FDA.reportPublic FDA data

NDC 85237-1650-03 - Mucinex DM

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
85237-1650
Requested NDC
85237-1650-03
Package NDCs from labels
85237-1650-1, 85237-1650-3, 85237-1650-03
Manufacturer
Select Consumer Group
Effective date
2026-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mucinex DM - Select Consumer GroupSelect Consumer Group2026-08-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85237-1650-1Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE22
85237-1650-2Mucinex DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
85237-1650-2Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE22

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 109 of 117 · 2,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin Syrup and DextromethorphanGUAIFENESIN SYRUP AND DEXTROMETHORPHANNatco Pharma USA LLCad9026f4-f0b6-4d02-aa44-f0460eeefc0e2023-11-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: LMI26O6933
Mineffect acid indigestion and heartburn reliefALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUMKadesh Incoporation Co,Ltd048367ff-a9bb-46a3-a835-aa3ab391eee42023-10-31WarningsExact identifier
unii: LMI26O6933
Mineffect facial skin protectant and acne treatment solutionALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, MAGNESIA SULPHURICA, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltdf6b3ea92-2382-4c3f-8ed9-31ea26fd47ee2023-10-31WarningsExact identifier
unii: LMI26O6933
Daytime Cold and Flu ReliefDAYTIME COLD AND FLU RELIEFTopCo Associates, LLCd592fbb8-d4bf-444e-982e-edf6fe97dce42023-10-31WarningsExact identifier
unii: 9D2RTI9KYH
Nite Time Cold and Flu ReliefNITE TIME COLD AND FLU RELIEFTopCo Associates, LLC407dc4ae-882d-4a49-8884-ef048bb404cf2023-10-31WarningsExact identifier
unii: 9D2RTI9KYH
Mucosa DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMagno-Humphries, Inc.3a5533fb-1c83-4b95-9cd2-9be663d3ff5f2023-10-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucosa GuifenesinGUAIFENESINMagno-Humphries, Inc.9d22c208-d0ae-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
unii: 495W7451VQ
ALKA SELTZER PLUS Cold Day and Night EffervescentASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATESincronia Logistica, S.A. de C.V.c478df69-823a-4112-8f44-323249a9f38f2023-10-23WarningsExact identifier
unii: 9D2RTI9KYH
MUCINEXGUAIFENESINA-S Medication Solutions08ea92cc-4a0f-44c9-9edf-71f67e0144312023-10-23WarningsExact identifier
unii: 495W7451VQ
ROBAFEN DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutionsd5965f49-2b89-425c-9909-c75c87f930fc2023-10-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Night-Time Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealthLife of USA2ffd62a6-703f-4cb0-bb13-49719c004d002023-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Day-Time Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHANHealthLife of USAc5f6cf22-2aaa-40e1-b7b3-448e55898d622023-10-21WarningsExact identifier
unii: 9D2RTI9KYH
PENTREXCILINAACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEHealthlife of USAae9ada14-0ec8-4c01-a874-237f2108936a2023-10-21WarningsExact identifier
unii: 9D2RTI9KYH
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
unii: 495W7451VQ
AluminaALUMINUM OXIDEBoiron84266aa8-b80c-a2a5-e053-2991aa0a68e02023-10-18Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron8426b2bb-4401-9015-e053-2991aa0a09932023-10-18Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron8426e977-2b24-fdf4-e053-2a91aa0a7c392023-10-18Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron84b528ab-23f7-e42c-e053-2991aa0acc4d2023-10-18Exact identifier
unii: LMI26O6933
Mucinex DM, TRAVEL BASIXGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.c274b05c-8f05-4980-9a93-77affb322e572023-10-10WarningsExact identifier
application number: NDA021620
rxcui: 1298324
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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