FDA.reportPublic FDA data

NDC 80587-183 - 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
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 129 of 131 · 2,617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
unii: 9D2RTI9KYH
JEGAMSAN ExtractLONICERA FLOWER, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROMIDEI World Pharmaceutical Co., Ltd.af695c7e-1ad2-ad98-e053-2995a90a2edf2020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
SoCheongRyong Tang ExtractGINGER, CHLORHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af68634f-eb0a-64e7-e053-2a95a90a5df22020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC918b2a90-532b-4358-bdff-9ad48c167a7e2020-08-11WarningsExact identifier
unii: 6V9V2RYJ8N
equate cough dmDEXTROMETHORPHAN POLISTIREXWal-Mart Stores Inc5f72c4ad-1c30-41ea-b39c-7f4bb3deced62020-07-08WarningsExact identifier
unii: 9D2RTI9KYH
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services53acd8d9-b9d8-4a38-8597-32043548d8322020-07-01WarningsExact identifier
unii: 6V9V2RYJ8N
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacy956f0bd4-3266-4754-9bd2-ac480e3bcbce2020-05-27WarningsExact identifier
unii: 9D2RTI9KYH
Allergy and CongestionFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIRite Aid Corporation90e1aa06-b769-e8ac-af88-1d6a256b94872020-05-19WarningsExact identifier
unii: 6V9V2RYJ8N
SorbitolSORBITOLBaxter Healthcare Corporationaea0b5a1-444b-4330-a3ce-26485dbbfe752019-12-31Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CareOne Cough DMDEXTROMETHORPHAN POLISTIREXAmerican Sales Company42f67a3c-8cd7-44a6-8e54-08fb8449e8d72019-12-09WarningsExact identifier
unii: 9D2RTI9KYH
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr. Reddy's Laboratories Inc.6fd05737-d996-b5b6-dccf-bc179a9d606c2019-09-09WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEHEBd9b46ff2-8bde-47c0-bc63-b19dbe7e197b2019-05-29WarningsExact identifier
unii: 6V9V2RYJ8N
12 Hour Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy85955336-3f79-457d-822c-f8be019729d12019-05-23WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy3a3d11e5-ebbf-4356-8ae6-4e5656b5644c2019-04-10WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Consortium, LLCaec6412a-b62c-44c8-84f5-77f5fa4410282019-04-10WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESAM'S WEST INC5a885a10-7751-44f1-b2d9-a918f27604df2019-03-29WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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