MedPath

Chlorhexidine Gluconate Oral Rinse

Chlorhexidine Gluconate Oral Rinse, USP 0.12%Rising Pharma Holdings, Inc.

Approved
Approval ID

b6b45b87-aa53-4d3a-be59-f3d3b0774a7b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 22, 2023

Manufacturers
FDA

Rising Pharma Holdings, Inc.

DUNS: 116880195

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorhexidine Gluconate Oral Rinse

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16571-128
Application NumberANDA075561
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate Oral Rinse
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 28, 2023
FDA Product Classification

INGREDIENTS (7)

CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Chlorhexidine Gluconate Oral Rinse - FDA Drug Approval Details