FDA.reportPublic FDA data

NDC 0338-7332-01 - TISSEEL Fibrin Sealant

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
0338-7332
Requested NDC
0338-7332-01
Package NDCs from labels
0338-7332-01, 0338-7332-02, 0338-7332-05
Manufacturer
Baxter Healthcare Corporation
Effective date
2025-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TISSEEL Fibrin Sealant - Baxter Healthcare CorporationBaxter Healthcare Corporation2025-09-30PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-7332-01TISSEELFibrin Sealant1 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION1 mL500 [iU] in 1mL9
0338-7332-01TISSEELFibrin Sealant1 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION1 mL500 [iU] in 1mL9
0338-7332-02TISSEELFibrin Sealant2 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION2 mL500 [iU] in 1mL9
0338-7332-02TISSEELFibrin Sealant2 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION2 mL500 [iU] in 1mL9
0338-7332-05TISSEELFibrin Sealant5 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION5 mL500 [iU] in 1mL9
0338-7332-05TISSEELFibrin Sealant5 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION5 mL500 [iU] in 1mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-7332TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]8Unmatched20240802_b3f69e25-1b87-4507-81fa-582ea084673d.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 44 of 61 · 1,210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
Cellular OxygenatorCACTUS GRANDIFLORUS, ASCORBICUM ACIDUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, THIAMINUM HYDROCHLORICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, RIBOFLAVINUM, MAGNESIA PHOSPHORICA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, ANTHRACHINONUM, COENZYME A, NADIDUM, NAJA TRIPUDIANS, UBIDECARENONUM (COQ10)Nutritional Specialties, Inc.e5869f25-276f-456a-ab05-2a1899845afb2023-11-21WarningsExact identifier
unii: 25X51I8RD4
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR SUIS, KIDNEY (SUIS), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.5d323e16-e9a5-4933-9593-285c7b3c54ce2023-11-17WarningsExact identifier
unii: M4I0D6VV5M
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
B Complex LiquescenceCHOLINUM (CHOLINE), INOSITOL (VITAMIN B8), FOLIC ACID (VITAMIN B9), PANTOTHENIC ACID (CALCIUM PANTOTHENATE, VITAMIN B5), THIAMINUM HYDROCHLORICUM (VITAMIN B1), HEART (BOVINE), HEPAR (BOVINE), METHYLCOBALAMIN (VITAMIN B12), NICOTINAMIDUM (VITAMIN B3), PABA (PARA AMINOBENZOIC ACID VITAMIN B10), PYRIDOXINUM HYDROCHLORICUM (VITAMIN B6), BIOTIN (VITAMIN B7), HORDEUM VULGARE, RIBOFLAVINUM (VITAMIN B2), TORULA CEREVISIAENutritional Specialties, Inc.a7382d84-1d5f-4d09-962f-b26f265af65e2023-10-09WarningsExact identifier
unii: 25X51I8RD4
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
unii: 4QD397987E
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: 451W47IQ8X
Reoganic EX Whitening Pore Care DeodorantARBUTIN, NIACINAMIDE, ADENOSINELAON COMMERCE co ltd05ece831-63e8-d347-e063-6294a90a43472023-09-22WarningsExact identifier
unii: 25X51I8RD4
Reoganic Body Firming StretchCreamNIACINAMIDE, ADENOSINELAON COMMERCE co ltd05ee1e29-0daa-9cbd-e063-6394a90a07492023-09-22WarningsExact identifier
unii: 25X51I8RD4

Reported adverse events (FAERS/openFDA)#

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