Lidocaine Hydrochloride
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (Viscous)
Approved
Approval ID
cc1cd1ff-b219-4281-8378-118f4f1beee3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2021
Manufacturers
FDA
PINNACLE PHARMA LLC
DUNS: 081126970
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 Code81646-143
Application NumberANDA040708
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationOROPHARYNGEAL
Effective DateJanuary 28, 2022
FDA Product Classification
INGREDIENTS (8)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB