NDC 0338-7112-01 - 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: 0338-7112
Requested NDC: 0338-7112-01
Package NDCs from labels: 0338-7112-01, 0338-7112-02, 0338-7112-05
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
Label	Manufacturer	Effective date	Type
TISSEEL Fibrin Sealant - Baxter Healthcare Corporation	Baxter Healthcare Corporation	2025-09-30	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-7112-01	TISSEELFibrin Sealant	1 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1 mL	86.5 mg in 1mL	9
0338-7112-01	TISSEELFibrin Sealant	1 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1 mL	86.5 mg in 1mL	9
0338-7112-02	TISSEELFibrin Sealant	2 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	2 mL	86.5 mg in 1mL	9
0338-7112-02	TISSEELFibrin Sealant	2 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	2 mL	86.5 mg in 1mL	9
0338-7112-05	TISSEELFibrin Sealant	5 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	5 mL	86.5 mg in 1mL	9
0338-7112-05	TISSEELFibrin Sealant	5 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	5 mL	86.5 mg in 1mL	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-7112	TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]	8	Unmatched	20240802_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 40 of 62 · 1,227 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergies	APIS 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, CINNAMOMUM	Newton Laboratories, Inc.	9d5dea47-5103-21a3-e053-2995a90aee78	2024-05-20	Warnings	Exact identifier unii: 451W47IQ8X
Colopar	COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS	Energique, Inc.	c47d7203-abcd-4ae5-bf9b-5df07e07d3c1	2024-05-20	Warnings	Exact identifier unii: 451W47IQ8X
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	4510fe59-cc28-4585-925f-42508a60abd0	2024-05-13	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	47a0313f-36df-4fa6-a828-c9e1946ba9b0	2024-05-08	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	f0cc6713-4d47-49be-8116-901c99002b6b	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	7f22c06b-6b4d-4b49-a4b2-d2169f2bd653	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	Asclemed USA, Inc.	f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	97001218-086c-430a-9e0d-6c7031c91d94	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Prenatol-M	MULTIVITAMIN	PureTek Corporation	17559a44-94b7-9ca0-e063-6294a90a2123	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 25X51I8RD4
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	fe5b5182-c859-4c74-b2e0-467be5b2e329	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	f2475fa3-ab1d-4b81-8127-b58cd0790a54	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Weed Grass Antigens	ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,	Energique, Inc.	8a28f56a-6010-42e3-b360-e6e22b86222a	2024-05-02	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	c2467d57-cd2d-4409-bcc0-50128bd01bba	2024-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Mineffect eye drops	ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM	Kadesh Incoporation Co,Ltd	e2259f58-3043-4af3-918d-d4403757aa1f	2024-04-26	Warnings	Exact identifier unii: 451W47IQ8X
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	2024-04-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
VACC HC	HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM	Deseret Biologicals, Inc.	a98082ba-21ec-4cf8-b81c-bcb41eb9fd12	2024-04-23	Warnings	Exact identifier unii: 25X51I8RD4
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c1e52670-c85e-4f19-a2e9-bf9abd7c3727	2024-04-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
PEMF Optimizer	AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	97d57469-4c5b-4d3f-9398-3a1a6617a649	2024-04-23	Warnings	Exact identifier unii: 059QF0KO0R
Dermapar	EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM	Energique, Inc.	f79fe29b-341e-4bee-9665-1805a7157d1a	2024-04-22	Warnings	Exact identifier unii: 451W47IQ8X
Multitol-M	MULTIVITAMIN, FOLATE	PureTek Corporation	163fdc9e-a405-c3ee-e063-6294a90afd49	2024-04-17	Warnings, Adverse reactions	Exact identifier unii: 25X51I8RD4

Reported adverse events (FAERS/openFDA)#

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