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 75 of 274 · 5,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Pain Reliever / Low Dose AspirinASPIRINPHARMAMED USA INC1a3ff0da-85eb-542c-e063-6294a90a9cca2026-02-12WarningsExact identifier
unii: R16CO5Y76E
ASPIRIN Low StrengthASPIRINCVS Pharmacy6e1c1129-562b-4a8a-ac37-db3cb2a827352026-02-11WarningsExact identifier
unii: R16CO5Y76E
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions511a5d9b-16a6-481c-a3d3-bcba911ecc9d2026-02-11WarningsExact identifier
unii: 9D2RTI9KYH
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
unii: R16CO5Y76E
Sleep AidDOXYLAMINE SUCCINATEWalgreen Companyd812217b-b2f2-4716-92f4-c16bd0768e172026-02-11WarningsExact identifier
unii: V9BI9B5YI2
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC869e950c-5861-4840-aaad-b0342790d62b2026-02-10WarningsExact identifier
application number: M012
CareOne Night TIme Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de252026-02-10WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRRugby Laboratories69cd399a-0103-4543-bb06-c7cccffe9cc42026-02-10WarningsExact identifier
unii: 9D2RTI9KYH
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Sportpharm LLCd61df3a4-8ae2-46b1-b322-7f4e04cc1bf92026-02-09WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Sinus Congestion and Pain DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIf3fc270a-92fc-46d5-b187-44e875c3abb92026-02-09WarningsExact identifier
application number: M012
Ascomp with CodeineBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEBreckenridge Pharmaceutical, Inc.243a6aea-0f48-42a9-a85e-ff247ab943362026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R16CO5Y76E
SODIUM BICARBONATESODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedba92f45a-0187-4709-aa70-462b8dae09e92026-02-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incd07112dd-27df-46cc-b7c3-af8ba7601d062026-02-09WarningsExact identifier
application number: M012
good sense aspirinASPIRINL. Perrigo Companye9fddbc1-11fe-4cf6-8794-1650fa1b32ae2026-02-07WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINChain Drug Marketing Association, Inc.2d375ec9-a528-4048-a15b-652fa20e74a72026-02-06WarningsExact identifier
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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