Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr Kit
NDC Package 51316-984-03

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

Package Information

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr kits is do not use more than directedadults and children 12 years and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctorchildren under 12 years of age: do not use AgeDoseadults and children 12 years of age and over2 caplets every 6 hourschildren under 12 years of agedo not use do not use more than directedadults and children 12 years and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctorchildren under 12 years of age: do not use AgeDoseadults and children 12 years of age and over2 caplets every 6 hourschildren under 12 years of agedo not use. This formulation utilizes a kit delivery system. Marketed by Cvs Pharmacy, Inc, this product is identified by NDC 51316-984 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-984-03
Package Description
1 KIT in 1 CARTON * 10 TABLET, FILM COATED in 1 BLISTER PACK (51316-983-01) * 10 TABLET, FILM COATED in 1 BLISTER PACK (51316-451-01)
Product Code
51316-984
11-Digit Billing Format
51316098403
RxNorm Crosswalk
  • RxCUI: 1098496 - acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 1098496 - acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet
  • RxCUI: 1098496 - APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet
  • RxCUI: 247324 - acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 247324 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
Non-Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Do not use more than directedadults and children 12 years and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctorchildren under 12 years of age: do not use AgeDoseadults and children 12 years of age and over2 caplets every 6 hourschildren under 12 years of agedo not use do not use more than directedadults and children 12 years and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctorchildren under 12 years of age: do not use AgeDoseadults and children 12 years of age and over2 caplets every 6 hourschildren under 12 years of agedo not use

Regulatory & Marketing

Labeler Name
Cvs Pharmacy, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-10-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51316-984-03 identifies a specific commercial package of 1 kit in 1 carton * 10 tablet, film coated in 1 blister pack (51316-983-01) * 10 tablet, film coated in 1 blister pack (51316-451-01) of Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr, a human over the counter drug labeled by Cvs Pharmacy, Inc. This kit is formulated for oral use and contains 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 Cvs Pharmacy, Inc on July 10, 2024. The current certification is valid through December 31, 2026.

How is this Cvs Pharmacy, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316098403. 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)
51316-984-03
11-Digit CMS (5-4-2)
51316-0984-03

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