Lidocaine Viscous
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)
Approved
Approval ID
efb8bc14-26e8-4451-a40d-60bdfe4c605c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2022
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0903
Application NumberANDA088802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (6)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR