Respected Roots Hand Sanitizer With Aloe Vera
NDC Package 80028-0000-1

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.

Respected Roots Hand Sanitizer With Aloe Vera is place enough product on hands to cover all surfaces. Marketed by Respected Roots, Llc, this product is identified by NDC 80028-0000 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80028-0000-1
Package Description
.059 L in 1 BOTTLE, SPRAY
Product Code
80028-0000
11-Digit Billing Format
80028000001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Respected Roots Hand Sanitizer With Aloe Vera
Dosage Form
-
Usage Information
Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Respected Roots, 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
08-03-2020
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 80028-0000-1 identifies a specific commercial package of .059 l in 1 bottle, spray of Respected Roots Hand Sanitizer With Aloe Vera, labeled by Respected Roots, 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 Respected Roots, Llc on August 03, 2020. The current certification is valid through December 31, 2021.

How is this Respected Roots, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80028000001. 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 (5-4-1)
80028-0000-1
11-Digit CMS (5-4-2)
80028-0000-01

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