Nighttime Severe Cold And Cough
NDC Package 55319-451-06

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Nighttime Severe Cold And Cough is ▪do not use more than directed▪take every 4 hours while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctorAgeDoseadults and children 12 years of age and over one packet children under 12 years of agedo not use▪dissolve contents of one packet into 8 oz. Marketed by Family Dollar Services Inc, this product is identified by NDC 55319-451 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
55319-451-06
Package Description
6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET
Product Code
55319-451
11-Digit Billing Format
55319045106
RxNorm Crosswalk
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1659960 - APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution

Clinical Specifications

Proprietary Name
Nighttime Severe Cold And Cough
Dosage Form
-
Usage Information
▪do not use more than directed▪take every 4 hours while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctorAgeDoseadults and children 12 years of age and over one packet children under 12 years of agedo not use▪dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.▪if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Regulatory & Marketing

Labeler Name
Family Dollar Services Inc
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-03-2023
Listing Expiration
12-31-2024
Exclude Flag
I
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 55319-451-06 identifies a specific commercial package of 6 packet in 1 carton / 1 powder, for solution in 1 packet of Nighttime Severe Cold And Cough, labeled by Family Dollar Services Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Family Dollar Services Inc on July 03, 2023. The current certification is valid through December 31, 2024.

How is this Family Dollar Services Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55319045106. 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)
55319-451-06
11-Digit CMS (5-4-2)
55319-0451-06

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