Cold And Flu Tablet, Film Coated
NDC Package 41250-643-08

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

Package Information

Cold And Flu (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl) tablets is do not take more than directeddo not take more than 8 caplets in 24 hoursadults and children 12 years and over: take 2 caplets with water every 4 hourschildren under 12 years: ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Meijer Distribution Inc, this product is identified by NDC 41250-643 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
41250-643-08
Package Description
2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
41250-643
11-Digit Billing Format
41250064308
RxNorm Crosswalk
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1110988 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Cold And Flu Daytime Severe
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than directeddo not take more than 8 caplets in 24 hoursadults and children 12 years and over: take 2 caplets with water every 4 hourschildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Meijer Distribution Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-08-2020
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 41250-643-08 identifies a specific commercial package of 2 blister pack in 1 carton / 12 tablet, film coated in 1 blister pack of Cold And Flu Daytime Severe, a human over the counter drug labeled by Meijer Distribution Inc. This tablet, film coated is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride 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 Meijer Distribution Inc on May 08, 2020. The current certification is valid through December 31, 2027.

How is this Meijer Distribution Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41250064308. 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 (5-3-2)
41250-643-08
11-Digit CMS (5-4-2)
41250-0643-08

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