FDA.reportPublic FDA data

NDC 0280-8292 - ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0280-8292
Manufacturer
Bayer HealthCare LLC.
Effective date
2026-04-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALKA SELTZER COLD Cold and Flu Severe Fast Dissolve Day - Bayer HealthCare LLC.Bayer HealthCare LLC.2026-04-27HUMAN OTC DRUG LABEL

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 277 of 325 · 6,482 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack96173ce4-4836-43ae-9797-5246f830643a2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3791abd3-fcdf-4c8d-b46d-db6e5c8057702024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack0c85d1b8-ea42-421d-a305-4d338b47150f2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBryant Ranch Prepack77fb237f-28b5-486b-b9ef-cb324d5cc0bd2024-05-30WarningsExact identifier
unii: 362O9ITL9D
Gas Relief Ultra StrengthSIMETHICONEA-S Medication Solutions708cbbf2-4923-4cbf-b71c-c8bb2ce80e632024-05-29WarningsExact identifier
unii: 92RU3N3Y1O
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEA-S Medication Solutionsd012ed1d-b256-48ec-b988-f226c2c5ae9e2024-05-29WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBryant Ranch Prepackb5053cf5-209d-4106-afc2-cf9af85f4a692024-05-29WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack71b1a9be-3231-4b09-a195-d5893104bd4a2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf129bc0e-1ef1-42a8-8668-2ee88ffc85e32024-05-23WarningsExact identifier
unii: 362O9ITL9D
Good Neighbor Pharmacy Childrens Pain and FeverACETAMINOPHENAmerisource Bergen074fdf65-f6ce-46d4-87cc-46911c01cca52024-05-23WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI1aba9b7c-8328-4a9f-8ce2-39648b2d8ae42024-05-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIfdf63308-fe7b-4613-a012-ed5e4c9f8ffe2024-05-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIe61ab02d-f932-403f-a4f7-0ca3546072232024-05-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Gas Relief Ultra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIa7961933-9d74-4c18-8050-2cc13cb6725e2024-05-23WarningsExact identifier
unii: 92RU3N3Y1O
Daytime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIe4f9a846-ab72-4508-b0c5-f7911af2f3d72024-05-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
unii: 92RU3N3Y1O
DG Health Childrens Pain and FeverACETAMINOPHENDolgencorp, LLC779cf607-245f-408a-81e8-8000c0ea4c4a2024-05-22WarningsExact identifier
unii: 362O9ITL9D
good sense pain and fever infantsACETAMINOPHENL. Perrigo Company7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb42024-05-21WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Night Time Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp2b8f83ed-1ca9-49ac-9b2a-2609b68200f92024-05-21WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen SolutionACETAMINOPHENPatrin Pharma, Inc.52ae729b-2255-420c-8db8-cabdc2b747962024-05-21WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.