Severe Cough Cold And Flu Solution
NDC Package 51316-189-34

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

Severe Cough Cold And Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin) solution is •do not take more than 5 doses in any 24-hour period•do not exceed recommended dosage. This formulation utilizes a solution delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-189 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-189-34
Package Description
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
Product Code
51316-189
11-Digit Billing Format
51316018934
RxNorm Crosswalk
  • RxCUI: 2680300 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution
  • RxCUI: 2680300 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 2680300 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution
  • RxCUI: 2680300 - APAP 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Severe Cough Cold And Flu
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not take more than 5 doses in any 24-hour period•do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.•measure only with dosing cup provided•keep dosing cup with product•mL = milliliter•this adult product is not intended for use in children under 12 years of age agedoseadults and children12 years and over20 mL every 4 hourschildren under 12 yearsdo not use

Regulatory & Marketing

Labeler Name
Cvs Woonsocket Prescription Center, Incorporated
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-29-2025
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 (51316-189). Click a package code to view its specific billing and regulatory data.

51316-189-26
1 BOTTLE in 1 CARTON / 118 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 51316-189-34 identifies a specific commercial package of 1 bottle in 1 carton / 237 ml in 1 bottle of Severe Cough Cold And Flu, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. This solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin 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 August 29, 2025. The current certification is valid through December 31, 2026.

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: 51316018934. 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)
51316-189-34
11-Digit CMS (5-4-2)
51316-0189-34

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