FDA.reportPublic FDA data

NDC 00280-0020 - Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night

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
00280-0020
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy - Bayer HealthCare LLC.Bayer HealthCare LLC.2025-12-04HUMAN 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 26 of 276 · 5,511 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
unii: R16CO5Y76E
Nighttime Sleep AidDOXYLAMINE SUCCINATEH E B17667c28-b61e-4974-8736-5de59f69b3b02026-07-09WarningsExact identifier
unii: V9BI9B5YI2
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
unii: 27O3Q5ML57
unii: R16CO5Y76E
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
unii: 92RU3N3Y1O
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Sleep-AidDOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leader96e8d6df-e717-4ffc-9502-498024c9665f2026-07-09WarningsExact identifier
unii: V9BI9B5YI2
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
unii: R16CO5Y76E
Nocto Sleep AidDOXYLAMINE SUCCINATEBelmora LLCd255309b-0023-48fe-890f-6a4fe04dbb852026-07-09WarningsExact identifier
unii: V9BI9B5YI2
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
unii: R16CO5Y76E
Dextromethorphan Hydrobromide and Quinidine SulphateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATESun Pharmaceutical Industries, Inc.92b54ac4-594e-47b8-a4d3-394a29b425f32026-07-08Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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