Home NDC 84324-037 Nuvicare Long-Acting Cough Relief
Product NDC 84324-037
11-digit product format 843240037
Labeler code 84324
Product ID 84324-037_85326825-71cb-4eba-b7b5-64b3cbf503af
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler NUVICARE LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-24
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
Pharmacologic classes 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 2027-12-31
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 Long-Acting Cough Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090487 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84324-037-01 Nuvicare Long-Acting Cough Relief 60 in 1 BOTTLE CAPSULE, LIQUID FILLED 60 2
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 97 of 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84324-037-01 84324003701 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-037-01) 2026-03-24 No No Current