Oraqix
These highlights do not include all the information needed to use ORAQIX safely and effectively. See full prescribing information for ORAQIX. ORAQIX (lidocaine and prilocaine periodontal gel) 2.5%/2.5% Initial U.S. Approval: 2003
Approved
Approval ID
b501d239-923b-48b2-82ed-6c5c253a67e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2024
Manufacturers
FDA
Dentsply Pharmaceutical
DUNS: 102221942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lidocaine and prilocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66312-110
Application NumberNDA021451
Product Classification
M
Marketing Category
C73594
G
Generic Name
lidocaine and prilocaine
Product Specifications
Route of AdministrationPERIODONTAL
Effective DateJanuary 26, 2024
FDA Product Classification
INGREDIENTS (6)
LIDOCAINEActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
PRILOCAINEActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT