Name
Shanghai Sanjun General Merchandise Co., Ltd.
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-17-2020
Listing Expiration
12-31-2021
Exclude Flag
I
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 (75670-008). Click a package code to view its specific billing and regulatory data.

75670-008-02
4 CANISTER in 1 BOX / 85 PACKAGE in 1 CANISTER / 4.41 g in 1 PACKAGE

* 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 75670-008-01 identifies a specific commercial package of 85 package in 1 canister / 4.41 g in 1 package of Kolmed Hand Sanitizing Wipes, labeled by Shanghai Sanjun General Merchandise Co., Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Shanghai Sanjun General Merchandise Co., Ltd. on August 17, 2020. The current certification is valid through December 31, 2021.

How is this Shanghai Sanjun General Merchandise Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75670000801. 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)
75670-008-01
11-Digit CMS (5-4-2)
75670-0008-01

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