FDA.reportPublic FDA data

Lidexa

Manufacturer
Oncora Pharma, LLC
Effective date
2026-02-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:07:37

Label at a glance#

ProductLidexa
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

Lidexa™ is indicated for topical analgesia as directed by a healthcare provider.

Dosage and administration

For topical use only. Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Lidexa™ (Lidocaine Hydrochloride) Cream 38.8

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Lidexa™ is indicated for topical analgesia as directed by a healthcare provider.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Lidexa™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation.

WARNINGS

WARNINGS SECTION

For external use only. Not for ophthalmic use.

Avoid contact with eyes.

Excessive application may result in increased systemic absorption.

Keep out of reach of children.

PRECAUTIONS

PRECAUTIONS SECTION

Use only as directed. If irritation occurs, discontinue use and consult a healthcare provider.

General

GENERAL PRECAUTIONS SECTION

Drug Interactions

DRUG INTERACTIONS SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Pregnancy

PREGNANCY SECTION

Nursing Mothers

NURSING MOTHERS SECTION

Pediatric Use

PEDIATRIC USE SECTION

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Localized skin reactions such as redness, irritation, or rash may occur.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For topical use only.

Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.

HOW SUPPLIED

HOW SUPPLIED SECTION

Lidexa™ (Lidocaine Hydrochloride 38.8 mg/g) is supplied as a white topical cream in a 3 oz (85 g) tube.

NDC 85477-330-07

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp
pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1723991lidocaine HCl 3.88 % Topical CreamPSN1
1723991lidocaine hydrochloride 38.8 MG/ML Topical CreamSCD1
1723991lidocaine hydrochloride 3.88 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770330078GTIN-13: 0854770330078
EAN-13: 0854770330078
GTIN-12: 854770330078
UPC-A: 854770330078
GTIN storage (14 digits): 00854770330078		lidexa-1.jpg

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
85477-330-07Lidexa85 g in 1 BOTTLE, PUMPCREAM851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-330-07GM - Gram85477-330012decf9-a544-484e-9f6a-772a0033198512026-04-20

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-33085477-330-07

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB

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
LidexaLIDEXAOncora Pharma, LLC46d6b3b8-3a9a-44c2-b807-a32f24945f4a2026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 85477-330-07
ndc (product): 85477-330
ndc11 (package): 85477033007
spl id: cb6c85bc-f245-431d-8ded-4a4d8c83dbb2
spl set id: 46d6b3b8-3a9a-44c2-b807-a32f24945f4a

Reported adverse events (FAERS/openFDA)#

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