AuroQuil COLD and FLU Nighttime Relief

Product NDC
58602-136
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58602-136DDiscontinued by firm2026-10-05
excluded packagepackage58602-13658602-136-16DDiscontinued by firm2026-10-05
excluded packagepackage58602-13658602-136-18DDiscontinued by firm2026-10-05
excluded packagepackage58602-13658602-136-20DDiscontinued by firm2026-10-05

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-136-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-136-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-136-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-136-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-136-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-136-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-136-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-136-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-136-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-136-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-136-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-136-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-136-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-136-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-136-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-136-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-136-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-136-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-136-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-136-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-136-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-136-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-136-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-136-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-136-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-136-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-136-180efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-136-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-136-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-136-18ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-136-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-136-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-136-18367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-136-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-136-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-136-18557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
CHERRYINACTIVE INGREDIENTBUC5I9595WAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RAUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-136-1658602013616355 mL in 1 BOTTLE (58602-136-16) 355 ml2015-07-272021-09-01NoNoCurrent
58602-136-1858602013618177 mL in 1 BOTTLE (58602-136-18) 177 ml2015-07-272021-09-01NoNoCurrent
58602-136-2058602013620237 mL in 1 BOTTLE (58602-136-20) 237 ml2015-07-272021-09-01NoNoCurrent