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 184 of 332 · 6,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Maximum Strength Antacid and AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEMeijer, Inc.30a0455d-63e0-95cc-e063-6394a90ada6b2025-07-30WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
unii: 92RU3N3Y1O
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad21a3-6229-e91b-e063-6394a90a79332025-07-29WarningsExact identifier
unii: 362O9ITL9D
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackfa88d7b2-6c8e-4893-bd81-ecd4f2aca4932025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
unii: 362O9ITL9D
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
unii: 362O9ITL9D
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBetter Living Brands LLCdca1d482-062f-4915-b0a7-c00ab47aaff82025-07-25WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM MAXIMUM STRENGTHGUAIFENESIN AND DEXTROMETHORPHAN HBRBetter Living Brands LLC4ee69f46-3dc6-4249-9b04-186fa0a13e842025-07-25WarningsExact identifier
unii: 9D2RTI9KYH
Anti-Diarrheal/Anti-Gas CapletsLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGYYBA CORP46f5c653-eec2-4729-8aaa-79f2e188eac32025-07-24WarningsExact identifier
unii: 92RU3N3Y1O
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
unii: 92RU3N3Y1O
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
unii: 362O9ITL9D
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
unii: 362O9ITL9D
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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