NDC 0338-7112 - 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
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 61 of 65 · 1,282 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Distress-Mood-Sadness	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	98d08917-2f1b-4dc7-e053-2a95a90a1ce0	2020-12-02	Warnings	Exact identifier unii: 451W47IQ8X
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9aefc830-329c-5e35-e053-2a95a90a6ffe	2020-11-30	Warnings	Exact identifier unii: 451W47IQ8X
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9af2d6f4-baa8-5da9-e053-2995a90a3dac	2020-11-30	Warnings	Exact identifier unii: 451W47IQ8X
Fatigue Fighter	ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.	Newton Laboratories, Inc.	9aa3c692-fbe0-debe-e053-2995a90add50	2020-11-25	Warnings	Exact identifier unii: 451W47IQ8X
Fatigue Fighter	ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.	Newton Laboratories, Inc.	9ab1c9ba-a90e-7f55-e053-2a95a90a9451	2020-11-25	Warnings	Exact identifier unii: 451W47IQ8X
Feminine Comfort	AGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELIS	Newton Laboratories, Inc.	9ab4520d-1dd3-7b9f-e053-2a95a90a274f	2020-11-25	Warnings	Exact identifier unii: 451W47IQ8X
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	79890e75-dfac-0262-e053-2a91aa0a5ce5	2020-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	798ab5a2-7464-8e9d-e053-2a91aa0acc98	2020-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Cold Hands - Feet	HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA	Newton Laboratories, Inc.	7a2b4f28-2128-a8b2-e053-2a91aa0a2402	2020-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	Asclemed USA, Inc.	afac6cc5-1ced-4639-b6f6-86f40ef5c30e	2020-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
GUNA ALLERGY	ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -	Guna spa	ae6bd80d-2c70-1a3f-e053-2a95a90a2652	2020-10-23	Warnings	Exact identifier unii: 451W47IQ8X
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	a00c4a93-cde2-4753-81f7-0d6fee9fb690	2020-10-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: B22547B95K
Travasol	LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE	Baxter Healthcare Corporation	8543b5be-0f43-4891-9e56-d7c39fe839b5	2020-10-07	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E
Supreme	ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA	BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE	72c4679b-aa97-4888-9178-581d0f99c0b6	2020-09-11	Warnings	Exact identifier unii: 25X51I8RD4
AP II NeckCream	ADENOSINE, NIACINAMIDE	NOKSIBCHO cosmetic Co., Ltd.	aeb29f2c-d1e8-981d-e053-2a95a90a2047	2020-09-07	Warnings	Exact identifier unii: 25X51I8RD4
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ac0fd44a-3f39-8d7e-e053-2995a90afeec	2020-08-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Cardioplegic	CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Corporation	1fd50ce5-2799-4c26-81da-02cf0578dd9e	2020-06-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	ee831456-5962-4d5e-ad0c-69ab85860453	2020-06-03		Exact identifier unii: B22547B95K
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a62b71db-8ba2-6f6b-e053-2a95a90a29d1	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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