FDA.reportPublic FDA data

NDC 59368-274 - Cough 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
59368-274
Package NDCs from labels
59368-274-01
Manufacturer
Sixarp, LLC
Effective date
2025-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cough DM - Sixarp, LLCSixarp, LLC2025-09-15HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-274COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PRAXIS, LLC]1Unmatched20250305_2f72c3b5-541c-dd77-e063-6394a90a6375.zip

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 108 of 117 · 2,329 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAhold U.S.A., Inc,738bbea4-4243-4cbd-980e-a22451b85c4c2023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Expectorant and Cough Suppressant Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HBRWinco Foods, LLC.ac1c8633-4064-4e2f-9b43-4ae9bdd1a4272023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAhold U.S.A., Inc,e9add770-58e0-4cf3-bbc2-d293ca870b032023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLCa1921611-343c-4c2a-846d-c8de19dddab52023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Expectorant and Cough SuppressantGUAIFENESIN AND DEXTROMETHORPHAN HBRWinco Foods, LLC.e7e16bab-a7aa-4911-9a29-0c986b26da672023-12-01WarningsExact identifier
unii: 9D2RTI9KYH
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
unii: PDC6A3C0OX
Akin Cough Formula DM Strawberry BananaDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSouthern Sales & Service, Inc.7a81efd8-775d-455e-860f-f3e3b369a0a72023-11-29WarningsExact identifier
unii: 9D2RTI9KYH
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
unii: 9D2RTI9KYH
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEEpic Pharma, LLC61cc890b-eb3d-494c-ae45-629a27e721ce2023-11-29Warnings, Adverse reactionsExact identifier
unii: 1699G8679Z
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
unii: 9D2RTI9KYH
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
unii: 9D2RTI9KYH
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
unii: 9D2RTI9KYH
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRA-S Medication Solutions786607e9-ee2d-4510-8556-857032e4053f2023-11-22WarningsExact identifier
unii: 9D2RTI9KYH
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
unii: 9D2RTI9KYH
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
unii: 9D2RTI9KYH
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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