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 216 of 331 · 6,610 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company5ddf3283-94e4-465d-842a-471ee946c3302025-01-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Vicks VapoSteamCAMPHOR (SYNTHETIC)Kaz USA, Incc28da455-07ad-4053-8b9e-fc559f9a3f722025-01-10WarningsExact identifier
application number: M012
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 8MDF5V39QO
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAvPAKe5fbd6b8-85e7-8847-e053-2a95a90a52ed2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Guaifenesin 200mgGUAIFENESINAphena Pharma Solutions - Tennessee, LLC45ac210a-8c54-4469-8e10-e6fe52b89cb52025-01-09WarningsExact identifier
application number: M012
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
Anti-Gas StripSIMETHICONECalmourc1576ee9-69ff-41ff-b2d0-7703c8fa8edd2025-01-09WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Diarrheal/Anti-Gas Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGWal-Mart Stores, Inc.a4d5dd69-22cf-4d00-b539-133886c09e372025-01-09WarningsExact identifier
unii: 92RU3N3Y1O
AcetaminophenACETAMINOPHENMajor Pharmaceuticals32ea1230-f9ae-46b0-910e-05cd187cee342025-01-09WarningsExact identifier
unii: 362O9ITL9D
Caring Mill Bug Bite Relief WipesCARING MILL BUG BITE RELIEF WIPESShenzhen Shierjie Biological Engineering Co., LTD2a373589-aec3-b294-e063-6394a90a39f12025-01-08WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9545d58c-1c49-79b3-e053-2995a90a9d402025-01-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
7.5% SODIUM BICARBONATE7.5% SODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9d4bbd21-f59c-7e9c-e053-2a95a90a08262025-01-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
SimethiconeSIMETHICONEAMZ789 LLCbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa22025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 250mgSIMETHICONE 250MGAMZ789 LLCfcc2ef8b-9181-2c59-e053-6394a90adcc12025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEAphena Pharma Solutions - Tennessee, LLCd53bf9b7-1652-4287-a0c1-e89f6f0cb7f12025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
extra strength Gas Relief cherry cremeSIMETHICONEAmerisource Bergen1e8e8d85-10e2-1273-e063-6394a90a15582025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
APADAZBENZHYDROCODONE AND ACETAMINOPHENZevra Therapeutics, Inc.0590d4e5-7107-4015-a6a8-deac14265aa22025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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