NDC 63323-481-01 - Xylocaine

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
63323-481
Requested NDC
63323-481-01
Package NDCs from labels
63323-481-01, 63323-481-57
Manufacturer
Henry Schein, Inc
Effective date
2025-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Xylocaine - Henry Schein, IncHenry Schein, Inc2025-08-07HUMAN PRESCRIPTION DRUG LABEL
Xylocaine - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-22HUMAN PRESCRIPTION DRUG LABEL
Xylocaine MPF - Fresenius Kabi USA, LLC | Fresenius Kabi AustriaFresenius Kabi USA, LLC | Fresenius Kabi Austria2021-08-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-481-01Xylocaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5013
63323-481-57Xylocaine25 in 1 TRAYINJECTION, SOLUTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-481XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]13Current NDC, Legacy NDC, 2 package rows20210831_ba082c2f-64f4-419d-9c88-74f203316e17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-481-57ML - Milliliter63323-48127e8b3c9-2007-4f4b-ba9e-56cc304eebbf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
EPINEPHRINEACTIVE MOIETYYKH834O4BHXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINEACTIVE MOIETY98PI200987XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
Epinephrine BitartrateACTIVE INGREDIENT30Q7KI53AKXYLOCAINE (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AXYLOCAINE (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
EpinephrineACTIVE MOIETYYKH834O4BHXYLOCAINE (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
LidocaineACTIVE MOIETY98PI200987XYLOCAINE (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1

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 43 of 57 · 1,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstc901016e-9293-79dd-e053-2a95a90a0fda2024-01-27Warnings, Adverse reactionsExact identifier
rxcui: 1737761
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste39435a3-1f69-78c5-e053-2995a90a7fc32024-01-27Warnings, Adverse reactionsExact identifier
rxcui: 1737568
0.5% LIDOCAINE HCl0.5% LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste52fe254-8872-35ce-e053-2a95a90a339e2024-01-27Warnings, Adverse reactionsExact identifier
rxcui: 1737343
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
XYLOCAINE- MPF (LIDOCAINE HCl )LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste8b987c8-b5cb-74cd-e053-2a95a90a5a932024-01-27Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1737761
rxcui: 1737762
unii: EC2CNF7XFP
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CIRCULATION HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA,Energique, Inc.464d208b-3893-4ec6-9868-12ef6807b98d2024-01-23WarningsExact identifier
unii: 451W47IQ8X
DERMA SCALE HPARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUREnergique, Inc.64961787-7e9a-4e6f-98ce-0f51934155cf2024-01-23WarningsExact identifier
unii: 451W47IQ8X
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst971439ed-4507-7a30-e053-2a95a90a1f1c2024-01-22Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1867943
unii: 30Q7KI53AK
unii: EC2CNF7XFP
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINELIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst94e9f2db-af29-032e-e053-2995a90a7f7b2024-01-22Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1868028
unii: 30Q7KI53AK
unii: EC2CNF7XFP
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst995e68a7-6986-423e-e053-2995a90acd982024-01-22Warnings, Adverse reactionsExact identifier
rxcui: 1737761
rxcui: 1737566
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirst0c6c5678-e987-b822-e063-6394a90ac88b2024-01-22Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1010033
unii: EC2CNF7XFP
Energy ComplexECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Health Masters LLC9286ca29-8190-4867-9231-b0d68180cb102024-01-22WarningsExact identifier
unii: 451W47IQ8X
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
unii: EC2CNF7XFP
Sodium ChlorideSODIUM CHLORIDESpectra Medical Deviecs, LLC7e316d21-d6ad-4976-bd90-268fd7e513612024-01-12Adverse reactionsExact identifier
unii: 451W47IQ8X
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSSpectra Medical Devices, LLCe8ba012a-08a9-4f67-9f88-3284377e80be2024-01-12Warnings, Adverse reactionsExact identifier
rxcui: 1737566
unii: EC2CNF7XFP
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: 451W47IQ8X
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: 451W47IQ8X
B07 DPRSN ANTITOXADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWERApex Energetics Inc.bd1fbb76-4f6f-7098-e053-2a95a90ae25c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
B13 CELL SALT COMPLEXALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENSApex Energetics Inc.bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d2024-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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