Childrens Aurotussin Cough and Cold CF

Product NDC
58602-154
11-digit product format
586020154
Labeler code
58602
Product ID
58602-154_23752d3d-525a-4a59-a0da-8a1aeff184be
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
Dosage form
LIQUID
Route
ORAL
Labeler
Aurohealth LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-30
Marketing end
2022-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/10mL; mg/10mL; mg/10mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58602-154DDiscontinued by firm2026-10-12
excluded packagepackage58602-15458602-154-24DDiscontinued by firm2026-10-12

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 · 24 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 packagepackage58602-154-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-154-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-154-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-154-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-154-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-154-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-154-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-154-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-154-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-154-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-154-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-154-24557ba5c1ecfa…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 INGREDIENT9D2RTI9KYHCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
GRAPEINACTIVE INGREDIENT6X543N684KCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS AUROTUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-154-24586020154241 BOTTLE in 1 CARTON (58602-154-24) > 118 mL in 1 BOTTLE1 bottle2015-06-302022-04-01NoNoCurrent