Suresafe Antibacterial Wipes
NDC Package 80671-003-80

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

Package Information

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

Suresafe Antibacterial Wipes is adults and Children over 2 years:Thoroughly clean hands or affected area and discard in waste. Marketed by Quanzhou Aiwina Hygiene Products Co.,ltd, this product is identified by NDC 80671-003 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80671-003-80
Package Description
1 BAG in 1 PAIL / 800 PACKAGE in 1 BAG / 4.6 mL in 1 PACKAGE
Product Code
80671-003
11-Digit Billing Format
80671000380
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Suresafe Antibacterial Wipes
Dosage Form
-
Usage Information
Adults and Children over 2 years:Thoroughly clean hands or affected area and discard in waste. Do not flush. Allow to dry without wiping.

Regulatory & Marketing

Labeler Name
Quanzhou Aiwina Hygiene Products 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
02-28-2021
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80671-003-80 identifies a specific commercial package of 1 bag in 1 pail / 800 package in 1 bag / 4.6 ml in 1 package of Suresafe Antibacterial Wipes, labeled by Quanzhou Aiwina Hygiene Products 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 Quanzhou Aiwina Hygiene Products Co.,ltd on February 28, 2021. The current certification is valid through December 31, 2022.

How is this Quanzhou Aiwina Hygiene Products Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80671000380. 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)
80671-003-80
11-Digit CMS (5-4-2)
80671-0003-80

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