Cvs Nighttime Cold Solution
NDC Package 51316-641-12

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

Package Information

Cvs Nighttime Cold (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride) solution is •take only as directed•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use. This formulation utilizes a solution delivery system. Marketed by Cvs Pharmacy, this product is identified by NDC 51316-641 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
51316-641-12
Package Description
354 mL in 1 BOTTLE, PLASTIC
Product Code
51316-641
11-Digit Billing Format
51316064112
RxNorm Crosswalk
  • RxCUI: 1431245 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution
  • RxCUI: 1431245 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1431245 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1431245 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1431245 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Cvs Nighttime Cold
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine 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
•take only as directed•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Regulatory & Marketing

Labeler Name
Cvs Pharmacy
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-09-2023
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 51316-641-12 identifies a specific commercial package of 354 ml in 1 bottle, plastic of Cvs Nighttime Cold, a human over the counter drug labeled by Cvs Pharmacy. This solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate; 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 Cvs Pharmacy on January 09, 2023. The current certification is valid through December 31, 2026.

How is this Cvs Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316064112. 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)
51316-641-12
11-Digit CMS (5-4-2)
51316-0641-12

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