Theochem Tea Tree Hand And Body Wash
NDC Package 68878-561-05

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.

Theochem Tea Tree Hand And Body Wash is for Use with Dispenser:Pour contents into the dispenser reservoir. Marketed by Theochem Laboratories, this product is identified by NDC 68878-561 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
68878-561-05
Package Description
2 BOTTLE, PLASTIC in 1 CASE / 3.785 L in 1 BOTTLE, PLASTIC (68878-561-02)
Product Code
68878-561
11-Digit Billing Format
68878056105

Clinical Specifications

Proprietary Name
Theochem Tea Tree Hand And Body Wash
Dosage Form
-
Usage Information
For Use with Dispenser:Pour contents into the dispenser reservoir. For first use applications, pump dispenser a few times to prime.For Use as Hand Soap:Wet hands and dispense a small amount of the product into palm. Rub hands to produce lather. Rinse thoroughly with water, then dry hands completely.For Use as Bath and Body Wash:Apply sparingly. Avoid contact with eyes. Lather and rinse.

Regulatory & Marketing

Labeler Name
Theochem Laboratories
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
08-08-2017
Listing Expiration
12-31-2018
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 68878-561-05 identifies a specific commercial package of 2 bottle, plastic in 1 case / 3.785 l in 1 bottle, plastic (68878-561-02) of Theochem Tea Tree Hand And Body Wash, labeled by Theochem Laboratories. 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 Theochem Laboratories on August 08, 2017. The current certification is valid through December 31, 2018.

How is this Theochem Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68878056105. 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)
68878-561-05
11-Digit CMS (5-4-2)
68878-0561-05

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