Alka Seltzer Cold Cold Flu Congestion Severe Fast Hot Liquid Day Night Kit
NDC Package 0280-8284-12

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

Package Information

Alka Seltzer Cold Cold Flu Congestion Severe Fast Hot Liquid Day Night (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate) kits is do not take more than the recommended doseadults and children 12 years and over:take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctordissolve contents of one packet in 8 oz. This formulation utilizes a kit delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-8284 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0280-8284-12
Package Description
1 KIT in 1 CARTON * 1 POWDER, FOR SOLUTION in 1 PACKET * 1 POWDER, FOR SOLUTION in 1 PACKET
Product Code
0280-8284
11-Digit Billing Format
00280828412
RxNorm Crosswalk
  • RxCUI: 1534835 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution
  • RxCUI: 1534835 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1534835 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1534835 - APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1550968 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Alka Seltzer Cold Cold Flu Congestion Severe Fast Hot Liquid Day Night
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Doxylamine Succinate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Do not take more than the recommended doseadults and children 12 years and over:take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctordissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.children under 12 years: do not use do not take more than the recommended doseadults and children 12 years and over : take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctordissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.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
06-01-2026
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 0280-8284-12 identifies a specific commercial package of 1 kit in 1 carton * 1 powder, for solution in 1 packet * 1 powder, for solution in 1 packet of Alka Seltzer Cold Cold Flu Congestion Severe Fast Hot Liquid Day Night, a human over the counter drug labeled by Bayer Healthcare Llc.. This kit is formulated for 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 June 01, 2026. 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: 00280828412. 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)
0280-8284-12
11-Digit CMS (5-4-2)
00280-8284-12

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