FDA.reportPublic FDA data

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu ExpressMax Severe Cold and Flu CapletsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC8e22f6bc-33ce-4bb0-99be-7947aa21f60e2024-03-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Theraflu ExpressMax Severe Cold and Flu SyrupACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC777d2ac7-e3cc-4513-8b6f-b90b2ff2c6722024-03-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacy423fd5e6-5d90-4539-81e0-0ae23881ee3a2024-03-07WarningsExact identifier
unii: 9D2RTI9KYH
Multi-Symptom Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)3c7ef3cf-f7f9-42bc-bf20-e36954b9671f2024-03-05WarningsExact identifier
unii: 9D2RTI9KYH
QUALITY CHOICE NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.da06e994-6848-4c1e-9432-31de5e626ea42024-03-02WarningsExact identifier
unii: 9D2RTI9KYH
QUALITY CHOICE DayTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.417c4fa9-6458-40d0-b22a-2415194e250f2024-03-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAurohealth LLC8eaa0eec-cc52-4f1f-8ddb-06c54d577ce22024-03-01WarningsExact identifier
unii: 9D2RTI9KYH
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCebbb2f4b-ba84-40ad-96f6-60225119a33b2024-02-27WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN1c93c45d-1141-4599-83ba-6d3b38f9ffc42024-02-23WarningsExact identifier
unii: 495W7451VQ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen3dc293c9-736b-4bd8-b993-ff83b9909bcd2024-02-23WarningsExact identifier
unii: 495W7451VQ
Lung Large Intestine Meridian OpenerALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHURDeseret Biologicals, Inca5c17770-e1c0-48e7-8947-c0434c22cdab2024-02-21WarningsExact identifier
unii: LMI26O6933
Good Sense Mucus ERGUAIFENESINL. Perrigo Company49de9c3b-9840-4fc2-988f-4361de6aa3c12024-02-21WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
unii: 495W7451VQ
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionse451cb8d-f856-479f-bee9-4cccab210b1e2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Guaifenesin Extended Release 600 mgGUAIFENESINTIME CAP LABORATORIES, INC.10c42869-7df0-3046-e063-6394a90aa6792024-02-07WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRFSA Store Inc. (Caring Mills)57ade7e9-1c68-456c-8853-5acdef7e8f0e2024-02-05WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
unii: 9D2RTI9KYH
Maximum Strength Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRWALGREEN CO.83483b91-77e5-42ca-a467-21312ef32d302024-02-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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