Home NDC 84324-024 Nuvicare NightTime Cold and Flu Softgel
Product NDC 84324-024
11-digit product format 843240024
Labeler code 84324
Product ID 84324-024_baf65fbc-067d-4642-9612-93cc416b5639
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, Doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler NUVICARE LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-09
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nuvicare NightTime Cold and Flu Softgel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84324-024-01 Nuvicare NightTime Cold and Flu Softgel 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 84324-024-01 Nuvicare NightTime Cold and Flu Softgel 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84324-024-01 84324002401 1 BLISTER PACK in 1 CARTON (84324-024-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2025-06-09 No No Current