FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
TISSEEL Fibrin Sealant - Baxter Healthcare CorporationBaxter Healthcare Corporation2025-09-30PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-7112-01TISSEELFibrin Sealant1 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION1 mL86.5 mg in 1mL9
0338-7112-01TISSEELFibrin Sealant1 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION1 mL86.5 mg in 1mL9
0338-7112-02TISSEELFibrin Sealant2 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION2 mL86.5 mg in 1mL9
0338-7112-02TISSEELFibrin Sealant2 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION2 mL86.5 mg in 1mL9
0338-7112-05TISSEELFibrin Sealant5 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION5 mL86.5 mg in 1mL9
0338-7112-05TISSEELFibrin Sealant5 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION5 mL86.5 mg in 1mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-7112TISSEEL 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 62 of 65 · 1,282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACTATED RINGERS AND DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirsta62cf623-9b8a-37e0-e053-2995a90add5b2020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Hay FeverAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENSNewton Laboratories, Inc.a6045b91-d361-2731-e053-2a95a90a97722020-05-18WarningsExact identifier
unii: 451W47IQ8X
Isolyte SSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.7e8fe27f-ff82-48c1-9bf6-3c589c8e985d2020-05-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDEDEXTROSE MONOHYDRATE, SODIUM CHLORIDEFresenius Kabi USA, LLCb825c9c4-f2fb-4a4a-9d8c-fb020ad07e932020-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
XYCOS PINK COLLAGENCREAMADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a378068a-9b5f-f231-e053-2a95a90a413f2020-04-17WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE ROSE HeavenEmulsionADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a2c171f7-243a-fb85-e053-2995a90a4d802020-04-08WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE Vital BrightEmulsionNIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a2c19f6e-80d2-8178-e053-2995a90a1a892020-04-08WarningsExact identifier
unii: 25X51I8RD4
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2b8220f-e33a-51c3-e053-2995a90a07342020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SFERANGS VITA C CAPSULEBOOSTERNIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a22c67a6-1841-2419-e053-2995a90a91922020-03-31WarningsExact identifier
unii: 25X51I8RD4
XYCOS PINK COLLAGENADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a22c9f95-e3ab-bfd3-e053-2995a90a3c662020-03-31WarningsExact identifier
unii: 25X51I8RD4
XYCOS PINK COLLAGEN SERUMADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a22d3cad-f8e7-7339-e053-2a95a90af8a42020-03-31WarningsExact identifier
unii: 25X51I8RD4
XYCOS PINK COLLAGEN TONERADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a22d5d31-4c3f-651c-e053-2a95a90ae5412020-03-31WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE ROSE HEAVENADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21c097c-82ac-3a21-e053-2995a90a63eb2020-03-30WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE Rose HeavenCreamADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21ba34c-2d2d-8033-e053-2995a90a1d742020-03-30WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE ROSE HEAVEN SERUMADENOSINE, NIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21c72f8-00ff-0971-e053-2995a90a2f972020-03-30WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE Vital BrightCreamNIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21cbf42-482c-2d95-e053-2a95a90a1a482020-03-30WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE Vital Bright EmulsionNIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21d0eba-a96c-72e8-e053-2995a90addfb2020-03-30WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE Vital Bright EyeCreamNIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21d3c87-0a7f-2e15-e053-2a95a90aee692020-03-30WarningsExact identifier
unii: 25X51I8RD4
THE SKIN HOUSE Vital BrightSerumNIACINAMIDENOKSIBCHO cosmetic Co., Ltd.a21d8184-258f-679e-e053-2995a90ad7c42020-03-30WarningsExact identifier
unii: 25X51I8RD4

Reported adverse events (FAERS/openFDA)#

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