chlorhexidine gluconate, 0.12% oral rinse solution

Generic: chlorhexidine gluconate, 0.12% oral rinse solution

Labeler: bajaj medical, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorhexidine gluconate, 0.12% oral rinse solution
Generic Name chlorhexidine gluconate, 0.12% oral rinse solution
Labeler bajaj medical, llc
Dosage Form SOLUTION
Routes
DENTAL
Active Ingredients

chlorhexidine gluconate 1.2 mg/mL

Manufacturer
Bajaj Medical, LLC

Identifiers & Regulatory

Product NDC 61037-469
Product ID 61037-469_0dfd551e-3e6f-769f-e063-6294a90ad610
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075561
Listing Expiration 2026-12-31
Marketing Start 2021-11-17

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61037469
Hyphenated Format 61037-469

Supplemental Identifiers

RxCUI
834127
UPC
0361037469025 0361037469032
UNII
MOR84MUD8E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name chlorhexidine gluconate, 0.12% oral rinse solution (source: ndc)
Generic Name chlorhexidine gluconate, 0.12% oral rinse solution (source: ndc)
Application Number ANDA075561 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1.2 mg/mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (61037-469-02)
  • 473 mL in 1 BOTTLE (61037-469-03)
  • 1893 mL in 1 JUG (61037-469-05)
  • 15 mL in 1 CUP, UNIT-DOSE (61037-469-07)
source: ndc

Packages (4)

61037-469-02 118 mL in 1 BOTTLE (61037-469-02) 61037-469-03 473 mL in 1 BOTTLE (61037-469-03) 61037-469-05 1893 mL in 1 JUG (61037-469-05) 61037-469-07 15 mL in 1 CUP, UNIT-DOSE (61037-469-07)

Ingredients (1)

chlorhexidine gluconate (1.2 mg/mL)

Linked Drug Pages (1)

Chlorhexidine Gluconate, 0.12% Oral Rinse Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "0dfd551e-3e6f-769f-e063-6294a90ad610", "openfda": {"upc": ["0361037469025", "0361037469032"], "unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["d44f4e79-e684-a1ef-e053-2995a90a4620"], "manufacturer_name": ["Bajaj Medical, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (61037-469-02)", "package_ndc": "61037-469-02", "marketing_start_date": "20211117"}, {"sample": false, "description": "473 mL in 1 BOTTLE (61037-469-03)", "package_ndc": "61037-469-03", "marketing_start_date": "20211117"}, {"sample": false, "description": "1893 mL in 1 JUG (61037-469-05)", "package_ndc": "61037-469-05", "marketing_start_date": "20211117"}, {"sample": false, "description": "15 mL in 1 CUP, UNIT-DOSE (61037-469-07)", "package_ndc": "61037-469-07", "marketing_start_date": "20211117"}], "brand_name": "Chlorhexidine Gluconate, 0.12% Oral Rinse Solution", "product_id": "61037-469_0dfd551e-3e6f-769f-e063-6294a90ad610", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "61037-469", "generic_name": "Chlorhexidine Gluconate, 0.12% Oral Rinse Solution", "labeler_name": "Bajaj Medical, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorhexidine Gluconate, 0.12% Oral Rinse Solution", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "1.2 mg/mL"}], "application_number": "ANDA075561", "marketing_category": "ANDA", "marketing_start_date": "20211117", "listing_expiration_date": "20261231"}