Home NDC 0280-0922 Alka-Seltzer Plus Night Severe Cold and Flu
Product NDC 0280-0922
11-digit product format 002800922
Labeler code 0280
Product ID 0280-0922_47e3298a-8540-598c-e063-6294a90ada28
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-17
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 12.5; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Alka-Seltzer Plus Night Severe Cold and Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 DOXYLAMINE SUCCINATE 12.5 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1534835 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-0922-06 Alka-Seltzer Plus Night Severe Cold and Flu 1 in 1 PACKET POWDER, FOR SOLUTION 1 10 0280-0922-06 Alka-Seltzer Plus Night Severe Cold and Flu 6 in 1 CARTON POWDER, FOR SOLUTION 6 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 TARTARIC ACID INACTIVE INGREDIENT W4888I119H ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE CONSUMER CARE] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0922 ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] 9 Current NDC, Legacy NDC, 2 package rows 20240111_f4c60ca1-ba59-4a92-84a5-6ba65faa56ab.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 76 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB SF Honey Lemon Cough Drops MENTHOL HEB d09ed4bb-7595-5e54-e053-2a95a90aa109 2025-12-13 Warnings Exact identifier application number: M012 HEB Cherry Cough Drops MENTHOL HEB c198e3c7-5ba7-ece6-e053-2995a90adb38 2025-12-13 Warnings Exact identifier application number: M012 HEB Honey Lemon Cough Drops MENTHOL HEB c19a79bc-9872-2e87-e053-2a95a90a9427 2025-12-13 Warnings Exact identifier application number: M012 Cold and Flu Daytime Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL WALMART INC. 26f55169-4b37-4a36-88ee-064d6e962065 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL Walgreen Company 39ce76a3-b7a8-43be-9b61-5c1446cd9e90 2025-12-12 Warnings Exact identifier application number: M012 Cold and Flu maximum strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Rite Aid Corporation ac01206f-a717-4c0b-8a03-fab0a4fd154b 2025-12-12 Warnings Exact identifier application number: M012 Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Strategic Sourcing Services LLC dcb80dd5-465d-4792-947a-3044e25a5284 2025-12-12 Warnings Exact identifier application number: M012 Vapor Rub COUGH SUPPRESSANT Neilmed Pharmaceuticals Inc. 39190f9f-8a5a-e4d8-e063-6294a90a57dd 2025-12-12 Warnings Exact identifier application number: M012 Medicated Chest Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL Cardinal Health, 110 dba LEADER b7393668-1450-4e85-9793-d400daf39b43 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief, 24-7 Life by 7-Eleven DIPHENHYDRAMINE HCL TABLET, FILM COATED Lil' Drug Store Products, Inc. 45c4cd6c-327d-5950-e063-6394a90a3a21 2025-12-12 Warnings Exact identifier application number: M012 Menthol cough drops MENTHOL Family Dollar 44bb3b95-b2ba-470e-e054-00144ff88e88 2025-12-12 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Family Dollar 44bb9c7b-994b-4ab8-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44be9837-f15a-09f2-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44bcae39-2389-09ee-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 46635813-66c4-504c-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 455b0f4b-0526-2361-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 Family Wellness Strawberry Cough Drops MENTHOL Family Dollar f92466ac-dd93-9ac5-e053-6294a90a9291 2025-12-12 Warnings Exact identifier application number: M012 GoodSense Menthol Cough Drops MENTHOL Geiss, Destin, Dunn c6b25d69-8930-6867-e053-2a95a90ad208 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Cough Drops MENTHOL Geiss, Destin, Dunn c72db7f0-9324-8ed2-e053-2995a90a9868 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Honey Lemon Cough Drops MENTHOL Geiss, Destin, Dunn c72e557f-0211-81b9-e053-2995a90a1437 2025-12-12 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0922-06 00280092206 6 PACKET in 1 CARTON (0280-0922-06) > 1 POWDER, FOR SOLUTION in 1 PACKET 6 packet 2014-04-17 0000-00-00 No No Current