Home NDC 0904-5764-12 Major Night Time Multi Symptom
Product NDC 0904-5764
Requested package NDC 0904-5764-12
11-digit product format 009045764
Labeler code 0904
Product ID 0904-5764_155e666d-117a-4e58-a425-8a1008c5bbe7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Major Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-03-01
Marketing end 2023-10-28
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0904-5764-12 00904576412 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5764-12) 2012-03-01 2023-10-28 No No Current