Cold Remedy Soothing
NDC Package 51367-002-12

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 Remedy Soothing is adults and children 12 years of age and olderTake 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hoursChildren ages 6 to 12 years oldTake 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hoursChildren under 6 years of ageConsult a doctor. Marketed by International Nature Nutraceuticals, this product is identified by NDC 51367-002 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
51367-002-12
Package Description
12 TABLET in 1 BOX
Product Code
51367-002
11-Digit Billing Format
51367000212
RxNorm Crosswalk
  • RxCUI: 1304074 - chlorpheniramine maleate 1.05 MG / acetaminophen 105 MG Oral Tablet
  • RxCUI: 1304074 - acetaminophen 105 MG / chlorpheniramine maleate 1.05 MG Oral Tablet
  • RxCUI: 1304074 - APAP 105 MG / Chlorpheniramine Maleate 1.05 MG Oral Tablet

Clinical Specifications

Proprietary Name
Cold Remedy Soothing
Dosage Form
-
Usage Information
Adults and children 12 years of age and olderTake 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hoursChildren ages 6 to 12 years oldTake 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hoursChildren under 6 years of ageConsult a doctor

Regulatory & Marketing

Labeler Name
International Nature Nutraceuticals
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-24-1987
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 51367-002-12 identifies a specific commercial package of 12 tablet in 1 box of Cold Remedy Soothing, labeled by International Nature Nutraceuticals. 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 International Nature Nutraceuticals on February 24, 1987. The current certification is valid through December 31, 2017.

How is this International Nature Nutraceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51367000212. 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)
51367-002-12
11-Digit CMS (5-4-2)
51367-0002-12

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