FDA.reportPublic FDA data

NDC 0338-8402-01 - 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
0338-8402
Requested NDC
0338-8402-01
Package NDCs from labels
0338-8402-01, 0338-8402-02, 0338-8402-03, 0338-8402-04, 0338-8402-09, 0338-8402-10
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
0338-8402-01TISSEELFibrin Sealant2 mL in 1 SYRINGE, PLASTICSOLUTION29
0338-8402-02TISSEELFibrin Sealant1 in 1 CARTONSOLUTION19
0338-8402-03TISSEELFibrin Sealant4 mL in 1 SYRINGE, PLASTICSOLUTION49
0338-8402-04TISSEELFibrin Sealant1 in 1 CARTONSOLUTION19
0338-8402-09TISSEELFibrin Sealant10 mL in 1 SYRINGE, PLASTICSOLUTION109
0338-8402-10TISSEELFibrin Sealant1 in 1 CARTONSOLUTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-8402TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]8Legacy NDC, 6 package rows20240802_b3f69e25-1b87-4507-81fa-582ea084673d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-8402-01ML - Milliliter0338-8402cbf2520f-e91d-44fa-a468-64bd4e21cbe312022-06-06
0338-8402-02ML - Milliliter0338-840295155609-93b5-4cc5-9907-8c99429aef2812018-01-12
0338-8402-03ML - Milliliter0338-840253cca17c-cdbe-42fb-a3c0-cd18878c3fbe12022-06-06
0338-8402-04ML - Milliliter0338-840218b1ebf7-b9ce-41a9-8593-0bdaefd9efd912018-01-12
0338-8402-09ML - Milliliter0338-8402b6027cf3-c779-4169-8fce-e438b0ba32e612022-06-06
0338-8402-10ML - Milliliter0338-8402ab4c2acb-d2d6-406f-bd13-b1e43ce263ca12018-01-12

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 13 of 62 · 1,227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
CitraNatal 90 DHAVITAMIN C, CALCIUM, IRON, VITAMIN D3, VITAMIN E, THIAMIN, RIBOFLAVIN, NIACINAMIDE, VITAMIN B6, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUMMission Pharmacal Company81e639d7-352e-4eaa-87d9-582da68b97282026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 451W47IQ8X
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 451W47IQ8X
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cellular Oxygenator Drops 2095CELLULAR OXYGENATOR DROPSProfessional Complementary Health Formulas5aba4627-6078-4c9e-93ee-690cfe3439cf2026-01-08WarningsExact identifier
unii: 25X51I8RD4
L-Histidine High 7410L-HISTIDINE HIGHProfessional Complementary Health Formulas7eec7d23-236f-4770-9587-1bf602fd91c22026-01-08WarningsExact identifier
unii: 4QD397987E
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 451W47IQ8X
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: M4I0D6VV5M
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Proteinuria Drops 2053PROTEINURIA DROPSProfessional Complementary Health Formulas1bf80282-8283-4835-acd4-fbdb47788c672026-01-08WarningsExact identifier
unii: ZIF514RVZR
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Shingles Nosode 4028SHINGLES NOSODEProfessional Complementary Health Formulase71d917a-af9f-41e9-a3de-cb588db7e0222026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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