Cleansol Antibacterial Wet Wipes
NDC Package 78089-048-01

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.

Cleansol Antibacterial Wet Wipes is • Remove lid, open cap, thread wipe through slit and close lid.• Gently remove wipe, clean skin thoroughly, and allow hands to dry.• Do not flush, dispose in a waste basket, and close lid after use.• Store at room temperature and protect from sun exposure.• For children under 2 years old, ask a doctor before use. Marketed by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi, this product is identified by NDC 78089-048 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78089-048-01
Package Description
100 PACKAGE in 1 CANISTER / 3.24 g in 1 PACKAGE
Product Code
78089-048
11-Digit Billing Format
78089004801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cleansol Antibacterial Wet Wipes
Dosage Form
-
Usage Information
• Remove lid, open cap, thread wipe through slit and close lid.• Gently remove wipe, clean skin thoroughly, and allow hands to dry.• Do not flush, dispose in a waste basket, and close lid after use.• Store at room temperature and protect from sun exposure.• For children under 2 years old, ask a doctor before use.

Regulatory & Marketing

Labeler Name
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
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
09-16-2020
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 (78089-048). Click a package code to view its specific billing and regulatory data.

78089-048-02
100 PACKAGE in 1 PACKET / 3.24 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 78089-048-01 identifies a specific commercial package of 100 package in 1 canister / 3.24 g in 1 package of Cleansol Antibacterial Wet Wipes, labeled by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi. 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 Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi on September 16, 2020. The current certification is valid through December 31, 2021.

How is this Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78089004801. 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)
78089-048-01
11-Digit CMS (5-4-2)
78089-0048-01

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