Home NDC 69517-161 Night-Time Cold and Flu Relief
Product NDC 69517-161
11-digit product format 695170161
Labeler code 69517
Product ID 69517-161_0833784b-16a9-75f4-e063-6394a90a47d6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler HealthLife of USA
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-04
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 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 Night-Time Cold and Flu Relief
Listing expiration 2027-12-31 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 69517-161-10 Night-Time Cold and Flu Relief 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 2 69517-161-10 Night-Time Cold and Flu Relief 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69517-161 NIGHT-TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA] 2 Current NDC, 2 package rows 20231021_2ffd62a6-703f-4cb0-bb13-49719c004d00.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 178 · 3,551 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 69517-161-10 69517016110 1 BLISTER PACK in 1 CARTON (69517-161-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2023-04-04 No No Current