Alka-seltzer Plus Severe Cold Powerfast Fizz Night Tablet, Effervescent
NDC Package 0280-0021-01

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 Night (aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate) tablets is directions● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 6 hours. This formulation utilizes a tablet, effervescent delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0021 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0280-0021-01
Package Description
10 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH
Product Code
0280-0021
11-Digit Billing Format
00280002101
RxNorm Crosswalk
  • RxCUI: 1536503 - aspirin 500 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
  • RxCUI: 1536503 - aspirin 500 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
  • RxCUI: 1536503 - ASA 500 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet

Clinical Specifications

Proprietary Name
Alka-seltzer Plus Severe Cold Powerfast Fizz Night
Non-Proprietary Name
Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate
Substance Name
Aspirin; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Bitartrate
Dosage Form
Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Directions● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 6 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.● children under 12 years: do not use

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2020
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 0280-0021-01 identifies a specific commercial package of 10 pouch in 1 carton / 2 tablet, effervescent in 1 pouch of Alka-seltzer Plus Severe Cold Powerfast Fizz Night, a human over the counter drug labeled by Bayer Healthcare Llc.. This tablet, effervescent is formulated for oral use and contains aspirin; dextromethorphan hydrobromide; doxylamine succinate; 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 April 01, 2020. 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: 00280002101. 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)
0280-0021-01
11-Digit CMS (5-4-2)
00280-0021-01

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