Nighttime Severe Cold And Cough Powder, For Solution
NDC Package 41226-541-06

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

Package Information

Nighttime Severe Cold And Cough (acetaminophen, diphenhydramine, phenylephrine) powders is ▪do not use more than directed▪take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctorAgeDosechildren under 12 years of agedo not use adults and children 12 years of age and overone packet▪dissolve contents of one packet into 8 oz. This formulation utilizes a powder, for solution delivery system. Marketed by Kroger Company, this product is identified by NDC 41226-541 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
41226-541-06
Package Description
6 POWDER, FOR SOLUTION in 1 CARTON
Product Code
41226-541
11-Digit Billing Format
41226054106
RxNorm Crosswalk
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1659960 - APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution

Clinical Specifications

Proprietary Name
Nighttime Severe Cold And Cough
Non-Proprietary Name
Acetaminophen, Diphenhydramine, Phenylephrine
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
▪do not use more than directed▪take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctorAgeDosechildren under 12 years of agedo not use adults and children 12 years of age and overone packet▪dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.▪if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Regulatory & Marketing

Labeler Name
Kroger Company
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-15-2024
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 41226-541-06 identifies a specific commercial package of 6 powder, for solution in 1 carton of Nighttime Severe Cold And Cough, a human over the counter drug labeled by Kroger Company. This powder, for solution is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride; 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 Kroger Company on January 15, 2024. The current certification is valid through December 31, 2026.

How is this Kroger Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41226054106. 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)
41226-541-06
11-Digit CMS (5-4-2)
41226-0541-06

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