Theraflu Powder, For Solution
NDC Package 0067-6095-01

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

Package Information

Theraflu (acetaminophen, diphenhydramine hcl, phenylephrine 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 0067-6095 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-6095-01
Package Description
8 POUCH in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6095-02)
Product Code
0067-6095
11-Digit Billing Format
00067609501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
8 EA
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
Theraflu Powerpods Nighttime Severe Cold
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
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. Do not take more than 5 pods in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone podchildren under 12 years of agedo not use•do not remove the foil seal as the pod will not work properly and could result in hot water burns •place pod in compatible brewer•use a minimum of 8 oz. of water•when finished, the pod will be hot and may drip. Tilt the pod during removal to avoid dripping.•remove used pod and flush brewer after each use with a minimum of 8 oz. of water•sip while hot. Consume entire drink within 10-15 minutes.

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-28-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0067-6095). Click a package code to view its specific billing and regulatory data.

0067-6095-03
1 POUCH in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 POUCH

* 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 0067-6095-01 identifies a specific commercial package of 8 pouch in 1 carton / 1 powder, for solution in 1 pouch (0067-6095-02) of Theraflu Powerpods Nighttime Severe Cold, 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 8 billable units per package. 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 Haleon Us Holdings Llc on July 28, 2018. 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: 00067609501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 8 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)
0067-6095-01
11-Digit CMS (5-4-2)
00067-6095-01

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