NDC 58394-124 - Xyntha
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
- 58394-124
- Package NDCs from labels
- 58394-124-03
- Manufacturer
- Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA | Pfizer Ireland Pharmaceuticals Unlimited Company
- Effective date
- 2026-03-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Xyntha | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA | Pfizer Ireland Pharmaceuticals Unlimited Company | 2026-03-16 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58394-124-03 | Xyntha | 4 mL in 1 SYRINGE | INJECTION, POWDER, LYOPHILIZED, | 4 mL | 1000 [iU] in 4mL | 35 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| AllergiClear-M | ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA | Silver Star Brands | 9d36096b-022f-5cfa-e053-2995a90a381f | 2025-01-01 | Warnings | 451W47IQ8X |
| ALCOHOL PREP PADS MEDIUM STERILE | ISOPROPYL ALCOHOL CLOTH | JINHUA JINGDI MEDICAL SUPPLIES CO., LTD | 303097a0-8eb0-3e1c-e063-6394a90afab3 | 2025-01-01 | Warnings | 797544 ND2M416302 |
| BL-C Kit | BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINE | Asclemed USA, Inc. | 798f3bc6-d976-49a6-87a2-fd30c784fc50 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| DG Health Sterile Saline Mist | SODIUM CHLORIDE | DG Health | f2e44ab4-ae0f-c87b-e053-2a95a90acd04 | 2024-12-31 | Warnings | 451W47IQ8X |
| Ketorocaine LM Kit | KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE | Advanced Rx Pharmacy of Tennessee, LLC | fb81d452-30e0-f019-e053-6394a90a7634 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| Multi-Specialty Kit | DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL | Advanced Rx Pharmacy of Tennessee, LLC | fb85b480-d0cd-2539-e053-6294a90a5083 | 2024-12-31 | Warnings, Adverse reactions | 797544 |
| DoubleDex Kit | DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE | Advanced Rx Pharmacy of Tennessee, LLC | fb85dd2c-6c90-6249-e053-6294a90a09fa | 2024-12-31 | Warnings, Adverse reactions | 797544 |
| Betalido Kit | BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, POVIDINE IODINE | Advanced Rx Pharmacy of Tennessee, LLC | fb5d3ec8-8866-881d-e053-6294a90a1cc5 | 2024-12-31 | Warnings, Adverse reactions | 797544 |
| Dyural 80-LM | METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL | Advanced Rx Pharmacy of Tennessee, LLC | 01ca7a2d-e8cb-c063-e063-6294a90ae7f9 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| Dyural 80 Kit | METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL | Advanced Rx Pharmacy of Tennessee, LLC | 01ca2f07-9c84-e418-e063-6294a90ac760 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| Dyural 40 Kit | METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL | Advanced Rx Pharmacy of Tennessee, LLC | 01ca16de-ab2e-4e19-e063-6394a90a0510 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 797544 |
| COVISIDE HAND SANITIZER | ISOPROPYL ALCOHOL | CREAGEN INC | a9f07fcd-4d5c-362c-e053-2a95a90a2e79 | 2024-12-30 | Warnings | ND2M416302 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | R&C Imports LLC | 4e3fe418-d1d9-3024-e054-00144ff88e88 | 2024-12-27 | Warnings | 797544 ND2M416302 |
| Gut Brain Spectrum | ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | adfee6ce-05b0-4955-bf5f-9612b8db4c78 | 2024-12-26 | Warnings | C151H8M554 451W47IQ8X |
| TREE ANTIGEN | POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE | Natural Creations, Inc | 8040ab36-90eb-4076-a478-9b82ccfa4ec9 | 2024-12-23 | Warnings | 451W47IQ8X |
| Sterile Hypertonic Saline Solution 7 Sodium Chloride | SODIUM CHLORIDE | JOONEM LLC | e7110525-9f9b-5b68-e053-2995a90ac034 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | 49309411-9af4-4f19-a3bf-dbeabc106827 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | ba0868f6-d3de-40e2-bcb3-144fa53062c7 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | 9d83f477-ebbc-4248-8445-769178181d4f | 2024-12-23 | Warnings | 451W47IQ8X |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | New Pride Corp | f0f12204-2948-1357-e053-2995a90ae50a | 2024-12-19 | Warnings | ND2M416302 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.