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FDA Approval

Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Bajaj Medical, LLC
DUNS: 078774921
Effective Date
January 2, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chlorhexidine(1.2 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bajaj Medical, LLC

078774921

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Bajaj Medical, LLC

Bajaj Medical, LLC

Bajaj Medical, LLC

078774921

Products1

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

Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

Product Details

NDC Product Code
61037-469
Application Number
ANDA075561
Marketing Category
ANDA (C73584)
Route of Administration
DENTAL
Effective Date
January 2, 2024
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
Code: MOR84MUD8EClass: ACTIBQuantity: 1.2 mg in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1GClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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