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 48 of 414 · 8,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS Pain and FeverACETAMINOPHENAurohealth LLCb3f57af5-661f-4534-9eed-76e431f338db2026-05-20WarningsExact identifier
unii: 362O9ITL9D
Sleep Aid NightTimeDIPHENHYDRAMINE HCLWal-Mart Stores Incdac2a0b9-f851-467b-a39f-3560d42c96e22026-05-20WarningsExact identifier
unii: TC2D6JAD40
Infants Pain and FeverACETAMINOPHENAurohealth LLCe837538d-0515-4f99-b04c-fda63b28777e2026-05-20WarningsExact identifier
unii: 362O9ITL9D
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)7af82ca5-ea36-4b72-88b8-0fe68348d2692026-05-19WarningsExact identifier
unii: TC2D6JAD40
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.61a1beb3-decf-4c8d-a402-93a02ec40a432026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Extra Strength Tylenol Cold plus Flu Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC52291746-2bbf-8f3f-e063-6294a90adcfc2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
ProlateOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLC9cbbfa94-37b9-9652-e053-2995a90a736b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 495W7451VQ
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
unii: 362O9ITL9D
unii: 495W7451VQ
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENST. MARY'S MEDICAL PARK PHARMACY3d347b9b-1b5c-68c8-e063-6294a90aaa9b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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