Chlorhexidine Gluconate
CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%
Approved
Approval ID
43a8c4e8-3679-485d-88fc-8bccdba7de1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorhexidine Gluconate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-524
Application NumberANDA074356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (8)
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT