FDA.reportPublic FDA data

lidocaine hydrochloride 0.03 MG/MG Topical Gel

RxCUI
1372891
RxNorm name
lidocaine hydrochloride 0.03 MG/MG Topical Gel
Display name
Lidocaine (Topical)
Full name
lidocaine hydrochloride 0.03 MG/MG Topical Gel
Term type
SCD
Status
Active
Strength
3%
Dose form
Gel
Route
Topical
Updated
2026-07-27 06:56:53

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042013
Active start
042013
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride0.03 MG / 1 MGlidocainelidocaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRlidocaine hydrochloride 0.03 MG/MG Topical GelNAMES
RxNorm Namelidocaine hydrochloride 0.03 MG/MG Topical GelNAMES
RxNorm Synonymlidocaine hydrochloride 3 % Topical GelNAMES
TTYSCDATTRIBUTES
SPL_SET_ID488ace02-fc0b-4d13-ab89-0e1640e915e5CODES
RxCUI1372891CODES
MMSL_CODEBD28887CODES
MMSL_CODECD28887CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
73698-281-0073698-281SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDEScleraCare, LLCM017
73698-281-0173698-281SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDEScleraCare, LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01773698-281SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDEOTC MONOGRAPH DRUGScleraCare, LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
35356093610rxnav_ndcsyes
35356093630rxnav_ndcsyes
35781030001rxnav_ndcsyes
35781030003rxnav_ndcsyes
35781030009rxnav_ndcsyes
50436133401rxnav_ndcsyes
60760040801rxnav_ndcsyes
60760040830rxnav_ndcsyes
60760040890rxnav_ndcsyes
73698028100rxnav_ndcsyes
73698028101rxnav_ndcsyes
35356093690rxnav_historical
35781030100rxnav_historical
35781030101rxnav_historical
35781030105rxnav_historical
42254043030rxnav_historical
49430005001rxnav_historical
49430005002rxnav_historical
49430005030rxnav_historical
50090135200rxnav_historical
53217006401rxnav_historical
54569641100rxnav_historical
60760040810rxnav_historical
63187012630rxnav_historical
73698010606rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
909baba8-9656-4769-97cf-b642982c3c9flidocaine hydrochloride 0.03 MG/MG Topical GelSCD11LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval20221004
909baba8-9656-4769-97cf-b642982c3c9flidocaine HCl 3 % Topical GelPSN11LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval20221004
909baba8-9656-4769-97cf-b642982c3c9flidocaine hydrochloride 3 % Topical GelSY11LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval20221004
488ace02-fc0b-4d13-ab89-0e1640e915e5lidocaine hydrochloride 0.03 MG/MG Topical GelSCD2SCLERA CARE Topical Anesthetic Gel20231105
488ace02-fc0b-4d13-ab89-0e1640e915e5lidocaine HCl 3 % Topical GelPSN2SCLERA CARE Topical Anesthetic Gel20231105
488ace02-fc0b-4d13-ab89-0e1640e915e5lidocaine hydrochloride 3 % Topical GelSY2SCLERA CARE Topical Anesthetic Gel20231105
95ae61d8-d9a2-4e50-9065-c0cb97b95743lidocaine hydrochloride 0.03 MG/MG Topical GelSCD1LidoRx (Lidocaine HCl USP) 3%20140109
95ae61d8-d9a2-4e50-9065-c0cb97b95743lidocaine hydrochloride 3 % Topical GelSY1LidoRx (Lidocaine HCl USP) 3%20140109
95ae61d8-d9a2-4e50-9065-c0cb97b95743lidocaine HCl 3 % Topical GelPSN1LidoRx (Lidocaine HCl USP) 3%20140109

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
488ace02-fc0b-4d13-ab89-0e1640e915e5SCLERA CARE Topical Anesthetic GelScleraCare, LLC20231105
909baba8-9656-4769-97cf-b642982c3c9fLiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. ApprovalGensco Laboratories, LLC20221004
0b3e8433-4f93-4f01-9df0-020fb6922bceLidoDose Topical AnestheticGensco Laboratories, LLC20221004
95ae61d8-d9a2-4e50-9065-c0cb97b95743LidoRx (Lidocaine HCl USP) 3%Aidarex Pharmaceuticals LLC20140109

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_STRENGTH0.03 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD28887
CODESMMSL_CODECD28887
CODESRxCUI1372891
CODESSPL_SET_ID488ace02-fc0b-4d13-ab89-0e1640e915e5
CODESVUID4032281
NAMESPrescribable Synonymlidocaine HCl 3 % Topical Gel
NAMESRXNAV_STRlidocaine hydrochloride 0.03 MG/MG Topical Gel
NAMESRxNorm Namelidocaine hydrochloride 0.03 MG/MG Topical Gel
NAMESRxNorm Synonymlidocaine hydrochloride 3 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File