FDA.reportPublic FDA data

NDC 41250-591 - Severe Cough and Congestion and Cold and Flu Daytime, Nighttime

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
41250-591
Package NDCs from labels
41250-591-03
Manufacturer
Meijer Distribution Inc | LNK International, Inc.
Effective date
2025-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Meijer 44-648694 DelistedMeijer Distribution Inc | LNK International, Inc.2025-09-02HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-591SEVERE COUGH AND CONGESTION AND COLD AND FLU DAYTIME, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC]2Unmatched20250110_32ce39a6-2eb6-4792-ba94-580175f49385.zip

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 208 of 408 · 8,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLFOODHOLD U.S.A., LLCfdd7ce80-d6be-41b9-affd-d024cf306b502025-09-12WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
Sleep AidDIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)485ce8ae-c2b7-462f-9c08-8594cd121f0c2025-09-11WarningsExact identifier
unii: TC2D6JAD40
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.3e89240b-0e27-fde4-e063-6394a90a779f2025-09-11WarningsExact identifier
unii: 362O9ITL9D
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
unii: TC2D6JAD40
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
unii: 495W7451VQ
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka200d099-fa55-4ef1-b8d7-936a7da1db002025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
unii: 15FIX9V2JP
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Medi First Plus PMS ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEUnifirst First Aid Corporatione84007e7-498d-4662-e053-2995a90ad4de2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Travel Savvy Non-AspirinACETAMINOPHEN 325MGBellegrove Medical Supply, Inc.6ab08633-5d5a-42b2-e053-2991aa0ab41a2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Direct Safety Aspirin FreeACETAMINOPHENConney Safety Products, LLC1c7369ea-46b6-407c-aa4b-048eb72ff03f2025-09-09WarningsExact identifier
unii: 362O9ITL9D
Direct Safety Extra Strength Aspirin FreeACETAMINOPHENConney Safety Products, LLCa524c36a-38f3-4266-8f45-589e194003282025-09-09WarningsExact identifier
unii: 362O9ITL9D
McKesson Acetaminophen 325ACETAMINOPHENMcKesson Medical-Surgical, Inc.bc2daba5-ce8b-bbda-e053-2a95a90a6f332025-09-09WarningsExact identifier
unii: 362O9ITL9D
Uline Acetaminophen Extra StrengthACETAMINOPHENUline90167594-0a49-2492-e053-2a95a90a14012025-09-09WarningsExact identifier
unii: 362O9ITL9D
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
Rompe Pecho CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLEfficient Laboratories Inc96c4dee1-6e66-4442-a7e3-56e874414c172025-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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