FDA.reportPublic FDA data

NDC 84552-503 - 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
84552-503
Package NDCs from labels
84552-503-64
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
84552-503GOZELLIX (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 8 of 21 · 410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Super vitamin C serumSUPER VITAMIN CFlexiGo Inc41cbe84e-3ddf-b806-e063-6294a90a55a42025-10-22WarningsExact identifier
unii: PQ6CK8PD0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium acetate anhydrousSODIUM ACETATE ANHYDROUSSomerset Therapeutics, LLC93edebd6-ef7f-483a-80b6-bfaf34ea5ded2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERMETHOD PHARMACEUTICALS, LLC1f8785db-3e65-49d7-b017-b1a65b5ec6b12025-10-21WarningsExact identifier
unii: PQ6CK8PD0R
Multi-Vitamin Drops with Fluoride and IronVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FERROUS SULFATE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCd5609742-e456-4409-bca9-706b0ea90d352025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC42ed15a5-aad6-4ab3-b95b-f9534a419f402025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC71698332-4ab1-4cbb-a98d-1694b715924b2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLCa5af0d8e-5d83-40bb-8df5-3af7277d72cf2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLC880df628-5bba-4dc4-b557-1fcc822adba82025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCfe1e8e8a-0902-4598-bb06-fe5163c1cffb2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC003181d4-5412-4ffe-b99d-880f2010e3ad2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC5acff360-8d44-44d7-864d-52f213501d032025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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