Night Time Severe Cold And Flu Liquid
NDC Package 0363-0331-26

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

Package Information

Night Time Severe Cold And Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl) liquids is uses Temporarily relieves cold/flu symptoms: ■ nasalcongestion ■ sinus congestion & pressure ■ sore throat■ headache ■ minor aches and pain ■ runny nose andsneezing ■ temporarily reduces fever ■ cough due tominor throat and bronchial irritation ■ promotes nasaland/or sinus drainage. This formulation utilizes a liquid delivery system. Marketed by Walgreen Company, this product is identified by NDC 0363-0331 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0363-0331-26
Package Description
237 mL in 1 BOTTLE
Product Code
0363-0331
11-Digit Billing Format
00363033126
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
Night Time Severe Cold And Flu
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Uses Temporarily relieves cold/flu symptoms: ■ nasalcongestion ■ sinus congestion & pressure ■ sore throat■ headache ■ minor aches and pain ■ runny nose andsneezing ■ temporarily reduces fever ■ cough due tominor throat and bronchial irritation ■ promotes nasaland/or sinus drainage

Regulatory & Marketing

Labeler Name
Walgreen Company
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-13-2020
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 0363-0331-26 identifies a specific commercial package of 237 ml in 1 bottle of Night Time Severe Cold And Flu, a human over the counter drug labeled by Walgreen Company. This liquid 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 Walgreen Company on November 13, 2020. The current certification is valid through December 31, 2026.

How is this Walgreen Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363033126. 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 (4-4-2)
0363-0331-26
11-Digit CMS (5-4-2)
00363-0331-26

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