Cold And Flu Solution
NDC Package 51316-963-45

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

Package Information

Cold And Flu (acetaminophen, dextromethorphan hbr, triprolidine hcl) solution is do not take more than directeddo not take more than 4 doses in any 24-hour periodmL = milliliteronly use the dose cup providedadults and children 12 years and over: 20 mL in dosing cup provided every 4 hourschildren under 12 years: do not use. This formulation utilizes a solution delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-963 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-963-45
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
51316-963
11-Digit Billing Format
51316096345
RxNorm Crosswalk
  • RxCUI: 2173667 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution
  • RxCUI: 2173667 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution
  • RxCUI: 2173667 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution
  • RxCUI: 2173667 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Cold And Flu Nighttime
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Triprolidine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Triprolidine Hydrochloride
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 directeddo not take more than 4 doses in any 24-hour periodmL = milliliteronly use the dose cup providedadults and children 12 years and over: 20 mL in dosing cup provided every 4 hourschildren under 12 years: do 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
10-23-2023
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 51316-963-45 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Cold And Flu Nighttime, 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; triprolidine 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 Cvs Woonsocket Prescription Center, Incorporated on October 23, 2023. 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: 51316096345. 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)
51316-963-45
11-Digit CMS (5-4-2)
51316-0963-45

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