Home NDC 0280-0924 Alka-Seltzer Plus Day and Night Severe Cold and Flu
Product NDC 0280-0924
11-digit product format 002800924
Labeler code 0280
Product ID 0280-0924_d917f41e-20da-51a2-e053-2995a90a187f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate
Dosage form KIT
Labeler Bayer HealthCare LLC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-07-01
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2023-12-31
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 · 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-0924-12 Alka-Seltzer Plus Day and Night Severe Cold and Flu 1 in 1 CARTON KIT 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 TARTARIC ACID INACTIVE INGREDIENT W4888I119H ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0924 ALKA-SELTZER PLUS DAY AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE LLC.] 8 Legacy NDC, 1 package rows 20240111_c7a4e6ad-7315-47bf-ae91-cc511da73734.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1804384 {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution) } Pack GPCK c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1804384 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Packet for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Packet for Oral Solution) Pack PSN c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1550968 acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Powder for Oral Solution PSN c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1534835 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution PSN c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1550968 acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution SCD c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1534835 acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution SCD c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1804384 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG Packet for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Packet for Oral Solution) Pack SY c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1550968 acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Granules for Oral Solution SY c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1534835 acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution SY c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1550968 APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 400 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution SY c7a4e6ad-7315-47bf-ae91-cc511da73734 8 1534835 APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution SY c7a4e6ad-7315-47bf-ae91-cc511da73734 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0924-12 00280092412 1 KIT in 1 CARTON (0280-0924-12) * 1 POWDER, FOR SOLUTION in 1 PACKET * 1 POWDER, FOR SOLUTION in 1 PACKET 1 kit 2014-07-01 0000-00-00 No No Current