Home NDC 58602-128-20 Aurophen Cold Multi-Symptom Severe
Product NDC 58602-128
Requested package NDC 58602-128-20
11-digit product format 586020128
Labeler code 58602
Product ID 58602-128_b77d859c-4783-4b70-8f1c-6661c6d8fb67
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Aurohealth LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-04-30
Marketing end 2022-06-22
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/15mL; 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 AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [AUROHEALTH LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUROPHEN COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [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 58602-128-20 58602012820 1 BOTTLE in 1 CARTON (58602-128-20) > 240 mL in 1 BOTTLE 1 bottle 2015-04-30 2022-06-22 No No Current