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 68 of 131 · 2,617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TexaClear Severe Cough, Cold and FluCHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGM Pharmaceuticals, INCcb99e5b3-1908-43c9-b31f-d35e7ce58b442025-10-06WarningsExact identifier
unii: 9D2RTI9KYH
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsExact identifier
unii: 9D2RTI9KYH
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsExact identifier
unii: 9D2RTI9KYH
RoboHBr Cough SUPPRESSANTDEXTROMETHORPHAN HBRDXM Pharmaceutical, Inc0af624ce-191f-45e1-882b-e8acb90cc77b2025-10-06WarningsExact identifier
unii: 9D2RTI9KYH
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus DGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company86993cd9-5d55-4a70-8a33-701d914822922025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
sinus 12 hourPSEUDOEPHEDRINE HCLL. Perrigo Company26206f75-648f-47c9-8bad-25127c33961d2025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
mucus DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companydb6ada8a-1799-4d35-8bda-4a322fbd7a062025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
unii: 9D2RTI9KYH
All Day Allergy DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companyb38cb1c8-3575-4283-8692-00cd4cd8d5cc2025-10-02WarningsExact identifier
unii: 6V9V2RYJ8N
Equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEUnited Natural Foods, Inc. dba UNFI3053f6d7-0eff-488c-8901-770dcc62af062025-10-02WarningsExact identifier
unii: 9D2RTI9KYH
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEBIONPHARMA INC.3ff18027-44fb-50a1-e063-6394a90a23902025-10-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: 6V9V2RYJ8N
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
unii: 9D2RTI9KYH
NyQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company724d0889-5ba5-3125-e053-2a91aa0a92c12025-10-01WarningsExact identifier
unii: 9D2RTI9KYH
DayQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company724f2833-34bd-6a9e-e053-2991aa0a073d2025-10-01WarningsExact identifier
unii: 9D2RTI9KYH
MUCINEX DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsfcaf1df9-b396-44f2-94ce-e46e80aba66c2025-10-01WarningsExact identifier
unii: 9D2RTI9KYH
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
unii: 9D2RTI9KYH
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
unii: PDC6A3C0OX
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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