Nighttime Cold And Flu Relief Liquid
NDC Package 83324-159-08
Package Information
Nighttime Cold And Flu Relief (acetaminophen dextromethorphan hbr doxylamine succinate) liquids is do not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour periodmeasure only with dosing cup provided. This formulation utilizes a liquid delivery system. Marketed by Quality Choice (chain Drug Marketing Association), this product is identified by NDC 83324-159 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
- RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
- RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
- RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
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
- 83324 - Quality Choice (chain Drug Marketing Association)
- 83324-159 - Nighttime Cold And Flu Relief
- 83324-159-08 - 237 mL in 1 BOTTLE, PLASTIC
- 83324-159 - 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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 83324-159-08 identifies a specific commercial package of 237 ml in 1 bottle, plastic of Nighttime Cold And Flu Relief, a human over the counter drug labeled by Quality Choice (chain Drug Marketing Association). This liquid 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 Quality Choice (chain Drug Marketing Association) on July 31, 2024. The current certification is valid through December 31, 2026.
How is this Quality Choice (chain Drug Marketing Association) product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 83324015908. 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.