Cold-eeze
NDC Package 61941-0225-4

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.

Cold-eeze is take Cold-EEZE® Daytime QuickMelts® when you have cold symptomsAdults and Children 12 years and over:Dissolve entire tablet in mouth. Marketed by Prophase Labs, Inc., this product is identified by NDC 61941-0225.

Identification & Billing

NDC Package Code
61941-0225-4
Package Description
1 KIT in 1 CARTON * 18 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK * 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
61941-0225
11-Digit Billing Format
61941022504

Clinical Specifications

Proprietary Name
Cold-eeze Daytime And Nighttime Quickmelts
Dosage Form
-
Usage Information
Take Cold-EEZE® Daytime QuickMelts® when you have cold symptomsAdults and Children 12 years and over:Dissolve entire tablet in mouth. Do not chew.Do not swallow whole.Take 1 tablet at the onset of symptoms.Repeat every 2-4 hours as needed until all symptoms subside.Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids.Recommended daily dose is 6 tablets for adults and 4 tablets for ages 12-17 years.For children under 12 years of age, consult a healthcare practitioner before use. Take Cold-EEZE® Nighttime QuickMelts® at night when you have cold symptoms.Adults;Dissolve entire tablet in mouth. Do not chew.Do not swallow whole.Take 1 Nighttime tablet 1 hour before bedtime.Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids.Recommended dose is 1 tablet for adults.For individuals under the age of 18, consult a healthcare practitioner before use.

Regulatory & Marketing

Labeler Name
Prophase Labs, Inc.
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
12-01-2014
Listing Expiration
12-31-2017
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 61941-0225-4 identifies a specific commercial package of 1 kit in 1 carton * 18 tablet, orally disintegrating in 1 blister pack * 6 tablet, orally disintegrating in 1 blister pack of Cold-eeze Daytime And Nighttime Quickmelts, 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 December 01, 2014. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61941022504. 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)
61941-0225-4
11-Digit CMS (5-4-2)
61941-0225-04

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