FDA.reportPublic FDA data

NDC 85237-1650-01 - 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
85237-1650-01
Package NDCs from labels
85237-1650-1, 85237-1650-3, 85237-1650-01
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 112 of 118 · 2,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
AluminaALUMINUM OXIDEBoiron84b4fd05-f2cc-3b45-e053-2991aa0ad5d92023-07-11Exact identifier
unii: LMI26O6933
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
AluminaALUMINAHahnemann Laboratories, INC.ffdbdb70-8666-f0c6-e053-6394a90a65962023-07-06Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoirona9603cb0-7c3b-11e6-8197-424c583030312023-06-26Exact identifier
unii: LMI26O6933
signature care 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXSafeway6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a82023-06-08WarningsExact identifier
unii: 9D2RTI9KYH
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions440d0554-995c-47df-b9f6-f3e3ce2e35e02023-06-06Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAARNA USA, Inc.6e488782-0138-436d-a9f0-0ec5bc9daedd2023-05-15WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)ee34af0f-61ba-49fa-81e0-20da4c5823682023-05-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus ReliefGUAIFENESINFSA STORE INC.f524479a-2c15-50d9-e053-2995a90a805e2023-05-03WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC3578086b-f961-4494-9bbd-5305320487272023-04-21WarningsExact identifier
unii: 495W7451VQ
AluminaALUMINUM OXIDEBoiron8426bd35-372c-4417-e053-2a91aa0a79032023-04-11Exact identifier
unii: LMI26O6933
Mucus ReliefGUAIFENESINWINCO FOODS, LLCf45f43da-b992-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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