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 table
LabelManufacturerEffective dateType
XynthaWyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA | Pfizer Ireland Pharmaceuticals Unlimited Company2026-03-16PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58394-124-03Xyntha4 mL in 1 SYRINGEINJECTION, POWDER, LYOPHILIZED,4 mL1000 [iU] in 4mL35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58394-124XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]34Unmatched20250119_25ea1c3c-14a2-ef11-302e-012bd683924f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETEDACTIVE INGREDIENT113E3Z3CJJXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETEDACTIVE MOIETY113E3Z3CJJXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
HISTIDINEINACTIVE INGREDIENT4QD397987EXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
SUCROSEINACTIVE INGREDIENTC151H8M554XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
WATERINACTIVE INGREDIENT059QF0KO0RXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19

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 47 of 91 · 1,811 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: ND2M416302
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
WISH RUBBING ALCOHOL 99%ISOPROPYL ALCOHOLLJ Pharmaa06953d7-d685-45ac-b1c6-e66dc7a05bca2025-06-18WarningsExact identifier
unii: ND2M416302
Calcium ChlorideCALCIUM CHLORIDE INJECTIONMedefil, Inc.90b8936e-61f2-5318-e053-2995a90aac442025-06-17Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC1fdff866-f534-4c16-b755-b2efd1e6e8372025-06-17WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 99% WINTERGREENISOPROPYL ALCOHOLLJ Pharmade7b2253-7f36-4a27-8838-442ec635f69b2025-06-16WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70% WINTERGREENISOPROPYL ALCOHOLLJ Pharma98ebf7a7-7c13-4feb-90b5-21cc6dab99f62025-06-16WarningsExact identifier
unii: ND2M416302
HAND-I-SAN75% ISOPROPYL ALCOHOL HAND SANITIZERZECO, LLC37627a51-cf31-013c-e063-6294a90ae13a2025-06-13WarningsExact identifier
unii: ND2M416302
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 451W47IQ8X
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Travel WipesISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC818b4280-a1cb-4c69-908f-f687f7c84ad92025-06-06WarningsExact identifier
rxcui: 797544
unii: ND2M416302
MBM 7 LungCOCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUMThe Wellness Center for Research and Education, Inc.6eb49fb5-485c-4b48-b231-4db88ebe20df2025-06-04WarningsExact identifier
unii: 451W47IQ8X
The Pharma-C Company 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLKleen Test Products Corporationa0f93dac-7baa-4f79-b6a0-3cabe52806bb2025-06-04WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Marbeta L KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAdvanced Rx of Tennessee, LLC369a6210-907f-3126-e063-6394a90a0d8f2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHHUZHOU JUNDA INDUSTRY CO., LTD.361dcd60-c194-4c8b-e063-6294a90a425b2025-05-27WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.d397ed9c-10f0-4a99-baca-a31e5e18572a2025-05-27WarningsExact identifier
unii: 451W47IQ8X
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2023-2024), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.1d35a8ab-c06b-478d-8f7b-dbe9c7dbb3d42025-05-27WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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