FDA.reportPublic FDA data

Lidozen Gel

Manufacturer
Village Pharma, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:00:06

Label at a glance#

ProductLidozen
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure6 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Apply directly to affected area. Do not use more than four times per day.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.00%

Menthol 1.00%

OTC - PURPOSE SECTION

Topical Anesthetic

External Analgesic

USES:

INDICATIONS & USAGE SECTION

For temporary relief of pain

WARNINGS:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • ​ ask a health professional before use. ​If pregnant or breast-feeding,

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS (Adults and Children Over 12 Years):

DOSAGE & ADMINISTRATION SECTION

Apply directly to affected area. Do not use more than four times per day.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN3
1939340LidozenGel 4 % / 1 % Topical GelPSN3
1939340lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]SBD3
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD3
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY3
1939340Lidozen 4 % / 1 % Topical GelSY3
1939340LidozenGel 4 % / 1 % Topical GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71574-300-72Lidozen120 mL in 1 BOTTLEGEL1203
71574-300-72Lidozen1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-300LIDOZEN (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [VILLAGE PHARMA, LLC]3Current NDC, Legacy NDC, 2 package rows20231112_55108ffd-d6a8-41de-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-300-72ML - Milliliter71574-300222376ab-79df-474b-b2c7-7a9e9f567ca712017-10-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71574-30071574-300-72

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
ndc (package): 71574-300-72
ndc (product): 71574-300
ndc11 (package): 71574030072
spl id: 09db59ea-79d1-56ef-e063-6294a90a0c4b
spl set id: 55108ffd-d6a8-41de-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.