Home NDC 68016-879 COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF
Product NDC 68016-879
11-digit product format 680160879
Labeler code 68016
Product ID 68016-879_007a5e30-3aae-4929-8fa3-e9b2ec6f2edd
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate
Dosage form KIT
Labeler Chain Drug Consortium, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-12
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 COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086997 Internal RxNorm lookup 1094549 Internal RxNorm lookup 2634564 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 68016-879-48 COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF 1 in 1 PACKAGE KIT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-879 COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) KIT [CHAIN DRUG CONSORTIUM, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241025_f9c3c12b-4efa-4ec4-a156-c403aff81753.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 98 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 68016-879-48 68016087948 1 KIT in 1 PACKAGE (68016-879-48) * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK 1 kit 2019-07-12 0000-00-00 No No Current