CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate Oral Rinse USP, 0.12%
Approved
Approval ID
d3c2d8a7-bad5-410f-af83-e78a45e4b93f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
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 Code0121-0893
Application NumberANDA074522
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORHEXIDINE GLUCONATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (7)
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
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