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 131 of 131 · 2,617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIHEB0de7fc37-7f46-4e98-d5ac-d31a3c313a622017-12-07WarningsExact identifier
unii: 6V9V2RYJ8N
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 506T60A25R
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRRichmond Pharmaceuticals, Inc59b00858-e5c9-420a-bc7e-46953722cde62017-10-30WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAdvance Pharmaceutical Inc.e507a84a-59d5-47f2-a2df-f342e4b093b42017-10-30WarningsExact identifier
unii: 9D2RTI9KYH
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NightTime Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINEVelocity Pharma516fc924-61f0-40ee-9688-3c6da817b4622017-09-11WarningsExact identifier
unii: 9D2RTI9KYH
Walgreens Adult Nighttime Wal Tussin DM Max Maximum StrengthDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREEN CO.385a1e0b-09c5-4f2d-8404-086020e5c8912017-09-07WarningsExact identifier
unii: 9D2RTI9KYH
maximum strength mucus relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
unii: 9D2RTI9KYH
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
BRONCOCHEM KIDS ALLERGY CONTROLCHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBRLABORATORIO MAGANCEHM INTERNATIONAL SRL36574266-a6ca-443d-9e1d-85240aabe8a22017-04-10WarningsExact identifier
unii: 9D2RTI9KYH
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCICVS Pharmacy3e295047-1a46-a0d8-2e3f-ec4086f5aedb2015-08-24WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIWalgreens Company37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32015-08-04WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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