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 76 of 118 · 2,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBETTER LIVING BRANDS LLC.f29c604a-271d-a702-e053-2a95a90a34272025-02-12WarningsExact identifier
unii: 9D2RTI9KYH
Nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c01090-645c-1efe-e053-2995a90a7df52025-02-12WarningsExact identifier
unii: 9D2RTI9KYH
AXIV DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC131b1f17-cd86-f9b3-e063-6294a90a30282025-02-12WarningsExact identifier
unii: 9D2RTI9KYH
Mucus ReliefGUAIFENESINP & L Development, LLCa2d14780-4a69-496e-86fe-7f2443cb0f202025-02-12WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates, LLC17d0dbc7-c8c2-7917-e063-6394a90a42af2025-02-12WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DAYTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEKroger Companybc00bbf8-52bb-fa75-e053-2a95a90a94062025-02-11WarningsExact identifier
unii: 9D2RTI9KYH
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacya9765a9b-3ae3-45bc-ab59-06ec5249e2c92025-02-11WarningsExact identifier
unii: 9D2RTI9KYH
Daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELSTIME CAP LABORATORIES, INC.fd24653e-c4fa-3c09-e053-6394a90aaa9e2025-02-10WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC74fa022a-bad9-4d0f-8dda-5624fae3867b2025-02-10WarningsExact identifier
rxcui: 1298324
unii: 9D2RTI9KYH
unii: 495W7451VQ
NIGHTTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEKroger Companybc0115a3-5322-855d-e053-2995a90aba272025-02-10WarningsExact identifier
unii: 9D2RTI9KYH
Day time high blood pressure cold and fluACETAMINOPHEN DEXTROMETHORPHAN HBRCamber Consumer Care09fbd872-0970-4864-9308-4a7b859839202025-02-10WarningsExact identifier
unii: 9D2RTI9KYH
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
unii: 9D2RTI9KYH
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: LMI26O6933
SanaTos Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Dextromethorphan hydrobromide and quinidine sulfateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATECamber Pharmaceuticals, Inc.7028dcb7-f436-4cf6-9beb-23c1d215c7982025-02-03Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONNuCare Pharmaceuticals,Inc.0b7bfbab-decb-970c-e063-6394a90a50ef2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
NIGHTIME COLD AND FLUNIGHTIME COLD AND FLUTARGET CORP9dee9b92-eac9-b07d-e053-2995a90a06022025-01-31WarningsExact identifier
unii: 9D2RTI9KYH
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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