Theraflu Flu Relief Max Strength Powder
NDC Package 0067-7921-02

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 Max Strength (acetaminophen, dextromethorphan hbr) powders is •do not use more than directed•take every 6 hours, while symptoms persist. This formulation utilizes a powder delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-7921 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-7921-02
Package Description
6 POWDER in 1 CARTON
Product Code
0067-7921
11-Digit Billing Format
00067792102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk
  • RxCUI: 2636656 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution
  • RxCUI: 2636656 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution
  • RxCUI: 2636656 - APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution
  • RxCUI: 2636658 - acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral Solution
  • RxCUI: 2636658 - acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Theraflu Flu Relief Max Strength Daytime
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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 6 hours, while symptoms persist. Do not take more than 3 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. •do not use more than directed•take every 6 hours, while symptoms persist. Do not take more than 3 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
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-15-2022
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 0067-7921-02 identifies a specific commercial package of 6 powder in 1 carton of Theraflu Flu Relief Max Strength Daytime, a human over the counter drug labeled by Haleon Us Holdings Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. This powder is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide 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 15, 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: 00067792102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 total billable units per package. 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)
0067-7921-02
11-Digit CMS (5-4-2)
00067-7921-02

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