FDA.reportPublic FDA data

50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine]

RxCUI
1737345
RxNorm name
50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine]
Display name
XYLOCAINE (Injectable)
Full name
50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine]
Term type
SBD
Status
Active
Strength
5 mg/ml
Dose form
Injection 50 ml
Route
Injectable
Updated
2026-10-21 00:32:00

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032016
Active start
032016
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride5 MG / 1 MLlidocainelidocaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR50 ML Xylocaine 5 MG/ML Injection1NAMES
RxNorm Name50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI17373451CODES
MMSL_CODEBD149401CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
51662-1653-151662-1653XYLOCAINE MPF lidocaine hydrochlorideHF Acquisition Co LLC, DBA HealthFirstNDA006488
63323-491-5763323-491Xylocaine LIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA006488

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA00648851662-1653XYLOCAINE MPF lidocaine hydrochlorideNDAHF Acquisition Co LLC, DBA HealthFirst

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
51662165301rxnav_ndcsyes
63323049101rxnav_ndcsyes
63323049157rxnav_ndcsyes
00186013701rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1986c302-82a0-95a9-e063-6294a90a33392026-09-02Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1653-1
ndc (product): 51662-1653
ndc11 (package): 51662165301
rxcui: 1737345
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
ndc (package): 63323-491-57
ndc (product): 63323-491
ndc11 (package): 63323049101
ndc11 (package): 63323049157
rxcui: 1737345

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine] [SBD] · 50 ML Xylocaine 5 MG/ML Injection [SY] · Xylocaine-MPF 0.5 % per 50 ML Injection [SY] · Xylocaine-MPF 250 MG per 50 ML Injection [SY]513Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825
1986c302-82a0-95a9-e063-6294a90a3339Xylocaine 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine] [SBD] · 50 ML Xylocaine 5 MG/ML Injection [SY] · Xylocaine-MPF 0.5 % per 50 ML Injection [SY] · Xylocaine-MPF 250 MG per 50 ML Injection [SY]5320241115

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
1986c302-82a0-95a9-e063-6294a90a3339HF Acquisition Co LLC, DBA HealthFirst20260902
1986c302-82a0-95a9-e063-6294a90a3339HF Acquisition Co LLC, DBA HealthFirst20241115
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)Fresenius Kabi USA, LLC | Fresenius Kabi Austria20210825
d9fb693a-ca08-4f1b-8821-286e0d210d43National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN01BBAmidesATC1-4lidocaine
ATCS02DAAnalgesics and anestheticsATC1-4lidocaine
ATCD04ABAnesthetics for topical useATC1-4lidocaine
ATCR02ADAnesthetics, localATC1-4lidocaine
ATCC01BBAntiarrhythmics, class IbATC1-4lidocaine
ATCS01HALocal anestheticsATC1-4lidocaine
ATCC05ADLocal anestheticsATC1-4lidocaine
FDASPLN0000175682Amide Local AnestheticEPChas_epclidocaine
FDASPLN0000175426AntiarrhythmicEPChas_epclidocaine
FDASPLN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine hydrochloride
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine hydrochloride
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD002056BurnsDISEASEmay_treatlidocaine hydrochloride
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD009203Myocardial InfarctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine hydrochloride
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine
MEDRTD018754Ventricular DysfunctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine hydrochloride
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine hydrochloride
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine hydrochloride
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY50 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA006488
NAMESPrescribable SynonymXylocaine 0.5 % in 50 ML Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon