Nuvicare Nighttime Cold And Flu Softgel Capsule, Liquid Filled
NDC Package 84324-024-01
Package Information
Nuvicare Nighttime Cold And Flu Softgel (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) capsules is ■ take only as directed- see OVERDOSE WARNING■ do not exceed 8 softgels per 24 hrs. ■ take softgels with water Adults and children age 12 yrs and over2 softgels every 6 hrs. Children 4 to under 12 yrs ask a doctor Children under 4 yrs do not use. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Nuvicare Llc, this product is identified by NDC 84324-024 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
- 84324 - Nuvicare Llc
- 84324-024 - Nuvicare Nighttime Cold And Flu Softgel
- 84324-024-01 - 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 84324-024 - Nuvicare Nighttime Cold And Flu Softgel
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 84324-024-01 identifies a specific commercial package of 1 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack of Nuvicare Nighttime Cold And Flu Softgel, a human over the counter drug labeled by Nuvicare Llc. 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 Nuvicare Llc on June 09, 2025. The current certification is valid through December 31, 2026.
How is this Nuvicare Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 84324002401. 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.