FDA.reportPublic FDA data

lidocaine 0.05 MG/MG Rectal Gel [Topicaine]

RxCUI
1652108
RxNorm name
lidocaine 0.05 MG/MG Rectal Gel [Topicaine]
Display name
TOPICAINE (Rectal)
Full name
lidocaine 0.05 MG/MG Rectal Gel [Topicaine]
Term type
SBD
Status
Active
Strength
5%
Dose form
Gel
Route
Rectal
Updated
2026-10-17 23:58:18

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
lidocaine0.05 MG / 1 MGlidocainelidocaine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Rectal Gel346170

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRTopicaine-5 5 % Rectal Gel1NAMES
RxNorm Namelidocaine 0.05 MG/MG Rectal Gel [Topicaine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID15d33ff7-34ed-253d-e054-00144ff88e881CODES
RxCUI16521081CODES
MMSL_CODEBD270641CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63135-581-0463135-581TOPICAINE 5 LIDOCAINE 5%ESBA LABORATORIES INC.M015
63135-581-1063135-581TOPICAINE 5 LIDOCAINE 5%ESBA LABORATORIES INC.M015
63135-581-3063135-581TOPICAINE 5 LIDOCAINE 5%ESBA LABORATORIES INC.M015

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01563135-581TOPICAINE 5 LIDOCAINE 5%OTC MONOGRAPH DRUGESBA LABORATORIES INC.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
63135058104rxnav_ndcsyes
63135058110rxnav_ndcsyes
63135058130rxnav_ndcsyes
63135058113rxnav_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
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
ndc (package): 63135-581-30
ndc (package): 63135-581-04
ndc (package): 63135-581-10
ndc (product): 63135-581
ndc11 (package): 63135058130
ndc11 (package): 63135058104
ndc11 (package): 63135058110
rxcui: 1652108

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
15d33ff7-34ed-253d-e054-00144ff88e88Topicaine-5 5 % Rectal Gel [PSN] · lidocaine 0.05 MG/MG Rectal Gel [Topicaine] [SBD] · Topicaine 0.05 MG/MG Rectal Gel [SY] · Topicaine-5 5 % Rectal Gel [SY]411TOPICAINE 520260108

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
15d33ff7-34ed-253d-e054-00144ff88e88TOPICAINE 5ESBA LABORATORIES INC.20260108
15d33ff7-34ed-253d-e054-00144ff88e88TOPICAINE 5ESBA 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_STRENGTH0.05 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymTopicaine-5 5 % Rectal Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon