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 42 of 57 · 1,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Citanest Forte DENTALPRILOCAINE HCL AND EPINEPHRINEDentsply Pharmaceutical Inc.60c8710b-ae55-4fdf-e053-2991aa0adc752024-02-29Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
EPST PLUSCARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLADeseret Biologicals, Inc.c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc252024-02-27WarningsExact identifier
unii: 451W47IQ8X
unii: QTT17582CB
LIDOCAINE HCI AND EPINEPHRINELIDOCAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst957506a5-1b09-0736-e053-2995a90a0b632024-02-26Warnings, Adverse reactionsExact identifier
rxcui: 1010751
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta098ab6c-143f-77a5-e053-2a95a90a3e0a2024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 1010759
LIDOCAINE HCI AND EPINEPHRINELIDOCAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta0997348-6274-060a-e053-2a95a90abea72024-02-22Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1010759
unii: 30Q7KI53AK
unii: EC2CNF7XFP
LIDOCAINE HCI AND EPINEPHRINELIDOCAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09af094-7cfc-1d47-e053-2a95a90a6b692024-02-22Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1010759
unii: 30Q7KI53AK
unii: EC2CNF7XFP
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirstc1735498-0721-687c-e053-2a95a90a47f42024-02-19Warnings, Adverse reactionsExact identifier
rxcui: 1737562
VivacaineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont, Inc.b4c60d8e-e350-45b2-9d6b-5815eeb6c9942024-02-16Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Lidocaine HemorrhoidLIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZELWalgreens Co10a47899-f4a0-66e8-e063-6394a90a11dd2024-02-05WarningsExact identifier
unii: EC2CNF7XFP
Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.93cf0914-de08-4ec6-8f8c-d663243b99582024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst8c63be55-5de4-7f72-e053-2995a90a102e2024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1737761
BUPIVACAINE HCI AND EPINEPHRINEBUPIVACAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst99516811-56e2-9c8a-e053-2a95a90ac9cb2024-01-30Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst946ce625-3647-5083-e053-2a95a90a1ebc2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999dd95d-87fe-12c0-e053-2995a90aa9f72024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1010033
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst993bc59e-5e71-bd9e-e053-2a95a90af85c2024-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1737761
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1010671
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirste3b3b462-8f35-68b8-e053-2995a90a64032024-01-27Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1010033
unii: EC2CNF7XFP
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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