Theraflu Severe Cold Relief Nighttime Powder, For Solution
NDC Package 0067-0101-06

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 hcl) powders is • do not use more than directed• take every 4 hours, while symptoms persist. This formulation utilizes a powder, for solution delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-0101 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-0101-06
Package Description
6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET
Product Code
0067-0101
11-Digit Billing Format
00067010106
RxNorm Crosswalk
  • RxCUI: 2670598 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution
  • RxCUI: 2670598 - APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution
  • 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

Clinical Specifications

Proprietary Name
Theraflu Severe Cold Relief Nighttime
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hcl
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 directed• take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo 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
Haleon Us Holdings Llc
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 0067-0101-06 identifies a specific commercial package of 6 packet in 1 carton / 1 powder, for solution in 1 packet of Theraflu Severe Cold Relief Nighttime, a human over the counter drug labeled by Haleon Us Holdings Llc. 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 Haleon Us Holdings Llc on December 01, 2023. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00067010106. 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)
0067-0101-06
11-Digit CMS (5-4-2)
00067-0101-06

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