Home NDC 58602-125-16 AuroQuil COLD and FLU Day Time Multi-Symptom Relief
Product NDC 58602-125
Requested package NDC 58602-125-16
11-digit product format 586020125
Labeler code 58602
Product ID 58602-125_1d99f4fe-d024-4693-8a0d-a5d7c10de69d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl, 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; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/15mL; mg/15mL; mg/15mL
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 DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 ORANGE INACTIVE INGREDIENT 5EVU04N5QU AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, 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 58602-125-16 58602012516 354 mL in 1 BOTTLE (58602-125-16) 354 ml 2015-07-27 2021-09-01 No No Current