Alcohol Agent Sanitizer
NDC Package 58418-159-20

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.

Alcohol Agent Sanitizer is uses: For handwashing to decrease bacteria on the skin.When using this product avoid contact with eyes. Marketed by Tropical Enterprises International, Inc., this product is identified by NDC 58418-159 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
58418-159-20
Package Description
20 mL in 1 BOTTLE, SPRAY
Product Code
58418-159
11-Digit Billing Format
58418015920

Clinical Specifications

Proprietary Name
Alcohol Agent Sanitizer
Dosage Form
-
Usage Information
Uses: For handwashing to decrease bacteria on the skin.When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.

Regulatory & Marketing

Labeler Name
Tropical Enterprises International, Inc.
FDA Application #
part333E
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
01-01-2021
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 58418-159-20 identifies a specific commercial package of 20 ml in 1 bottle, spray of Alcohol Agent Sanitizer, labeled by Tropical Enterprises International, Inc.. 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 Tropical Enterprises International, Inc. on January 01, 2021. The current certification is valid through December 31, 2021.

How is this Tropical Enterprises International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58418015920. 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)
58418-159-20
11-Digit CMS (5-4-2)
58418-0159-20

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