12 Hr Relief Cough Dm Suspension
NDC Package 51316-263-28

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

12 Hr Relief Cough Dm (dextromethorphan polistirex) suspension is a medication used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This formulation utilizes a suspension delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-263 and is authorized under FDA application ANDA091135.

Identification & Billing

NDC Package Code
51316-263-28
Package Description
1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE
Product Code
51316-263
11-Digit Billing Format
51316026328
RxNorm Crosswalk
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension

Clinical Specifications

Proprietary Name
12 Hr Relief Cough Dm
Non-Proprietary Name
Dextromethorphan Polistirex
Substance Name
Dextromethorphan Hydrobromide
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
Pharmacologic Class
Usage Information
This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Regulatory & Marketing

Labeler Name
Cvs Woonsocket Prescription Center, Incorporated
Product Type
Human Otc Drug
FDA Application #
ANDA091135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2026
Listing Expiration
12-31-2027
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 (51316-263). Click a package code to view its specific billing and regulatory data.

51316-263-21
1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE

* 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 51316-263-28 identifies a specific commercial package of 1 bottle in 1 carton / 148 ml in 1 bottle of 12 Hr Relief Cough Dm, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. This suspension is formulated for oral use and contains dextromethorphan hydrobromide 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 Woonsocket Prescription Center, Incorporated on April 14, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How is this Cvs Woonsocket Prescription Center, Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316026328. 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)
51316-263-28
11-Digit CMS (5-4-2)
51316-0263-28

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