Smooth Groom Society American Edition Antibacterial Hand Wash
NDC Package 77816-503-01

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 discontinued by the firm.

Smooth Groom Society American Edition Antibacterial Hand Wash is a . Marketed by Kira Labs Inc, this product is identified by NDC 77816-503 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
77816-503-01
Package Description
480 mL in 1 BOTTLE
Product Code
77816-503
11-Digit Billing Format
77816050301

Clinical Specifications

Proprietary Name
Smooth Groom Society American Edition Antibacterial Hand Wash
Dosage Form
-

Regulatory & Marketing

Labeler Name
Kira Labs 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
10-01-2020
End Marketing Date
10-31-2022
Listing Expiration
10-31-2022
Exclude Flag
D
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 77816-503-01 identifies a specific commercial package of 480 ml in 1 bottle of Smooth Groom Society American Edition Antibacterial Hand Wash, labeled by Kira Labs 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 Kira Labs Inc on October 01, 2020. The current certification is valid through October 31, 2022.

How is this Kira Labs Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77816050301. 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)
77816-503-01
11-Digit CMS (5-4-2)
77816-0503-01

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