Unishield Cough And Cold
NDC Package 49314-4358-0

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.

Unishield Cough And Cold is uses Temporarily relieves these symptoms due to the common cold: ■ headache ■ nasal congestion ■ cough ■ minor aches and pains ■ sore throat ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive Temporarily reduces fever. Marketed by Unishield, this product is identified by NDC 49314-4358 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
49314-4358-0
Package Description
40 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET
Product Code
49314-4358
11-Digit Billing Format
49314435800
RxNorm Crosswalk
  • RxCUI: 1098435 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1098435 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1098435 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Unishield Cough And Cold
Dosage Form
-
Usage Information
Uses Temporarily relieves these symptoms due to the common cold: ■ headache ■ nasal congestion ■ cough ■ minor aches and pains ■ sore throat ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive Temporarily reduces fever.

Regulatory & Marketing

Labeler Name
Unishield
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-26-2022
Listing Expiration
12-31-2025
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 49314-4358-0 identifies a specific commercial package of 40 packet in 1 box / 2 tablet, film coated in 1 packet of Unishield Cough And Cold, labeled by Unishield. 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 Unishield on September 26, 2022. The current certification is valid through December 31, 2025.

How is this Unishield product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49314435800. 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)
49314-4358-0
11-Digit CMS (5-4-2)
49314-4358-00

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