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 |
|---|---|---|---|---|---|---|
| Ancient Secrets Breathe Again | SODIUM CHLORIDE | LOTUS BRANDS, INC. | c6d2bab0-d363-4c09-a71b-ae15db915b37 | 2024-12-18 | Warnings | 451W47IQ8X |
| Walgreens Saline Mist Extra Strength | SODIUM CHLORIDE | Walgreen's Corporation | 90cbe2dc-36b6-77fb-e053-2995a90a2897 | 2024-12-18 | Warnings | 451W47IQ8X |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 6f1fe980-ca09-401d-aed6-d3d3387cc49a | 2024-12-18 | Warnings | 451W47IQ8X |
| Mast Cell Pro | HYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM, | Energique, Inc. | 5cd31e1d-0312-48d1-9ecd-d01c6fe3b672 | 2024-12-11 | Warnings | 451W47IQ8X |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | 059QF0KO0R |
| Ventrixyl | FOLIC ACID | PureTek Corporation | c29dc729-93be-2a20-e053-2a95a90a8ca3 | 2024-12-03 | Warnings, Adverse reactions | 25X51I8RD4 |
| Junior Moves | ANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB MET | Silver Star Brands | 822d5481-7854-3fe7-e053-2a91aa0abf55 | 2024-12-03 | Warnings | 451W47IQ8X |
| Migo-Ease | ACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLA | Silver Star Brands | 816837f5-4487-657d-e053-2991aa0a78f4 | 2024-12-03 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 464c2d78-5c88-4668-a039-56dd3c1c9b20 | 2024-12-03 | 451W47IQ8X | |
| Folitin-Z | FERROUS FUMARATE, FOLIC ACID | PureTek Corporation | bb141ac2-e5df-4df4-e053-2995a90a6e72 | 2024-12-02 | Warnings, Adverse reactions | 25X51I8RD4 |
| XX Health Pro | LACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHUR | Silver Star Brands | 4d11a65e-696a-0727-e054-00144ff88e88 | 2024-12-02 | Warnings | 451W47IQ8X |
| Davimet with Iron | IRON, FOLATE | PureTek Corporation | 1445921b-5bf4-ea48-e063-6294a90abb1a | 2024-11-27 | Warnings, Adverse reactions | 25X51I8RD4 |
| Foliflex | FERROUS FUMARATE, FOLIC ACID | PureTek Corporation | cba98d1a-8cf9-39d9-e053-2995a90ae8bb | 2024-11-27 | Warnings, Adverse reactions | 25X51I8RD4 |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | 451W47IQ8X |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.