FDA.reportPublic FDA data

lidocaine 0.04 MG/MG Topical Gel [Topicaine]

RxCUI
1651001
RxNorm name
lidocaine 0.04 MG/MG Topical Gel [Topicaine]
Display name
TOPICAINE (Topical)
Full name
lidocaine 0.04 MG/MG Topical Gel [Topicaine]
Term type
SBD
Status
Active
Strength
4%
Dose form
Gel
Route
Topical
Updated
2026-10-17 23:58:16

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072015
Active start
072015
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride0.04 MG / 1 MGlidocainelidocaine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRTopicaine 4 % Topical Gel1NAMES
RxNorm Namelidocaine 0.04 MG/MG Topical Gel [Topicaine]1NAMES
RxNorm SynonymTopicaine 4 % Topical Gel1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID7f96e980-891e-743d-e053-2a91aa0aea5f1CODES
RxCUI16510011CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63135-312-0463135-312TOPICAINE LIDOCAINE 4%ESBA LABORATORIES INC.M017
63135-312-1363135-312TOPICAINE LIDOCAINE 4%ESBA LABORATORIES INC.M017
63135-312-3063135-312TOPICAINE LIDOCAINE 4%ESBA LABORATORIES INC.M017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01763135-312TOPICAINE LIDOCAINE 4%OTC MONOGRAPH DRUGESBA LABORATORIES INC.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
63135031204rxnav_ndcsyes
63135031213rxnav_ndcsyes
63135031230rxnav_ndcsyes

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
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
ndc (package): 63135-312-30
ndc (package): 63135-312-04
ndc (package): 63135-312-13
ndc (product): 63135-312
ndc11 (package): 63135031213
ndc11 (package): 63135031204
ndc11 (package): 63135031230
rxcui: 1651001

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
7f96e980-891e-743d-e053-2a91aa0aea5fTopicaine 4 % Topical Gel [PSN] · lidocaine 0.04 MG/MG Topical Gel [Topicaine] [SBD] · Topicaine 4 % Topical Gel [SY]35TOPICAINE20260108

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
7f96e980-891e-743d-e053-2a91aa0aea5fTOPICAINEESBA LABORATORIES INC.20260108
7f96e980-891e-743d-e053-2a91aa0aea5fTOPICAINEESBA LABORATORIES INC.20240919

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
ATCC05ADLocal anestheticsATC1-4lidocaine
ATCS01HALocal anestheticsATC1-4lidocaine
FDASPLN0000175682Amide Local AnestheticEPChas_epclidocaine
FDASPLN0000175426AntiarrhythmicEPChas_epclidocaine
FDASPLN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.04 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymTopicaine 4 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK