Theraflu Flu Relief Maximum Strength Kit
NDC Package 0067-8161-01

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

Package Information

Theraflu Flu Relief Maximum Strength (acetaminophen, dextromethorphan hbr and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr) kits is •do not use more than directed•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist•do not take more than 6 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use •do not use more than directed•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist•do not take more than 6 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use. This formulation utilizes a kit delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-8161 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-8161-01
Package Description
1 KIT in 1 CARTON * 20 TABLET in 1 BLISTER PACK (0067-8162-01) * 20 TABLET in 1 BLISTER PACK (0067-8163-01)
Product Code
0067-8161
11-Digit Billing Format
00067816101
RxNorm Crosswalk
  • RxCUI: 1098496 - acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 1098496 - acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet
  • RxCUI: 1098496 - APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet
  • RxCUI: 247324 - acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 247324 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet

Clinical Specifications

Proprietary Name
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
Dosage Form
Kit - A packaged collection of related material.
Usage Information
•do not use more than directed•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist•do not take more than 6 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use •do not use more than directed•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist•do not take more than 6 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-27-2022
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 0067-8161-01 identifies a specific commercial package of 1 kit in 1 carton * 20 tablet in 1 blister pack (0067-8162-01) * 20 tablet in 1 blister pack (0067-8163-01) of Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack, a human over the counter drug labeled by Haleon Us Holdings Llc. This kit is formulated for use and contains 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 June 27, 2022. 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: 00067816101. 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)
0067-8161-01
11-Digit CMS (5-4-2)
00067-8161-01

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