Cold Medicine Tablet
NDC Package 76095-010-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Cold Medicine (acetaminophen chlorpheniramine maleate phenylepherine hydrochloride) tablets is ■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age. This formulation utilizes a tablet delivery system. Marketed by Midway Importing Inc., this product is identified by NDC 76095-010 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76095-010-50
Package Description
50 PACKET in 1 BOX / 4 TABLET in 1 PACKET (76095-010-04)
Product Code
76095-010
11-Digit Billing Format
76095001050
RxNorm Crosswalk
  • RxCUI: 1193293 - acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1193293 - acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet
  • RxCUI: 1193293 - APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Cold Medicine Xl3 Forte
Non-Proprietary Name
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Regulatory & Marketing

Labeler Name
Midway Importing Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76095-010). Click a package code to view its specific billing and regulatory data.

76095-010-10
1 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK (76095-010-01)
76095-010-20
2 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK (76095-010-02)

* 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 76095-010-50 identifies a specific commercial package of 50 packet in 1 box / 4 tablet in 1 packet (76095-010-04) of Cold Medicine Xl3 Forte, a human over the counter drug labeled by Midway Importing Inc.. This tablet is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Midway Importing Inc. on August 01, 2017. The current certification is valid through December 31, 2026.

How is this Midway Importing Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76095001050. 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)
76095-010-50
11-Digit CMS (5-4-2)
76095-0010-50

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