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 126 of 129 · 2,573 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEProficient Rx LP1b79a7d8-a8f4-4525-8b94-3e317fc5a7172022-04-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
unii: 6V9V2RYJ8N
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONProficient Rx LP68a4c521-6db0-4e94-9906-96e96e2513012022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCd139fd8d-66fd-4484-8e78-ed90c505d9992022-02-08WarningsExact identifier
unii: 6V9V2RYJ8N
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAurohealth LLC6adf9292-b4af-4cb4-99f3-dda03734570a2022-01-21WarningsExact identifier
unii: 6V9V2RYJ8N
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOCOLD-FACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDELydia Co., Ltd.d0b20c56-de2a-1489-e053-2995a90a6a062021-11-13WarningsExact identifier
unii: 9D2RTI9KYH
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC8127c389-c1e3-4f2e-b306-13587b5b50c42021-08-09WarningsExact identifier
unii: 9D2RTI9KYH
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCdcfb71a1-2a5b-4847-a23d-bbe381badcf62021-07-20WarningsExact identifier
unii: 9D2RTI9KYH
Signature Care Cough ReliefDEXTROMETHORPHAN POLISTIREXSafewayf95d0519-e96b-45fe-974c-8fe6b9b8c88c2021-07-13WarningsExact identifier
unii: 9D2RTI9KYH
basic care mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCac01ad52-483a-4cce-9279-51ceecada9b92021-07-13WarningsExact identifier
unii: 9D2RTI9KYH
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC5b7c2306-ad87-48b0-99b7-71427907db0c2021-03-23WarningsExact identifier
unii: 9D2RTI9KYH
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCa0f35883-9dd3-49e7-87ac-ce04561ad6c32021-03-09WarningsExact identifier
unii: 9D2RTI9KYH
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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