Theraflu Powder, For Solution
NDC Package 0067-6426-06
Package Information
Theraflu (acetaminophen, dextromethorphan hbr, 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 0067-6426 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
- RxCUI: 1189316 - APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 0067 - Haleon Us Holdings Llc
- 0067-6426 - Theraflu
- 0067-6426-06 - 6 PACKET in 1 CARTON / 237 mL in 1 PACKET (0067-6426-01)
- 0067-6426 - Theraflu
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0067-6426-06 identifies a specific commercial package of 6 packet in 1 carton / 237 ml in 1 packet (0067-6426-01) of Theraflu Multi-symptom Severe Cold, a human over the counter drug labeled by Haleon Us Holdings Llc. This powder, for solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; 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 01, 2014. 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: 00067642606. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.