Alka-seltzer Plus Severe Cold Night Powerfast Fizz Tablet, Effervescent
NDC Package 0280-0121-01
Package Information
Alka-seltzer Plus Severe Cold Night Powerfast Fizz (aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate) tablets is uses temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressurecoughsneezingsore throatnasal congestiontemporarily reduces fever. This formulation utilizes a tablet, effervescent delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0121 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1537029 - aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
- RxCUI: 1537029 - aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
- RxCUI: 1537029 - ASA 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Decreased Platelet Aggregation - [PE] (Physiologic Effect)
- Decreased Prostaglandin Production - [PE] (Physiologic Effect)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
- 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
- 0280 - Bayer Healthcare Llc.
- 0280-0121 - Alka-seltzer Plus Severe Cold Night Powerfast Fizz
- 0280-0121-01 - 12 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH
- 0280-0121 - Alka-seltzer Plus Severe Cold Night Powerfast Fizz
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 (0280-0121). Click a package code to view its specific billing and regulatory data.
* 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 0280-0121-01 identifies a specific commercial package of 12 pouch in 1 carton / 2 tablet, effervescent in 1 pouch of Alka-seltzer Plus Severe Cold Night Powerfast Fizz, a human over the counter drug labeled by Bayer Healthcare Llc.. This tablet, effervescent is formulated for oral use and contains aspirin; chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine bitartrate 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 Bayer Healthcare Llc. on May 24, 2023. The current certification is valid through December 31, 2026.
How is this Bayer Healthcare Llc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00280012101. 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.