FDA.reportPublic FDA data

5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]

RxCUI
1737762
RxNorm name
5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]
Display name
XYLOCAINE (Injectable)
Full name
5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]
Term type
SBD
Status
Active
Strength
100 mg/5ml
Dose form
Injection 5 ml
Route
Injectable
Updated
2026-10-21 07:30:44

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 hydrochloride20 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_STR5 ML Xylocaine 20 MG/ML Injection1NAMES
RxNorm Name5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
5 linked values
5CODES
RxCUI17377621CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
51662-1604-351662-1604XYLOCAINE- MPF (LIDOCAINE HCl ) LIDOCAINE HClHF Acquisition Co LLC, DBA HealthFirstNDA006488
63323-495-0763323-495Xylocaine LIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA006488
63323-495-2663323-495Xylocaine LIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA006488
65219-814-0565219-814Xylocaine LIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA006488
85766-256-2585766-256Xylocaine LIDOCAINE HYDROCHLORIDESportpharm LLCNDA006488

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA00648851662-1604XYLOCAINE- MPF (LIDOCAINE HCl ) LIDOCAINE HClNDAHF Acquisition Co LLC, DBA HealthFirst

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 15 matching rows.

NDC11, Source, Active table
NDC11SourceActive
51662160402rxnav_ndcsyes
51662160403rxnav_ndcsyes
63323049504rxnav_ndcsyes
63323049507rxnav_ndcsyes
63323049526rxnav_ndcsyes
63323049541rxnav_ndcsyes
63323049889rxnav_ndcsyes
65219081401rxnav_ndcsyes
65219081405rxnav_ndcsyes
85766025601rxnav_ndcsyes
85766025625rxnav_ndcsyes
00186023203rxnav_historical
00186024213rxnav_historical
55154939605rxnav_historical
70518160000rxnav_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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsExact identifier
ndc (package): 85766-256-25
ndc (product): 85766-256
ndc11 (package): 85766025625
ndc11 (package): 85766025601
rxcui: 1737762
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLC4dd52202-8eef-4136-92dd-ada573b7cf742025-04-22Warnings, Adverse reactionsExact identifier
ndc (package): 63323-495-26
ndc (product): 63323-495
ndc11 (package): 63323049541
ndc11 (package): 63323049526
rxcui: 1737762
Xylocaine MPFLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCfe265eb5-eaeb-4f47-82dd-238c1d53fec42024-03-15Warnings, Adverse reactionsExact identifier
ndc (package): 65219-814-05
ndc (product): 65219-814
ndc11 (package): 65219081401
ndc11 (package): 65219081405
rxcui: 1737762
XYLOCAINE- MPF (LIDOCAINE HCl )LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste8b987c8-b5cb-74cd-e053-2a95a90a5a932024-01-27Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1604-3
ndc (product): 51662-1604
ndc11 (package): 51662160402
ndc11 (package): 51662160403
rxcui: 1737762
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
ndc (package): 63323-495-07
ndc (product): 63323-495
ndc11 (package): 63323049507
ndc11 (package): 63323049504
rxcui: 1737762

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine 2 % in 5 ML Injection [PSN] · 5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine] [SBD] · 5 ML Xylocaine 20 MG/ML Injection [SY] · Xylocaine-MPF 100 MG per 5 ML Injection [SY] · Xylocaine-MPF 2 % per 5 ML Injection [SY]513Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825
4dd52202-8eef-4136-92dd-ada573b7cf74Xylocaine 2 % in 5 ML Injection [PSN] · 5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine] [SBD] · 5 ML Xylocaine 20 MG/ML Injection [SY] · Xylocaine-MPF 100 MG per 5 ML Injection [SY] · Xylocaine-MPF 2 % per 5 ML Injection [SY]57Xylocaine ® Xylocaine ® (lidocaine HCl Injection, USP) Xylocaine ® (lidocaine HCl and epinephrine Injection, USP)20250422
fe265eb5-eaeb-4f47-82dd-238c1d53fec4Xylocaine 2 % in 5 ML Injection [PSN] · 5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine] [SBD] · 5 ML Xylocaine 20 MG/ML Injection [SY] · Xylocaine-MPF 100 MG per 5 ML Injection [SY] · Xylocaine-MPF 2 % per 5 ML Injection [SY]53Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20240315
e8b987c8-b5cb-74cd-e053-2a95a90a5a93Xylocaine 2 % in 5 ML Injection [PSN] · 5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine] [SBD] · 5 ML Xylocaine 20 MG/ML Injection [SY] · Xylocaine-MPF 100 MG per 5 ML Injection [SY] · Xylocaine-MPF 2 % per 5 ML Injection [SY]52XYLOCAINE®- MPF (LIDOCAINE HCl INJECTION, USP) 2% 100mg/5mL (20mg/mL)20240127

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
50aa6133-0776-4714-9821-fe8581f635caXylocaine ® (lidocaine HCl Injection, USP)Sportpharm LLC | ASCLEMED USA INC. DBA ENOVACHEM20260728
4dd52202-8eef-4136-92dd-ada573b7cf74Xylocaine ® Xylocaine ® (lidocaine HCl Injection, USP) Xylocaine ® (lidocaine HCl and epinephrine Injection, USP)Fresenius Kabi USA, LLC20250422
fe265eb5-eaeb-4f47-82dd-238c1d53fec4Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)Fresenius Kabi USA, LLC20240315
e8b987c8-b5cb-74cd-e053-2a95a90a5a93XYLOCAINE®- MPF (LIDOCAINE HCl INJECTION, USP) 2% 100mg/5mL (20mg/mL)HF Acquisition Co LLC, DBA HealthFirst20240127
4dd52202-8eef-4136-92dd-ada573b7cf74Xylocaine ® Xylocaine ® (lidocaine HCl Injection, USP) Xylocaine ® (lidocaine HCl and epinephrine Injection, USP)Fresenius Kabi USA, LLC20220915
ba082c2f-64f4-419d-9c88-74f203316e17Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)Fresenius Kabi USA, LLC | Fresenius Kabi Austria20210825
ebf5c984-35cb-4139-8668-44da24872f99XylocaineREMEDYREPACK INC.20181026
45547802-d87e-4057-bfda-bebd10558002National Council for Prescription Drug Programs20120724
7af59ba6-f9b8-4b34-b427-7c24896ae3b5National 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_STRENGTH20 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY5 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA006488
NAMESPrescribable SynonymXylocaine 2 % in 5 ML Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon