Home NDC 55315-471-24 Night Time Cold and Flu Relief
Product NDC 55315-471
Requested package NDC 55315-471-24
11-digit product format 553150471
Labeler code 55315
Product ID 55315-471_235ac535-42b8-4a83-b814-a82d288f111b
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Freds Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-31
Marketing end 2021-12-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325 mg/1; mg/1; mg/1
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 NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FREDS INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-471-24 55315047124 2 BLISTER PACK in 1 CARTON (55315-471-24) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2015-10-31 2021-12-30 No No Current