lidocaine
Lidocaine Ointment, 5% for topical use DO NOT USE IN THE EYES Rx Only
Approved
Approval ID
1361b4e3-bcbb-4dec-8aaa-b06bb2c3c0a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
FORREAL PHARMACEUTICALS LLC
DUNS: 118029197
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 Code81877-519
Application NumberANDA206498
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (3)
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT