FDA.reportPublic FDA data

lidocaine hydrochloride 41.2 MG/ML Topical Cream

RxCUI
1947197
RxNorm name
lidocaine hydrochloride 41.2 MG/ML Topical Cream
Display name
Lidocaine (Topical)
Full name
lidocaine hydrochloride 41.2 MG/ML Topical Cream
Term type
SCD
Status
Active
Strength
4.12%
Dose form
Cream
Route
Topical
Updated
2026-10-30 15:34:10

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112017
Active start
112017
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride41.2 MG / 1 MLlidocainelidocaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRlidocaine hydrochloride 41.2 MG/ML Topical Cream1NAMES
RxNorm Namelidocaine hydrochloride 41.2 MG/ML Topical Cream1NAMES
RxNorm Synonymlidocaine HCl 4.12 % Topical Cream1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI19471971CODES
MMSL_CODEBD408531CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59088-321-0759088-321Neurozyl Lidocaine HCl 4.12 %PureTek Corporation
59088-594-0359088-594PharmapureRx Lidocaine HCl 4.12% Lidocaine HydrochloridePureTek Corporation
59088-594-0759088-594PharmapureRx Lidocaine HCl 4.12% Lidocaine HydrochloridePureTek Corporation

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
59088032107rxnav_ndcsyes
59088059403rxnav_ndcsyes
59088059407rxnav_ndcsyes
73352061001rxnav_ndcsyes
59088042903rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrilocaineLIDOCAINE HYDROCHLORIDETrifluent Pharma LLCc58257bf-f06b-48d1-92df-a680dbd5eea02025-10-15Warnings, Adverse reactionsExact identifier
ndc11 (package): 73352061001
rxcui: 1947197
NeurozylLIDOCAINE HCL 4.12 %PureTek Corporation1aca46c8-ff06-da0e-e063-6394a90a475f2024-06-13Warnings, Adverse reactionsExact identifier
ndc (package): 59088-321-07
ndc (product): 59088-321
ndc11 (package): 59088032107
rxcui: 1947197
PharmapureRx Lidocaine HCl 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationb7a77ad1-821b-4388-a97c-aadb1340c5362023-01-11Warnings, Adverse reactionsExact identifier
ndc (package): 59088-594-07
ndc (package): 59088-594-03
ndc (product): 59088-594
ndc11 (package): 59088059407
ndc11 (package): 59088059403
rxcui: 1947197
Lydexa 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationaa1c9d39-1283-8c6b-e053-2a95a90af5b52022-03-02Warnings, Adverse reactionsExact identifier
ndc11 (package): 59088042903
rxcui: 1947197

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
aa1c9d39-1283-8c6b-e053-2a95a90af5b5lidocaine HCl 4.12 % Topical Cream [PSN] · lidocaine hydrochloride 41.2 MG/ML Topical Cream [SCD] · lidocaine HCl 4.12 % Topical Cream [SY]35Lydexa 4.12% Cream (Lidocaine HCl) Topical Anesthetic Rx Only20220302
b7a77ad1-821b-4388-a97c-aadb1340c536lidocaine HCl 4.12 % Topical Cream [PSN] · lidocaine hydrochloride 41.2 MG/ML Topical Cream [SCD] · lidocaine HCl 4.12 % Topical Cream [SY]34PharmaPureRx ® Lidocaine HCl 4.12% Cream (Lidocaine HCl) Topical Anesthetic Rx Only20230111
c58257bf-f06b-48d1-92df-a680dbd5eea0lidocaine HCl 4.12 % Topical Cream [PSN] · lidocaine hydrochloride 41.2 MG/ML Topical Cream [SCD] · lidocaine HCl 4.12 % Topical Cream [SY]33Trilocaine™ 4.12% Cream (Lidocaine HCl) Topical Anesthetic20251015
1aca46c8-ff06-da0e-e063-6394a90a475flidocaine HCl 4.12 % Topical Cream [PSN] · lidocaine hydrochloride 41.2 MG/ML Topical Cream [SCD] · lidocaine HCl 4.12 % Topical Cream [SY]31Neurozyl Cream20240613

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c58257bf-f06b-48d1-92df-a680dbd5eea0Trilocaine™ 4.12% Cream (Lidocaine HCl) Topical AnestheticTrifluent Pharma LLC20251015
c58257bf-f06b-48d1-92df-a680dbd5eea0Trilocaine™ 4.12% Cream (Lidocaine HCl) Topical AnestheticTrifluent Pharma LLC20251015
c58257bf-f06b-48d1-92df-a680dbd5eea0Trilocaine™ 4.12% Cream (Lidocaine HCl) Topical AnestheticTrifluent Pharma LLC20240614
1aca46c8-ff06-da0e-e063-6394a90a475fNeurozyl CreamPureTek Corporation20240613
b7a77ad1-821b-4388-a97c-aadb1340c536PharmaPureRx ® Lidocaine HCl 4.12% Cream (Lidocaine HCl) Topical Anesthetic Rx OnlyPureTek Corporation20230111
aa1c9d39-1283-8c6b-e053-2a95a90af5b5Lydexa 4.12% Cream (Lidocaine HCl) Topical Anesthetic Rx OnlyPureTek Corporation20220302
fc68707c-c0ba-4c2b-a562-804fa988f22fThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993PureTek Corporation20190508
d527f6fe-c997-4de0-9f35-053cd81e15b7These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993PureTek Corporation20190430

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_STRENGTH41.2 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymlidocaine HCl 4.12 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon