FDA.reportPublic FDA data

NDC 84552-504 - Gozellix

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
84552-504
Package NDCs from labels
84552-504-25
Manufacturer
Telix Innovations SA | TELIX PHARMACEUTICALS (US) INC.
Effective date
2025-04-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gozellix - Telix Innovations SA | TELIX PHARMACEUTICALS (US) INC.Telix Innovations SA | TELIX PHARMACEUTICALS (US) INC.2025-04-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84552-504GOZELLIX (GOZETOTIDE) KIT [TELIX INNOVATIONS SA]2Unmatched20250423_abeab169-e38e-433a-b8a9-f1dab31518c8.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 7 of 21 · 410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STYE EYE RELIEF SERUMVITAMIN EGuangzhou Mizi Biotechnology Co., LTD.3f60193e-4b95-6759-e063-6394a90a991c2025-12-17WarningsExact identifier
unii: PQ6CK8PD0R
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
JBA Verestor Mega Fiber PowderVITAMIN C,VITAMIN E,INULIN,BANANA STEM EXTRACT,NATTOKINASE,HOUTTUYNIA CORDATA EXTRACT,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse7b861da-3851-4a75-b707-4a427c938ee12025-11-28WarningsExact identifier
unii: PQ6CK8PD0R
GLUTATHIONEKOJIC ACIDSKIN LIGHTENINGHANCHOYEANBIOTEC Co.,Ltd.2be274be-e6d0-d961-e063-6294a90a21902025-11-27WarningsExact identifier
unii: PQ6CK8PD0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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