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 55 of 274 · 5,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONEWalgreens52cceb6b-f2c8-49bf-b5ce-5d1c999a9b602026-04-17WarningsExact identifier
unii: 92RU3N3Y1O
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
unii: R16CO5Y76E
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC4f97d398-2118-0874-e063-6394a90a4ad12026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
application number: M012
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
unii: R16CO5Y76E
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
unii: 92RU3N3Y1O
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Childrens Daytime MucusDEXTROMETHORPHAN HBRWalgreens7a55b7e1-1054-421e-847e-5e4d90d1aebb2026-04-15WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Childrens Nighttime MucusDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreensdc69f581-27c7-4030-bb18-39685c7691a12026-04-15WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
application number: M012
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)6d454e89-59ce-40dc-b0d2-3330a7df519f2026-04-15WarningsExact identifier
unii: 9D2RTI9KYH
nighttime sleep aidDOXYLAMINE SUCCINATEHyVee Inc95b12a14-21ee-431d-a892-46f8cdca2d7a2026-04-15WarningsExact identifier
unii: V9BI9B5YI2

Reported adverse events (FAERS/openFDA)#

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