FDA.reportPublic FDA data

lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]

RxCUI
1010902
RxNorm name
lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]
Display name
XYLOCAINE (Injectable)
Full name
lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]
Term type
SBD
Status
Active
Strength
5 mg/ml
Dose form
Sol
Route
Injectable
Updated
2026-06-17 07:02:37

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
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
Injectable Solution316949

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRXylocaine 0.5 % Injectable SolutionNAMES
RxNorm Namelidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]NAMES
RxNorm SynonymXylocaine 0.5 % Injectable SolutionNAMES
RxNorm SynonymXylocaine 5 MG/ML Injectable SolutionNAMES
TTYSBDATTRIBUTES
SPL_SET_IDba082c2f-64f4-419d-9c88-74f203316e17CODES
RxCUI1010902CODES
MMSL_CODEBD1768CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63323-484-5763323-484Xylocaine LIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA006488

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA00648863323-484Xylocaine LIDOCAINE HYDROCHLORIDENDAFresenius Kabi USA, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

NDC11, Source, Active table
NDC11SourceActive
63323048457rxnav_ndcsyes
00186013501rxnav_historical
00186013701rxnav_historical
52584048457rxnav_historical
54569391700rxnav_historical
54868339200rxnav_historical
54868429800rxnav_historical
55154956508rxnav_historical
63323048450rxnav_historical
63323049150rxnav_historical
63323049157rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
ndc (package): 63323-484-57
ndc (product): 63323-484
ndc11 (package): 63323049157
ndc11 (package): 63323048457
rxcui: 1010902

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine 0.5 % Injectable SolutionPSN13Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine 5 MG/ML Injectable SolutionSY13Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine 0.5 % Injectable SolutionSY13Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825
ba082c2f-64f4-419d-9c88-74f203316e17lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]SBD13Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)Fresenius Kabi USA, LLC | Fresenius Kabi Austria20210825
58215e57-754d-484b-81a4-3ed8dd8144b9Xylocaine 5mg/mLGeneral Injectables & Vaccines, Inc20191125
3aa95514-e260-4d41-bc45-ef577223372cNational Council for Prescription Drug Programs20120724
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
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD1768
CODESNDANDA006488
CODESRxCUI1010902
CODESSPL_SET_IDba082c2f-64f4-419d-9c88-74f203316e17
NAMESPrescribable SynonymXylocaine 0.5 % Injectable Solution
NAMESRXNAV_STRXylocaine 0.5 % Injectable Solution
NAMESRxNorm Namelidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]
NAMESRxNorm SynonymXylocaine 0.5 % Injectable Solution
NAMESRxNorm SynonymXylocaine 5 MG/ML Injectable Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon