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Lidocaine

LIDOCAINE OINTMENT USP, 5%

Approved
Approval ID

c18f0c2b-cd05-4458-888f-47b4a1106937

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 3, 2020

Manufacturers
FDA

Asclemed USA, Inc.

DUNS: 059888437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76420-131
Application NumberANDA205318
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 3, 2020
FDA Product Classification

INGREDIENTS (3)

POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB

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Lidocaine - FDA Drug Approval Details