Home NDC 68016-710-12 COLD and FLU Nighttime Relief
Product NDC 68016-710
Requested package NDC 68016-710-12
11-digit product format 680160710
Labeler code 68016
Product ID 68016-710_82b9be04-2d9d-478c-828e-6ea0a819e37e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
Dosage form SOLUTION
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-27
Marketing end 2021-10-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 650 mg/30mL; mg/30mL; mg/30mL
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 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 ANISE INACTIVE INGREDIENT 21C2F5E8RE COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 POLYETHYLENE GLYCOL 1500 INACTIVE INGREDIENT 1212Z7S33A COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [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 68016-710-12 68016071012 355 mL in 1 BOTTLE (68016-710-12) 355 ml 2015-07-27 2021-10-01 No No Current