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 67 of 131 · 2,617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
unii: 9D2RTI9KYH
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCdb81e32b-0cad-400b-8479-a3b51de92b122025-10-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWal-mart Stores, Inc.f3933531-aa4d-cb67-1895-f2f14175f1d22025-10-10WarningsExact identifier
unii: 6V9V2RYJ8N
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852b77ae-a5ac-3ead-e053-2a91aa0a54bd2025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp8503c956-42a5-7684-e053-2991aa0adb272025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852ceea2-d6a1-6de2-e053-2a91aa0ad50d2025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852d5f01-9289-5515-e053-2a91aa0acf322025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Diabetic Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp85183b38-ce2a-0e0e-e053-2991aa0a336f2025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp8518fd91-981e-de78-e053-2a91aa0afcb22025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp85065cf3-386d-22d5-e053-2a91aa0a72da2025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8b2c847-25e9-8714-e053-2995a90a73ce2025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Childrens Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c5027f-9701-fb07-e053-2a95a90a60292025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8c052d8-fb9f-09f2-e053-2a95a90a37af2025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c08532-1169-6603-e053-2a95a90a34842025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corp1a4fe686-3085-4543-bd6c-f20580b1df502025-10-09WarningsExact identifier
unii: 9D2RTI9KYH
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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