Home NDC 84379-444 XL-3 Night Time
Product NDC 84379-444
11-digit product format 843790444
Labeler code 84379
Product ID 84379-444_49634dc2-a45b-f42b-e063-6294a90ade9c
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler Rnv LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 12.5; 650; 30 mg/30mL; mg/30mL; mg/30mL
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 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 XL-3 Night Time
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 12.5 mg/30mL ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9BI9B5YI2 Internal UNII lookup 362O9ITL9D Internal UNII lookup 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 1043400 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 84379-444-06 XL-3 Night Time 177 mL in 1 BOTTLE LIQUID 177 3 84379-444-12 XL-3 Night Time 354 mL in 1 BOTTLE LIQUID 354 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84379-444 XL-3 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [RNV LLC] 1 Current NDC, 2 package rows 20241212_03210929-331e-462d-b566-4e1865f52246.zip
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 73 of 177 · 3,534 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 84379-444-06 84379044406 177 mL in 1 BOTTLE (84379-444-06) 177 ml 2024-12-01 No No Current 84379-444-12 84379044412 354 mL in 1 BOTTLE (84379-444-12) 354 ml 2024-12-01 No No Current