Alka-seltzer Plus Multi-symptom Cold And Flu Day And Night Kit
NDC Package 0280-1138-20

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 Multi-symptom Cold And Flu Day And Night (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl) kits is directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with water every 4 hours. This formulation utilizes a kit delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-1138 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0280-1138-20
Package Description
1 KIT in 1 CARTON * 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
0280-1138
11-Digit Billing Format
00280113820
RxNorm Crosswalk
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Alka-seltzer Plus Multi-symptom Cold And Flu Day And Night Liquid Gels
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.· children under 12 years: do not use Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. Do not exceed 10 capsules in 24 hours or asdirected 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
07-15-2016
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 0280-1138-20 identifies a specific commercial package of 1 kit in 1 carton * 10 capsule, liquid filled in 1 blister pack * 10 capsule, liquid filled in 1 blister pack of Alka-seltzer Plus Multi-symptom Cold And Flu Day And Night Liquid Gels, 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 July 15, 2016. 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: 00280113820. 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)
0280-1138-20
11-Digit CMS (5-4-2)
00280-1138-20

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