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 41 of 118 · 2,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b225e897-5728-4519-b727-c0f361c759762026-01-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
tussin cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation13618054-d0c5-4190-b626-e7e91b8557382026-01-06WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALOE, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUMEnergique, Inc.3ddbed50-7ca9-493c-ba94-321c2afef60e2026-01-06WarningsExact identifier
unii: LMI26O6933
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
unii: 9D2RTI9KYH
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
unii: 495W7451VQ
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
unii: 9D2RTI9KYH
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
unii: 9D2RTI9KYH
Brompheniramine, Pseudoephedrine, DextromethorphanBROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHANAscend Laboratories, LLC036b587a-7bfe-4149-bd05-34a37e3e84b62026-01-02Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
unii: 495W7451VQ
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
unii: 495W7451VQ
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc6bdfa599-7898-4c05-927c-52fb82e0e6862026-01-02WarningsExact identifier
unii: 9D2RTI9KYH
PANCOLD AACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUSDONGWHA PHARM. CO. LTD.fc8f1807-d344-ccc2-e053-6294a90a50892025-12-31WarningsExact identifier
unii: 495W7451VQ
ED A-HIST DMDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.e0e2b117-62bc-4132-9f7c-fe2a912052b12025-12-31WarningsExact identifier
unii: 9D2RTI9KYH
Bio-Z-CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAdvanced Generic Corporation05e70eab-1467-4b09-991e-ef03f222e0212025-12-31WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Altipres-BBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAlternative Pharmacal Corporationfd00c41d-0580-4177-afaa-60bb12ca5a092025-12-31WarningsExact identifier
unii: 9D2RTI9KYH
Llorens Care Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.4743e562-1217-50ab-e063-6394a90af88d2025-12-31WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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