Home NDC 55315-357-31 COLD and FLU Nighttime Relief
Product NDC 55315-357
Requested package NDC 55315-357-31
11-digit product format 553150357
Labeler code 55315
Product ID 55315-357_c1e0a501-8d63-490c-a3c3-b31baa57cd07
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
Dosage form SOLUTION
Route ORAL
Labeler Fred's, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-24
Marketing end 2021-10-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 650 mg/30mL; mg/30mL; mg/30mL
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 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 ANISE INACTIVE INGREDIENT 21C2F5E8RE COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 POLYETHYLENE GLYCOL 1500 INACTIVE INGREDIENT 1212Z7S33A COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-357-31 55315035731 2 BOTTLE in 1 CARTON (55315-357-31) > 355 mL in 1 BOTTLE 2 bottle 2015-08-24 2021-10-01 No No Current