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 | Type |
|---|---|---|---|
| TISSEEL Fibrin Sealant - Baxter Healthcare Corporation | Baxter Healthcare Corporation | 2025-09-30 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| DERLADIE WITCH HAZEL PERFECT VITAMIN GELCREAM | NIACINAMIDE, ADENOSINE | LAON COMMERCE co ltd | c76c4bc7-1f7b-252e-e053-2a95a90aa215 | 2021-07-18 | Warnings | 25X51I8RD4 |
| DERLADIE WITCH HAZEL PERFECT VITAMIN SERUM | NIACINAMIDE, ADENOSINE | LAON COMMERCE co ltd | c7709e83-3246-d4f8-e053-2a95a90a2bbe | 2021-07-18 | Warnings | 25X51I8RD4 |
| 0.9% SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c755e41b-acba-7234-e053-2995a90aff0f | 2021-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| THE SKINHOUSE VITA SNAIL FIRST ESSENSE | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 20fcfd5c-7645-453a-a761-d355b0f1efc6 | 2021-07-15 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE TONER | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 847fd2db-7202-4d81-85b7-03a46cfe3e66 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE SERUM | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 03a97ef0-6ad1-47ef-a8f4-fd32fd02a199 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | a2caa508-e74b-40d7-8cde-20280731c2a6 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 2f121591-4c13-4824-95d6-bd3ab4ee17c9 | 2021-07-14 | Warnings | 25X51I8RD4 |
| COXIR INTENSIVE EGF PEPTIDE MASK PACK | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 68542629-f580-46b9-a4b6-efb055b17fc5 | 2021-07-14 | Warnings | 25X51I8RD4 |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | 451W47IQ8X |
| THE SKINHOUSE ALOE SOOTHING VITAMIN | NIACINAMIDE | NOKSIBCHO cosmetic Co., Ltd. | 516f3790-a127-455c-9eae-d41895fe2411 | 2021-07-14 | Warnings | 25X51I8RD4 |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 4a655cde-283f-4ec8-a3d9-5f539c55c204 | 2021-05-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ed8fd0c1-ac42-4267-877e-ceadf3831c90 | 2021-04-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Dr. Talbots Vital 12 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC | Talbot's Pharmaceuticals Family Products, LLC | c10bb804-8169-63da-e053-2a95a90a8306 | 2021-04-28 | Warnings | 451W47IQ8X |
| Dr. Talbots Infant Daily Allergy Relief | ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC | c0963200-67dd-6349-e053-2a95a90adde1 | 2021-04-22 | Warnings | 451W47IQ8X |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 451W47IQ8X 4QD397987E M4I0D6VV5M |
| CLINIMIX | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE | Baxter Healthcare Corporation | dccff103-8695-400c-a15d-cc2fd078760a | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E |
| Sodium Chloride | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | c3f8e83c-4fb9-91da-e053-2a95a90abd63 | 2021-04-12 | Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.