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 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| CVS Health Sterile Saline Mist Live Better | SODIUM CHLORIDE | CVS Pharmacy | ccc3ab8c-b22f-420d-869b-f2a65b8c7180 | 2021-03-13 | Warnings | 451W47IQ8X |
| VITA SNAIL | NIACINAMIDE, ADENOSINE | NOKSIBCHO cosmetic Co., Ltd. | 89aff52c-552a-4e87-8a2c-bb6734441a8f | 2021-03-03 | Warnings | 25X51I8RD4 |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | aeaed9cb-b629-4019-88d2-a916179427de | 2021-02-19 | Warnings, Adverse reactions | 451W47IQ8X |
| GUNA KIDNEY PLUS | CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP - | Guna spa | b8dacd94-8da1-4a8d-e053-2995a90acb67 | 2021-02-04 | Warnings | 451W47IQ8X |
| Natrum Muriaticum | NATRUM MURIATICUM | True Botanica, LLC | b30b2880-28a1-47bd-83e7-da885a7c6f77 | 2021-01-24 | Warnings | 451W47IQ8X |
| Met-Tox | ARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODES | wHITE mANUFACTURING INC DBA MICRO-WEST | e65db4c2-0bc7-4c50-8f18-b36ee004c4f5 | 2021-01-21 | Warnings | 451W47IQ8X |
| HPZ | ECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCC | White Manufacturing Inc. DBA Micro-West | dfbb5a35-8dfe-48f4-9177-6cb52fb44090 | 2021-01-21 | Warnings | 451W47IQ8X |
| TOTAL TRI-ESTRO | ADRENALINUM, CIMICIFUGA, IGNATIA, LECITHIN, NICOTINAMIDUM, OOPHORINUM, SEPIA. | White Manufacturing Inc. DBA Micro-West | d3a5e7b6-a4d2-406e-b837-600a886b0ff4 | 2021-01-21 | Warnings | 25X51I8RD4 |
| Metal | ALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIA | NET Remedies | f7682a4e-c767-4429-98aa-e8c5ef6560a6 | 2021-01-19 | Warnings | 451W47IQ8X |
| 3% Sodium Chloride | 3% SODIUM CHLORIDE | Becton Dickinson and Company | a8058593-48af-457a-b0f0-166935c7d10c | 2021-01-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Asclemed USA, Inc. | a411c118-ef0e-4c42-9924-4a06ec690e94 | 2021-01-14 | Adverse reactions | 451W47IQ8X |
| OHM-DREN LFT | APIS MELLIFICA, ARANEA DIADEMA, BERBERIS VULGARIS, EQUISETUM HYEMALE, GALIUM APARINE, JUGLANS REGIA, MANGANUM PHOSPHORICUM, NICOTINAMIDUM, NITRICUM ACIDUM, SARSAPARILLA, THUJA OCCIDENTALIS, URTICA URENS | OHM PHARMA INC. | 31f4eaab-fbd6-4924-b956-c0ff2934fbf0 | 2021-01-11 | Warnings | 25X51I8RD4 |
| Intestia | ECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUM | Newton Laboratories, Inc. | 9a132c99-7278-f667-e053-2a95a90a3d2b | 2020-12-04 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.