Ultra Concentrated Daytime/ Nighttime Severe Softgel Kit
NDC Package 51316-547-24

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

Package Information

Ultra Concentrated Daytime/ Nighttime Severe Softgel (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride softgel) kits is usestemporarily relieves these symptoms due to a cold or flu: - minor aches and pains - headache - nasal congestion - sore throat - sinus congestion and pressure - coughtemporarily reduces fever Usestemporarily relieves these symptoms due to a cold or flu: - minor aches and pains - headache - nasal congestion - cough - sinus congestion and pressure - runny nose - sneezing - sore throat temporarily reduces fever. This formulation utilizes a kit delivery system. Marketed by Cvs Pharmacy, Inc, this product is identified by NDC 51316-547 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-547-24
Package Description
2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK
Product Code
51316-547
11-Digit Billing Format
51316054724
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
Ultra Concentrated Daytime/ Nighttime Severe Softgel
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride Softgel
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Usestemporarily relieves these symptoms due to a cold or flu: - minor aches and pains - headache - nasal congestion - sore throat - sinus congestion and pressure - coughtemporarily reduces fever Usestemporarily relieves these symptoms due to a cold or flu: - minor aches and pains - headache - nasal congestion - cough - sinus congestion and pressure - runny nose - sneezing - sore throat temporarily reduces fever

Regulatory & Marketing

Labeler Name
Cvs Pharmacy, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2025
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 51316-547-24 identifies a specific commercial package of 2 blister pack in 1 carton / 1 kit in 1 blister pack * 8 capsule in 1 blister pack * 4 capsule in 1 blister pack of Ultra Concentrated Daytime/ Nighttime Severe Softgel, a human over the counter drug labeled by Cvs Pharmacy, Inc. 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 Cvs Pharmacy, Inc on February 01, 2025. The current certification is valid through December 31, 2027.

How is this Cvs Pharmacy, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316054724. 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)
51316-547-24
11-Digit CMS (5-4-2)
51316-0547-24

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