Disinfecting Wipes
NDC Package 80297-031-01

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.

Disinfecting Wipes is for use apply thoroughly to hands as desired. Marketed by Tmd Holdings, Llc, this product is identified by NDC 80297-031 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80297-031-01
Package Description
1050 g in 1 PAIL
Product Code
80297-031
11-Digit Billing Format
80297003101

Clinical Specifications

Proprietary Name
Disinfecting Wipes
Dosage Form
-
Usage Information
For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.For dispensing flip open dispensing cap and remove entire lid from canister by lifting upward.Locate wipe at center of roll, twist corner to a point and thread through small opening in lid.DO NOT PUSH FINGER THROUGH OPENING.Replace lid and pull sheet up at an angle. Remaining wipes feed automatically.When finished, snap lid cap shut to retain moisture.

Regulatory & Marketing

Labeler Name
Tmd Holdings, Llc
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
08-26-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80297-031-01 identifies a specific commercial package of 1050 g in 1 pail of Disinfecting Wipes, labeled by Tmd Holdings, Llc. 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 Tmd Holdings, Llc on August 26, 2020. The current certification is valid through December 31, 2021.

How is this Tmd Holdings, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80297003101. 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)
80297-031-01
11-Digit CMS (5-4-2)
80297-0031-01

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