Organix Complete
NDC Package 61941-0122-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Organix Complete is adults and children 5 years and older: Dissolve 2 drops (one at a time) slowly in the mouth. Marketed by Prophase Labs, Inc., this product is identified by NDC 61941-0122 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
61941-0122-2
Package Description
48 PACKAGE in 1 CASE / 21 LOZENGE in 1 PACKAGE (61941-0122-1)
Product Code
11-Digit Billing Format
61941012202
RxNorm Crosswalk
  • RxCUI: 1111086 - Organix Complete 2.5 MG / 1.7 MG Oral Lozenge
  • RxCUI: 1111086 - menthol 2.5 MG / pectin 1.7 MG Oral Lozenge [Organix Complete]
  • RxCUI: 1111086 - Organix Complete (menthol 2.5 MG / pectin 1.7 MG) Oral Lozenge
  • RxCUI: 749244 - menthol 2.5 MG / pectin 1.7 MG Oral Lozenge

Clinical Specifications

Proprietary Name
Organix Complete
Dosage Form
-
Usage Information
Adults and children 5 years and older: Dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.children under 5 years: ask a doctor

Regulatory & Marketing

Labeler Name
Prophase Labs, Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
11-01-2010
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 61941-0122-2 identifies a specific commercial package of 48 package in 1 case / 21 lozenge in 1 package (61941-0122-1) of Organix Complete, labeled by Prophase 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 Prophase Labs, Inc. on November 01, 2010. The current certification is valid through December 31, 2018.

How is this Prophase Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61941012202. 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)
61941-0122-2
11-Digit CMS (5-4-2)
61941-0122-02

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