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Lidexa drug information

LIDEXA
Oncora Pharma, LLC · TOPICAL

Product NDC: 85477-330

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameLIDEXA
Labeler / manufacturerOncora Pharma, LLC
RouteTOPICAL
Drug classAmide Local Anesthetic / Antiarrhythmic
Product NDC85477-330
Label effective date2026-02-27

Official product label reference

Lidexa — Oncora Pharma, LLC

This page contains 14 source sections for LIDEXA, topical route. Label set 46d6b3b8-3a9a-44c2-b807-a32f24945f4a, version 1.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

INDICATIONS AND USAGE Lidexa™ is indicated for topical analgesia as directed by a healthcare provider.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION For topical use only. Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.
Contraindications
CONTRAINDICATIONS Lidexa™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation.
Warnings
WARNINGS 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.
Adverse reactions
ADVERSE REACTIONS Localized skin reactions such as redness, irritation, or rash may occur.
Drug interactions
Drug Interactions
Product description
DESCRIPTION Lidexa™ (Lidocaine Hydrochloride) Cream 38.8
Precautions
PRECAUTIONS Use only as directed. If irritation occurs, discontinue use and consult a healthcare provider. General Drug Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Nursing Mothers Pediatric Use
General precautions
General
Carcinogenesis and mutagenesis and impairment of fertility
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Pregnancy
Breastfeeding
Nursing Mothers
Children and adolescents
Pediatric Use
Supply and packaging
HOW SUPPLIED 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

Official sources and product identifiers

Substances listed: LIDOCAINE

RxNorm identifiers: 1723991

Package NDC codes

85477-330-07

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.