Lidocaine Hydrochloride

Basic Information

Product Name

FDA Product Code

55154-9631

Regulatory Information

NDC Product Code

55154-9631

Application Number

ANDA040014

Marketing Category

C73584

Effective Date

April 27, 2023

Territorial Authority

USA

FDA Title

LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Code: K679OBS311

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

ORANGE

Code: 5EVU04N5QU

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Quantity: 20 mg in 1 mL

Code: EC2CNF7XFP

Class Code: ACTIB

Active Moieties

LIDOCAINE

Code: 98PI200987

Basic Information

Regulatory Information

Company Information

Active Ingredients

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

METHYLPARABEN

PROPYLPARABEN

ORANGE

WATER

SACCHARIN SODIUM

HYDROCHLORIC ACID

SODIUM HYDROXIDE

Active Moieties

LIDOCAINE