Club Wipes Usa Sanitizing Wipes Cloth
NDC Package 80976-102-01

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

Package Information

Club Wipes Usa Sanitizing Wipes (benzalkonium chloride) cloths is • Wet hands thoroughly with product and allow to dry.• Children under six years of age should be supervised when using this product. This formulation utilizes a cloth delivery system. Marketed by Bubble Marketing Llc, this product is identified by NDC 80976-102 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
80976-102-01
Package Description
1250 PACKAGE in 1 BAG / 3.15 mL in 1 PACKAGE
Product Code
80976-102
11-Digit Billing Format
80976010201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Club Wipes Usa Sanitizing Wipes
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 .13 g/100mL
Usage Information
• Wet hands thoroughly with product and allow to dry.• Children under six years of age should be supervised when using this product.

Regulatory & Marketing

Labeler Name
Bubble Marketing Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-30-2022
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 80976-102-01 identifies a specific commercial package of 1250 package in 1 bag / 3.15 ml in 1 package of Club Wipes Usa Sanitizing Wipes, a human over the counter drug labeled by Bubble Marketing Llc. 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 Bubble Marketing Llc on September 30, 2022. The current certification is valid through December 31, 2027.

How is this Bubble Marketing Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80976010201. 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)
80976-102-01
11-Digit CMS (5-4-2)
80976-0102-01

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