AuroQuil Cough Nighttime Cough Relief

Product NDC
58602-132
11-digit product format
586020132
Labeler code
58602
Product ID
58602-132_1d2798d1-0637-4364-8c0f-f3d6ab1f7248
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Doxylamine succinate
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
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30 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 productproduct58602-132DDiscontinued by firm2026-10-05
excluded packagepackage58602-13258602-132-16DDiscontinued by firm2026-10-05
excluded packagepackage58602-13258602-132-18DDiscontinued by firm2026-10-05
excluded packagepackage58602-13258602-132-20DDiscontinued 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 packagepackage58602-132-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-132-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-132-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-132-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-132-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-132-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-132-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-132-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-132-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-132-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-132-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-132-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-132-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-132-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-132-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-132-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-132-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-132-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-132-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-132-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-132-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-132-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-132-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-132-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-132-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-132-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-132-180efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-132-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-132-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-132-18ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-132-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-132-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-132-18367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-132-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-132-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-132-18557ba5c1ecfa…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
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2AUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
CHERRYINACTIVE INGREDIENTBUC5I9595WAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RAUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-132-1658602013216354 mL in 1 BOTTLE (58602-132-16) 354 ml2015-07-272021-09-01NoNoCurrent
58602-132-1858602013218236 mL in 1 BOTTLE (58602-132-18) 236 ml2015-07-272021-09-01NoNoCurrent
58602-132-2058602013220177 mL in 1 BOTTLE (58602-132-20) 177 ml2015-07-272021-09-01NoNoCurrent