FDA.reportPublic FDA data

NDC 63824-072-45 - Mucinex DM Maximum Strength

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
63824-072
Requested NDC
63824-072-45
Package NDCs from labels
63824-072-07, 63824-072-35, 63824-072-36, 63824-072-46, 63824-072-48, 63824-072-18, 63824-072-56, 63824-072-02, 63824-072-45
Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mucinex DM Maximum Strength - Reckitt Benckiser LLCReckitt Benckiser LLC2026-05-27HUMAN OTC DRUG LABEL
Mucinex DM Maximum Strength - A-S Medication SolutionsA-S Medication Solutions2023-07-27HUMAN OTC DRUG LABEL
Mucinex DM Maximum Strength - A-S Medication SolutionsA-S Medication Solutions2021-02-23HUMAN OTC DRUG LABEL
Mucinex®DMPhysicians Total Care, Inc.2009-12-23HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-072-02Mucinex DMMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-072-02Mucinex DMMaximum Strength1 in 1 POUCHTABLET, EXTENDED RELEASE118
63824-072-07Mucinex DMMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-072-07Mucinex DMMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE718
63824-072-18Mucinex DMMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-072-18Mucinex DMMaximum Strength9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE918
63824-072-35Mucinex DMMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-072-35Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418
63824-072-36Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418
63824-072-36Mucinex DMMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-072-46Mucinex DMMaximum Strength3 in 1 CARTONTABLET, EXTENDED RELEASE318
63824-072-46Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418
63824-072-48Mucinex DMMaximum Strength4 in 1 CARTONTABLET, EXTENDED RELEASE418
63824-072-48Mucinex DMMaximum Strength12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1218
63824-072-56Mucinex DMMaximum Strength4 in 1 CARTONTABLET, EXTENDED RELEASE418
63824-072-56Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-072MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]17Current NDC, Legacy NDC, 16 package rows20250410_588eddc1-fa30-41cc-8ed9-c01319ea21c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-072-07EA - Each63824-0721a92612a-1867-48de-b636-76856e8a4eff12015-08-04
63824-072-18EA - Each63824-07237cc9afa-3a15-4710-9860-34e75bb1126812021-05-05
63824-072-35EA - Each63824-072ece4c5f8-5fd4-446a-acd5-58bfee9cd56a12012-07-24
63824-072-36EA - Each63824-0729cc6f6f8-37c5-4a46-b3d1-cb9f284b194312012-07-24
63824-072-45EA - Each63824-07262ba5fca-2281-40b6-8e33-b5ff0e5489e412012-07-24
63824-072-46EA - Each63824-072ed63d0ad-77d3-4ecc-a20e-acb1f577dd7512012-07-24
63824-072-48EA - Each63824-0726d7befc8-f5c3-4f32-9d9f-8b9dfc191aab12012-07-24
63824-072-56EA - Each63824-0727cacc7e0-d118-471c-bba3-9e1bc8c67c3412021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
DextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

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 1 of 118 · 2,359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 495W7451VQ
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 9D2RTI9KYH
12 hr relief cough dmDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED03c44e2f-d6e3-4c78-9c9a-92d1708a62fe2026-09-16WarningsExact identifier
unii: 9D2RTI9KYH
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: 9D2RTI9KYH
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 9D2RTI9KYH
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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