Home NDC 68016-878 NIGHTTIME COLD AND FLU RELIEF
Product NDC 68016-878
11-digit product format 680160878
Labeler code 68016
Product ID 68016-878_154cdb7a-60b0-4e36-9b1d-c579f7bf1a0d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
Dosage form CAPSULE
Route ORAL
Labeler Chain Drug Consortium, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-12
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 2026-12-31
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 2026-12-31 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 68016-878-16 NIGHTTIME COLD AND FLU RELIEF 8 in 1 CARTON CAPSULE 8 3 68016-878-16 NIGHTTIME COLD AND FLU RELIEF 2 in 1 BLISTER PACK CAPSULE 2 3 68016-878-24 NIGHTTIME COLD AND FLU RELIEF 2 in 1 BLISTER PACK CAPSULE 2 3 68016-878-24 NIGHTTIME COLD AND FLU RELIEF 12 in 1 CARTON CAPSULE 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-878 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) CAPSULE [CHAIN DRUG CONSORTIUM, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20241025_1deb60f3-e9be-4756-b0c1-527ef00dc741.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 Marketing end Sample Exclude flag Status 68016-878-16 68016087816 8 BLISTER PACK in 1 CARTON (68016-878-16) / 2 CAPSULE in 1 BLISTER PACK 8 blister pack 2019-07-12 0000-00-00 No No Current 68016-878-24 68016087824 12 BLISTER PACK in 1 CARTON (68016-878-24) / 2 CAPSULE in 1 BLISTER PACK 12 blister pack 2019-07-12 0000-00-00 No No Current