Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Kit
NDC Package 0280-0109-01

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

Package Information

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night (aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate) kits is uses temporarily relieves these symptoms due to a cold with cough: minor aches and painsheadachesinus congestion and pressurecoughsore throatnasal congestiontemporarily reduces fever Uses temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressure cough sneezingsore throat nasal congestiontemporarily reduces fever. This formulation utilizes a kit delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0109 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0280-0109-01
Package Description
1 KIT in 1 CARTON * 2 TABLET, EFFERVESCENT in 1 POUCH * 2 TABLET, EFFERVESCENT in 1 POUCH
Product Code
0280-0109
11-Digit Billing Format
00280010901
RxNorm Crosswalk
  • RxCUI: 1536498 - aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
  • RxCUI: 1536498 - aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
  • RxCUI: 1536498 - ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
  • 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

Clinical Specifications

Proprietary Name
Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night
Non-Proprietary Name
Aspirin, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Uses temporarily relieves these symptoms due to a cold with cough: minor aches and painsheadachesinus congestion and pressurecoughsore throatnasal congestiontemporarily reduces fever Uses temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressure cough sneezingsore throat nasal congestiontemporarily reduces fever

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-05-2021
Listing Expiration
12-31-2027
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 0280-0109-01 identifies a specific commercial package of 1 kit in 1 carton * 2 tablet, effervescent in 1 pouch * 2 tablet, effervescent in 1 pouch of Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night, a human over the counter drug labeled by Bayer Healthcare Llc.. This kit is formulated for oral 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 Bayer Healthcare Llc. on August 05, 2021. The current certification is valid through December 31, 2027.

How is this Bayer Healthcare Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00280010901. 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)
0280-0109-01
11-Digit CMS (5-4-2)
00280-0109-01

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