Home NDC 0363-9892 COLD and FLU
Product NDC 0363-9892
11-digit product format 003639892
Labeler code 0363
Product ID 0363-9892_b5f94f28-581b-cd21-e053-2a95a90a67ec
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Walgreens
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-15
Marketing end 0000-00-00
Substance ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-9892-24 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-9892-24 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-9892-24 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-9892-24 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-9892-24 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-9892-24 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-9892-24 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-9892-24 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-9892-24 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-9892-24 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0363-9892-24 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0363-9892-24 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-9892-24 00363989224 2 BLISTER PACK in 1 CARTON (0363-9892-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2017-12-15 0000-00-00 No No Current