Chlorhexidine Gluconate
pro-den Rx oral rinse USP 0.12% chlorhexidine gluconate
Approved
Approval ID
a2d2d555-89a5-42d7-81d5-50fd7e741f83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2023
Manufacturers
FDA
Den-mat Holdings, Llc
DUNS: 809857704
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 Code59883-175
Application NumberANDA077789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2019
FDA Product Classification
INGREDIENTS (7)
Chlorhexidine GluconateActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 Sorbitan DiisostearateInactive
Code: JL4CCU7I1G
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT