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 199 of 408 · 8,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
unii: 04JA59TNSJ
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsExact identifier
unii: TC2D6JAD40
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsExact identifier
unii: TC2D6JAD40
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
unii: 495W7451VQ
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyfa33f6ef-522b-4630-9716-92371d9cd24a2025-10-14WarningsExact identifier
unii: 362O9ITL9D
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
TexaClear Pain and Chest Congestion ReliefCHOLINE SALICYLATE,GUAIFENESINGM Pharmaceuticals, INC672bc78a-2c71-4135-b64a-2b8c40ac688c2025-10-13WarningsExact identifier
unii: 495W7451VQ
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD41157552-2473-176b-e063-6294a90a9ad02025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd4115d122-3090-d3e5-e063-6294a90aafb62025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWal-mart Stores, Inc.f3933531-aa4d-cb67-1895-f2f14175f1d22025-10-10WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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