Home NDC 84379-441 XL-3 Day Time
Product NDC 84379-441
11-digit product format 843790441
Labeler code 84379
Product ID 84379-441_49635108-cf29-a6d3-e063-6394a90a9df0
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Rnv LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 325; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Day Time
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL ACETAMINOPHEN 325 mg/15mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1113705 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 84379-441-06 XL-3 Day Time 177 mL in 1 BOTTLE LIQUID 177 3 84379-441-12 XL-3 Day 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 84379-441 XL-3 DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [RNV LLC] 1 Current NDC, 2 package rows 20241212_2381ff41-4584-4b38-839f-f94e733f5bf2.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 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 84379-441-06 84379044106 177 mL in 1 BOTTLE (84379-441-06) 177 ml 2024-12-01 No No Current 84379-441-12 84379044112 354 mL in 1 BOTTLE (84379-441-12) 354 ml 2024-12-01 No No Current