Home NDC 68016-599-16 Nighttime Cold and flu Relief
Product NDC 68016-599
Requested package NDC 68016-599-16
11-digit product format 680160599
Labeler code 68016
Product ID 68016-599_943b78e2-32cb-5557-7a7a-7f2b14545aad
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate,
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-12
Marketing end 2021-07-31
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-599-16 68016059916 8 CARTON in 1 BLISTER PACK (68016-599-16) > 2 CAPSULE, LIQUID FILLED in 1 CARTON 8 carton 2015-10-12 2021-07-31 No No Current