Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief Kit
NDC Package 68016-879-48

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 Multi-symptom Relief/cold And Flu Nighttime Relief (acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate) kits is take only as directed – see Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 yrs & over 2 capsules with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing. This formulation utilizes a kit delivery system. Marketed by Chain Drug Consortium, Llc, this product is identified by NDC 68016-879 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
68016-879-48
Package Description
1 KIT in 1 PACKAGE * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
Product Code
68016-879
11-Digit Billing Format
68016087948
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: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief
Non-Proprietary Name
Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Doxylamine Succinate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Take only as directed – see Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 yrs & over 2 capsules with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Regulatory & Marketing

Labeler Name
Chain Drug Consortium, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-12-2019
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 68016-879-48 identifies a specific commercial package of 1 kit in 1 package * 16 blister pack in 1 carton / 2 capsule in 1 blister pack * 8 blister pack in 1 carton / 2 capsule in 1 blister pack of Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief, a human over the counter drug labeled by Chain Drug Consortium, 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 Chain Drug Consortium, Llc on July 12, 2019. The current certification is valid through December 31, 2026.

How is this Chain Drug Consortium, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016087948. 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)
68016-879-48
11-Digit CMS (5-4-2)
68016-0879-48

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