Chlorhexidine
Chlorhexidine Gluconate Oral Rinse, 0.12%
Approved
Approval ID
a6ebff38-0fdf-4cbf-a89a-acd487a253aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 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.
Chlorhexidine Gluconate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81646-102
Application NumberANDA074522
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2021
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT