FDA.reportPublic FDA data

NDC 80587-183-01 - DURATUSS 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
80587-183
Requested NDC
80587-183-01
Package NDCs from labels
80587-183-01, 80587-183-02
Manufacturer
Prime Labs LLC dba Quality CDMO
Effective date
2025-11-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DURATUSS DM - Prime Labs LLC dba Quality CDMOPrime Labs LLC dba Quality CDMO2025-11-19HUMAN OTC DRUG LABEL

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 124 of 129 · 2,573 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
ChemDetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUMDr. Donna Restivo DC2a17f80d-12c0-43a0-980b-9da648e9b76a2023-01-10WarningsExact identifier
unii: 506T60A25R
DAYTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCLWalgreensdbf5656b-9105-871b-e053-2995a90a49412023-01-03WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC9870b7ee-2bfb-42f5-9762-77d2dd13434a2022-12-06WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan Hydrobromide HBRGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDERITE-AID2343f031-d658-498a-b5d1-6dcdb26b3cf02022-12-06WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSUN PHARMACEUTICAL INDUSTRIES, INC.06328741-03e3-49cf-ae44-d4c2116e38a32022-12-06WarningsExact identifier
unii: 9D2RTI9KYH
MAXIMUM STRENGTH Mucus DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy9a560b80-972c-4af5-8fe8-eaef0b0d83b32022-12-01WarningsExact identifier
unii: 6V9V2RYJ8N
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
DG health mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLCadd72ca5-94cd-437f-b30f-6149c08b5f212022-11-14WarningsExact identifier
unii: 9D2RTI9KYH
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAmerisource Bergen8d397f4f-ac5e-426d-a26b-ee064b6e50282022-11-04WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HClPSEUDOEPHEDRINE HCLAurohealth LLC1056d9da-8a3f-4b7a-878e-7f8d45d298cd2022-11-03WarningsExact identifier
unii: 6V9V2RYJ8N
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCare One (Retail Business Services, LLC.)eb3ef974-4e79-4065-a8c9-9307092da6b32022-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCare One (Retail Business Services, LLC.)93658f3c-1f57-41b5-acdc-ee7ee47656a32022-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRCardinal Health (Leader) 7000004af43e6-6276-42ec-a902-3de22bc9fdea2022-10-20WarningsExact identifier
unii: 9D2RTI9KYH
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
topcare 12 hour decongestantPSEUDOEPHEDRINE HYDROCHLORIDETopco Associates LLC4841c79a-fb92-4209-929a-e4ea0c4015dd2022-10-05WarningsExact identifier
unii: 6V9V2RYJ8N
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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