Theraflu Severe Cold Relief Nighttime Powder, For Solution
NDC Package 50269-101-06

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

Package Information

Theraflu Severe Cold Relief Nighttime (acetaminophen, diphenhydramine hydrochloride) powders is do not use more than directedtake every 4 hours, while symptoms persist. This formulation utilizes a powder, for solution delivery system. Marketed by Jc World Bell Wholesale Co., Inc., this product is identified by NDC 50269-101 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50269-101-06
Package Description
20 PACKET in 1 BOX / 1 POWDER, FOR SOLUTION in 1 PACKET
Product Code
50269-101
11-Digit Billing Format
50269010106
RxNorm Crosswalk
  • RxCUI: 2670677 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution
  • RxCUI: 2670677 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution
  • RxCUI: 2670677 - acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution
  • RxCUI: 2670677 - acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution
  • RxCUI: 2670677 - APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Theraflu Severe Cold Relief Nighttime
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hydrochloride
Substance Name
Acetaminophen; Diphenhydramine 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 directedtake every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.  Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use• 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
Jc World Bell Wholesale Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2023
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 50269-101-06 identifies a specific commercial package of 20 packet in 1 box / 1 powder, for solution in 1 packet of Theraflu Severe Cold Relief Nighttime, a human over the counter drug labeled by Jc World Bell Wholesale Co., Inc.. This powder, for solution is formulated for oral use and contains acetaminophen; diphenhydramine 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 Jc World Bell Wholesale Co., Inc. on December 01, 2023. The current certification is valid through December 31, 2026.

How is this Jc World Bell Wholesale Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50269010106. 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)
50269-101-06
11-Digit CMS (5-4-2)
50269-0101-06

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