FDA.reportPublic FDA data

lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]

RxCUI
1939340
RxNorm name
lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]
Display name
LIDOZEN (Topical)
Full name
lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]
Term type
SBD
Status
Active
Strength
4-1%
Dose form
Gel
Route
Topical
Updated
2026-10-30 15:31:35

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092017
Active start
092017
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride0.04 MG / 1 MGlidocainelidocaine hydrochloride
menthol0.01 MG / 1 MGmentholmenthol

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387
menthol6750

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRLidozen 4 % / 1 % Topical Gel1NAMES
RxNorm Namelidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI19393401CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63187-892-7263187-892Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LPM017
71205-715-7271205-715Lidozen Gel LIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LPM017
71574-300-7271574-300Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLCM017
71574-305-7271574-305Lidozen Gel LIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01763187-892Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOLOTC MONOGRAPH DRUGProficient Rx LP

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
63187089264rxnav_ndcsyes
63187089272rxnav_ndcsyes
71205071572rxnav_ndcsyes
71574030072rxnav_ndcsyes
71574030572rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCffb7831f-4ca9-4d73-8303-e9cd900789822026-01-01WarningsExact identifier
ndc (package): 71574-305-72
ndc (product): 71574-305
ndc11 (package): 71574030572
rxcui: 1939340
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP7c300dec-cefd-4b79-a948-a917b7708a042023-12-01WarningsExact identifier
ndc (package): 71205-715-72
ndc (product): 71205-715
ndc11 (package): 71205071572
rxcui: 1939340
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
ndc (package): 71574-300-72
ndc (product): 71574-300
ndc11 (package): 71574030072
rxcui: 1939340
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP1ebb45e5-4541-4c95-abe1-661ef763a6102023-11-01WarningsExact identifier
ndc (package): 63187-892-72
ndc (product): 63187-892
ndc11 (package): 63187089272
ndc11 (package): 63187089264
rxcui: 1939340

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
1ebb45e5-4541-4c95-abe1-661ef763a610LidozenGel 4 % / 1 % Topical Gel [PSN] · lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen] [SBD] · Lidozen 4 % / 1 % Topical Gel [SY] · LidozenGel 4 % / 1 % Topical Gel [SY]48Lidozen Gel20231101
ffb7831f-4ca9-4d73-8303-e9cd90078982LidozenGel 4 % / 1 % Topical Gel [PSN] · lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen] [SBD] · Lidozen 4 % / 1 % Topical Gel [SY] · LidozenGel 4 % / 1 % Topical Gel [SY]43Lidozen Gel20260101
55108ffd-d6a8-41de-e054-00144ff88e88LidozenGel 4 % / 1 % Topical Gel [PSN] · lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen] [SBD] · Lidozen 4 % / 1 % Topical Gel [SY] · LidozenGel 4 % / 1 % Topical Gel [SY]43Lidozen Gel20231111
7c300dec-cefd-4b79-a948-a917b7708a04LidozenGel 4 % / 1 % Topical Gel [PSN] · lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen] [SBD] · Lidozen 4 % / 1 % Topical Gel [SY] · LidozenGel 4 % / 1 % Topical Gel [SY]42Lidozen Gel20231201

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ffb7831f-4ca9-4d73-8303-e9cd90078982Lidozen GelVillage Pharma LLC20260101
7c300dec-cefd-4b79-a948-a917b7708a04Lidozen GelProficient Rx LP20231201
55108ffd-d6a8-41de-e054-00144ff88e88Lidozen GelVillage Pharma, LLC20231111
1ebb45e5-4541-4c95-abe1-661ef763a610Lidozen GelProficient Rx LP20231101

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 hydrochloride
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD008610MentholCHEMhas_ingredientmenthol
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine hydrochloride
MEDRTD002056BurnsDISEASEmay_treatlidocaine hydrochloride
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withmenthol
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD006967HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD009203Myocardial InfarctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_preventlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_treatmenthol
MEDRTD012871Skin DiseasesDISEASEmay_treatmenthol
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
MEDRTN0000000069Calcium Channel AntagonistsMOAhas_moamenthol
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 hydrochloride
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pementhol
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.04 MG/MG (expressed as lidocaine hydrochloride) / 0.01 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymLidozenGel 4 % / 1 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK