FDA.reportPublic FDA data

NDC 59368-266 - Leader 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
59368-266
Package NDCs from labels
59368-266-01
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
Leader Cough DM - Sixarp, LLCSixarp, LLC2025-09-15HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-266LEADER COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PRAXIS, LLC]1Unmatched20250302_2f231bb9-fe93-a478-e063-6294a90a2809.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 72 of 117 · 2,329 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATEBryant Ranch Prepack9a50c6d4-e619-438d-8af9-bb758ea7ba7e2025-05-12Warnings, Adverse reactionsExact identifier
unii: 1699G8679Z
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
unii: 9D2RTI9KYH
SUKKHI Polyamino Sugar Condensate Massage CreamSUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd34aaf4ef-26dc-f87e-e063-6394a90a9a592025-05-08WarningsExact identifier
unii: PDC6A3C0OX
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
unii: 9D2RTI9KYH
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAsclemed USA, Inc.702eb7c0-db4c-4729-b69e-99f64c63c7bd2025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc3febf0e0-b587-495a-9608-3a2dfbc327912025-05-07WarningsExact identifier
unii: 9D2RTI9KYH
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
unii: 9D2RTI9KYH
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
unii: 9D2RTI9KYH
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEBurel Pharmaceuticals, LLC8bbeae67-a7ff-4fa6-b21e-fb8617cd91972025-05-01Warnings, Adverse reactionsExact identifier
unii: 1699G8679Z
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter17eee39b-5a7a-ba20-e063-6294a90ac3922025-04-29WarningsExact identifier
unii: 9D2RTI9KYH
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter826d9c3c-7535-48bb-906e-d75e2ec670db2025-04-29WarningsExact identifier
unii: 9D2RTI9KYH
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
unii: 9D2RTI9KYH
good neighbor pharmacy childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEAmerisource Bergencde0fd43-771f-4528-bad2-5727efec52502025-04-17WarningsExact identifier
unii: 9D2RTI9KYH
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEXttrium Laboratories, Inc30c9d769-bc74-04d2-e063-6294a90a665a2025-04-07Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLC02d2a5a6-36bb-45b5-aba7-779615b276ed2025-04-05WarningsExact identifier
unii: 9D2RTI9KYH
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
unii: 9D2RTI9KYH
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
unii: 9D2RTI9KYH
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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