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 110 of 117 · 2,329 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Triacting Daytime Cold Cough ChildrensDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8656aa2e-9546-4de4-9ecc-ce99bf9033332023-10-10WarningsExact identifier
unii: 9D2RTI9KYH
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)553d01a9-e8ad-4797-b55b-32f134f08af92023-10-10WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)93a5cb36-3262-4224-a5be-5ea1619a67bd2023-10-10WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINCVS Pharmacy782fb103-cd9f-4e8c-8f3a-1fb131b9eda62023-10-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
dg health mucus er maxGUAIFENESINDolgencorp Incea8deeb0-d6c0-4cb6-b599-ca938ea223972023-10-05WarningsExact identifier
unii: 495W7451VQ
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.ac8c0c15-b305-47f2-8712-e4b53636f7fa2023-10-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIe7d457a6-05f9-407c-bf9b-a82e3cf2568c2023-09-07WarningsExact identifier
unii: 495W7451VQ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack51c95c28-8979-4b75-b1d6-8568751065872023-08-16Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Promethazine Hydrochloride and Dextromethorphan Hydrobromide OralPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORALA-S Medication Solutions9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252023-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
equaline mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFI1db69578-2331-4fce-91a4-95c54cb7dc072023-08-07WarningsExact identifier
rxcui: 1298324
unii: 9D2RTI9KYH
unii: 495W7451VQ
Equaline Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI04334889-f75e-4a19-a8b4-47b8db18b9aa2023-08-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions104b29ed-a377-4436-8e24-413c63579f2e2023-07-27WarningsExact identifier
application number: NDA021620
unii: 9D2RTI9KYH
unii: 495W7451VQ
equaline cough dmDEXTROMETHORPHAN POLISTIREXUnited Natural Foods, Inc. dba UNFI16de32bb-1d02-470b-82b6-9b4366e198172023-07-24WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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