Lidocaine
FOR EXTERNAL USE ONLY DO NOT USE IN THE EYES Rx Only
Approved
Approval ID
abf864dd-e75f-4a02-8caf-3ad816cd540b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2022
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-0473
Application NumberANDA207810
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 26, 2018
FDA Product Classification
INGREDIENTS (3)
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT