AuroMucus - Fast Maximum Severe Congestion and Cough

Product NDC
58602-112
11-digit product format
586020112
Labeler code
58602
Product ID
58602-112_5dfba765-9654-455e-82c9-94c9655157e1
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurohealth LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-18
Marketing end
2022-06-22
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/20mL; mg/20mL; mg/20mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58602-112DDiscontinued by firm2026-10-16
excluded packagepackage58602-11258602-112-18DDiscontinued by firm2026-10-16
excluded packagepackage58602-11258602-112-21DDiscontinued by firm2026-10-16

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 · 36 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 packagepackage58602-112-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-112-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-112-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-112-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-112-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-112-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-112-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-112-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-112-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-112-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-112-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-112-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-112-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-112-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-112-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-112-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-112-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-112-180efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-112-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-112-18ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-112-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-112-18367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-112-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-112-18557ba5c1ecfa…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 INGREDIENT9D2RTI9KYHAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
BERRYINACTIVE INGREDIENTFV3431923ZAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-112-1858602011218177 mL in 1 BOTTLE (58602-112-18) 177 ml2015-07-182022-06-22NoNoCurrent
58602-112-2158602011221266 mL in 1 BOTTLE (58602-112-21) 266 ml2015-07-182022-06-22NoNoCurrent