FDA.reportPublic FDA data

NDC 49315-005-01 - Arsenic trioxide

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
49315-005
Requested NDC
49315-005-01
Package NDCs from labels
49315-005-01, 49315-005-10
Manufacturer
Zydus Lifesciences Limited
Effective date
2022-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arsenic trioxide - Zydus Lifesciences LimitedZydus Lifesciences Limited2022-11-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49315-005-01Arsenic trioxide10 mL in 1 VIALINJECTION, SOLUTION103
49315-005-10Arsenic trioxide10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49315-005ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 2 package rows20221108_25e8295c-b5d9-4322-a093-d907ab1d1d35.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.

Matched openFDA labels page 16 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dust Mix AntigensARSENICUM ALBUM, DROSERA (ROTUNDIFOLIA), LYCOPODIUM CLAVATUM, POTHOS FOETIDUS, PULSATILLA (PRATENSIS), BARLEY, CORN, HOUSE, MILLET, MILO, OAT, RICE, CARPET, FURNITURE, WHEATBioActive Nutritional, Inc.6f0e22e2-92be-4a66-95aa-692260f01fa62025-04-03WarningsExact identifier
unii: S7V92P67HO
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Respiforce AARNICA MONTANA, ASCLEPIAS TUBEROSA, ERIODICTYON CALIFORNICUM, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, PLANTAGO MAJOR, TRIFOLIUM PRATENSE, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CARBO VEGETABILIS, GRINDELIA, KALI CARBONICUM, NATRUM SULPHURICUM, PULSATILLA,BioActive Nutritionale9360698-bffb-4c91-b019-22e1e56704ee2025-04-02WarningsExact identifier
unii: S7V92P67HO
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e92025-03-20WarningsExact identifier
unii: S7V92P67HO
ARSENIC TRIOXIDEARSENIC TRIOXIDENordic Pharma, Inc.d1e2107c-26c3-40fc-978e-0ba5b84098ac2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829926
unii: S7V92P67HO
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.2b691b17-296b-49d2-924e-c62522d4b9a72025-03-20WarningsExact identifier
unii: S7V92P67HO
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: S7V92P67HO
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: S7V92P67HO
DiarrheaCalmARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, PODOPHYLLUMBoiron302786a1-c6a2-f7ea-e063-6394a90a327b2025-03-12Exact identifier
unii: S7V92P67HO
DiarrheaCalmARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, PODOPHYLLUMBoiron30293788-e30b-d650-e063-6394a90a95172025-03-12Exact identifier
unii: S7V92P67HO
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, RHUS TOX, PYROGENIUM, INFLUENZINUM (2023-2024)Energique, Inc.c0ef1647-22f9-4cfa-a7e6-90c47c93dbde2025-03-11WarningsExact identifier
unii: S7V92P67HO
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: S7V92P67HO
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM (2021-2022), LACHESIS MUTUS, RHUS TOX, PYROGENIUMEnergique, Inc.9ec6f663-5f15-4daf-a36b-49fbe1c53a6c2025-03-11WarningsExact identifier
unii: S7V92P67HO
Arsenicum Album 30XARSENICUM ALBUM 30XTrue Botanica, LLC2e20f4b5-13a9-306a-e063-6394a90abc142025-03-10WarningsExact identifier
unii: S7V92P67HO
Bestmade Natural Products BM252VISCUM ALB, CRATAEGUS OXY, BARYTA CARB, AURUM MUR, ARS ALB, ARUM LOD, BARYTA LODATABestmade Natural Products2fa96793-7ede-5f2e-e063-6294a90a83c62025-03-06WarningsExact identifier
unii: S7V92P67HO
BART PLUSACONITUM NAPELLUS, APIS MELLIFICA, ARBUTUS ANDRACHNE, ARNICA MONTANA, ARSENICUM ALBUM, COCCULUS INDICUS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, GUNPOWDER, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALMIA LATIFOLIA, LAC CANINUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, STRAMONIUM, TELLURIUM METALLICUM, THYROIDINUM (SUIS), VERATRUM ALBUMDeseret Biologicals, Inc.4de3d6d4-108c-41b9-8aa7-4225ce494d782025-03-04WarningsExact identifier
unii: S7V92P67HO
Bestmade Natural Products BM234ACONITE, ARS. ALB, BELLADONNA, BRYONIA, EUP. PERF, GELSEMIUM, PYROGENUMBestmade Natural Products2f825212-ff1f-6037-e063-6394a90a0fca2025-03-04WarningsExact identifier
unii: S7V92P67HO
Bestmade Natural Products BM240AGRIMONIA, ARSENIC ALBUM, CIMICIFUGA, GRAPHITE, HYDRASTIS CAN, KALI BICH, KREOSOTUM, NITRICUM ACIDUMBestmade Natural Products2f83481b-e95f-c002-e063-6394a90a1d382025-03-04WarningsExact identifier
unii: S7V92P67HO
Arsenic TrioxideARSENIC TRIOXIDENexus Pharmaceuticals LLC2b2a7ed9-5ed3-42fc-b19b-d507003962332025-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829926
unii: S7V92P67HO
Bestmade Natural Products BM212ARS ALB, KALI PHOS, NAT CARB, NITRIC ACIDBestmade Natural Products2f37416e-b3af-f980-e063-6294a90a6be12025-02-28WarningsExact identifier
unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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