MedPath

Lidocaine

LIDOCAINE OINTMENT USP, 5%

Approved
Approval ID

6b9ba38c-7df4-4e95-814e-c58d99ccae17

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2019

Manufacturers
FDA

Lake Erie Medical DBA Quality Care Products LLC

DUNS: 831276758

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 Code55700-384
Application NumberANDA040911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 23, 2016
FDA Product Classification

INGREDIENTS (4)

LIDOCAINEActive
Quantity: 5 g in 100 g
Code: 98PI200987
Classification: ACTIB
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Lidocaine - FDA Drug Approval Details