Home NDC 80513-304 NIGHTTIME COLD AND FLU RELIEF
Product NDC 80513-304
11-digit product format 805130304
Labeler code 80513
Product ID 80513-304_14ddc061-b1ab-5f66-e063-6394a90af806
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Advanced Rx LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Active strength 15; 6.25; 325 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 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 NIGHTTIME COLD AND FLU RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 ACETAMINOPHEN 325 mg/1
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 V9BI9B5YI2 Internal UNII lookup 362O9ITL9D 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 80513-304-50 NIGHTTIME COLD AND FLU RELIEF 50 in 1 BOTTLE CAPSULE, LIQUID FILLED 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-304 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ADVANCED RX LLC] 1 Current NDC, 1 package rows 20240404_d1542362-19c5-4470-89e8-87d26e2ca8ed.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 Marketing start Sample Exclude flag Status 80513-304-50 80513030450 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-304-50) 2024-03-01 No No Current