Home NDC 58602-136-16 AuroQuil COLD and FLU Nighttime Relief
Product NDC 58602-136
Requested package NDC 58602-136-16
11-digit product format 586020136
Labeler code 58602
Product ID 58602-136_eade5853-6ad0-4f38-9466-509fc37c16d5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
Dosage form SOLUTION
Route ORAL
Labeler Aurohealth LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-27
Marketing end 2021-09-01
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 AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 CHERRY INACTIVE INGREDIENT BUC5I9595W AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 POLYETHYLENE GLYCOL 1500 INACTIVE INGREDIENT 1212Z7S33A AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH 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 58602-136-16 58602013616 355 mL in 1 BOTTLE (58602-136-16) 355 ml 2015-07-27 2021-09-01 No No Current