FDA.reportPublic FDA data

NDC 54879-027-10 - 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
54879-027
Requested NDC
54879-027-10
Package NDCs from labels
54879-027-10, 54879-027-11
Manufacturer
STI Pharma LLC
Effective date
2022-11-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arsenic Trioxide - STI Pharma LLCSTI Pharma LLC2022-11-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54879-027-112025-04-21C16284748780-1ab0e2407-30bb-f274-e053-dbdaa90a6471Arsenic trioxide injection, for intravenous administration These highlights do not include all the information needed to use Arsenic Trioxide safely and effectively. See full prescribing information for Arsenic Trioxide . Initial U.S. Approval: 2000
54879-027-112024-01-30C16284748780-1ab0e2407-30bb-f274-e053-dbdaa90a6471Arsenic trioxide injection, for intravenous administration These highlights do not include all the information needed to use Arsenic Trioxide safely and effectively. See full prescribing information for Arsenic Trioxide . Initial U.S. Approval: 2000
54879-027-112020-07-22C16284748780-1ab0e2407-30bb-f274-e053-dbdaa90a6471Arsenic trioxide injection, for intravenous administration These highlights do not include all the information needed to use Arsenic Trioxide safely and effectively. See full prescribing information for Arsenic Trioxide . Initial U.S. Approval: 2000

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 45 · 893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
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
Arsenic TrioxideARSENIC TRIOXIDENexus Pharmaceuticals LLC2b2a7ed9-5ed3-42fc-b19b-d507003962332025-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: S7V92P67HO
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.e9d27f88-de82-4379-b143-4b94b3dd8bbe2025-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.e1ad5d87-e65e-402f-86b5-e641fc4e61ab2025-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: S7V92P67HO
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Arsenicum Album 200ckARSENIC TRIOXIDESEVENE USAc8d6dcbf-a5a9-5231-e053-2a95a90a73542025-02-11WarningsExact identifier
unii: S7V92P67HO
Stage Fright-FearACONITUM NAP., ANACARDIUM, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOS., SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.2df84360-dfff-9851-e063-6394a90ad7902025-02-11WarningsExact identifier
unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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