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 102 of 117 · 2,329 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold Relief Daytime Honey GingerACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC44404c6a-8031-4f4b-a48e-3739a11a0d2c2024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
ActivcinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.e06a4d72-cc8d-fd9d-e053-2995a90a7a762024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Coldtac Plus SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5ce5c6-a03f-2ad3-e053-6394a90a99f62024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Desresfriol-DX SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5e0e0f-bfd2-b02b-e053-6394a90afe8a2024-04-05WarningsExact identifier
unii: 9D2RTI9KYH
MotivationDIOSCOREA VILLOSA, LECITHIN, SEPIA, VIOLA ODORATA, ADRENALINUM, LITHIUM CARBONICUM, THYROIDINUM (BOVINE), PLACENTA TOTALIS SUIS, GUAIACUM, SOLANUM TUBEROSUM, ANTIMONIUM CRUDUM, AURUM SULPHURATUM, BARYTA CARBONICA, CHININUM SULPHURICUM, CONIUM MACULATUM, GRAPHITES, LILIUM TIGRINUM, RHUS VENENATA, SELENIUM METALLICUM, ALUMINADeseret Biologicals, Inc.c2bb0fb2-7ffa-4d16-8fff-b4c3dde966f42024-04-01WarningsExact identifier
unii: LMI26O6933
DAYTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAdvanced Rx LLC38299cf3-e884-4676-8cc4-6dd64e7d023c2024-03-30WarningsExact identifier
unii: 9D2RTI9KYH
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEAdvanced Rx LLCd1542362-19c5-4470-89e8-87d26e2ca8ed2024-03-30WarningsExact identifier
unii: 9D2RTI9KYH
Mucus DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAmerisource Bergenbf4bcec8-7136-4ae7-a459-a30ee881b98d2024-03-29WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
ANTIGRIP NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLPharmadel LLC12de30fd-95b6-f16d-e063-6294a90aeba22024-03-27WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)0044c53c-11dd-41a9-a5d9-622dd8b1c1442024-03-27WarningsExact identifier
unii: 9D2RTI9KYH
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINBryant Ranch Prepack9812056b-736e-40c5-ae60-21dd9221397c2024-03-22WarningsExact identifier
unii: 495W7451VQ
Tussin CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)1b7b5811-722e-4c4a-844d-c05fa5cfb2e52024-03-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC6bec225e-a203-4866-b0db-b76f73a6ae252024-03-19WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)06d47104-a8ca-48cc-b27e-08c9d018c37b2024-03-19WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b80dae7f-ed2d-4a9e-bef9-f1ed8add01742024-03-19WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRDr. Reddy's Laboratories Inc.49d7f70d-ff79-0708-3eda-efa5bf61da6c2024-03-19WarningsExact identifier
rxcui: 1298324
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Robitussin Cough and Cold CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCfcd0a8e0-ac2a-039a-be3c-534195d6bcfd2024-03-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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