Nighttime Cold And Flu Relief Capsule, Liquid Filled
NDC Package 55319-968-08
Package Information
Nighttime Cold And Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) capsules is do not take more than directed (see Overdose warning)do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 6 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Family Dollar (family Wellness), this product is identified by NDC 55319-968 and is authorized under FDA application M012.
Identification & Billing
- 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
- RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
Clinical Specifications
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
Regulatory & Marketing
Hierarchy Structure
- 55319 - Family Dollar (family Wellness)
- 55319-968 - Nighttime Cold And Flu Relief
- 55319-968-08 - 8 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 55319-968 - Nighttime Cold And Flu Relief
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (55319-968). Click a package code to view its specific billing and regulatory data.
* 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 55319-968-08 identifies a specific commercial package of 8 blister pack in 1 carton / 1 capsule, liquid filled in 1 blister pack of Nighttime Cold And Flu Relief, a human over the counter drug labeled by Family Dollar (family Wellness). This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate 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 Family Dollar (family Wellness) on July 01, 2023. The current certification is valid through December 31, 2026.
How is this Family Dollar (family Wellness) product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 55319096808. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.