chlorhexidine gluconate 0.12% oral rinse

Generic: chlorhexidine gluconate

Labeler: xttrium laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorhexidine gluconate 0.12% oral rinse
Generic Name chlorhexidine gluconate
Labeler xttrium laboratories, inc.
Dosage Form LIQUID
Routes
BUCCAL
Active Ingredients

chlorhexidine gluconate 1.2 [iU]/mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-0003
Product ID 0116-0003_a187f677-2f93-8f95-e053-2a95a90a4c59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077789
Listing Expiration 2026-12-31
Marketing Start 2014-01-20

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01160003
Hyphenated Format 0116-0003

Supplemental Identifiers

RxCUI
834127
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 (source: ndc)
Generic Name chlorhexidine gluconate (source: ndc)
Application Number ANDA077789 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 1.2 [iU]/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (0116-0003-15)
source: ndc

Packages (1)

0116-0003-15 15 mL in 1 BOTTLE (0116-0003-15)

Ingredients (1)

chlorhexidine gluconate (1.2 [iU]/mL)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "a187f677-2f93-8f95-e053-2a95a90a4c59", "openfda": {"unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["4a3a4cfe-88e2-0a10-e054-00144ff88e88"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (0116-0003-15)", "package_ndc": "0116-0003-15", "marketing_start_date": "20140120"}], "brand_name": "Chlorhexidine Gluconate 0.12% Oral Rinse", "product_id": "0116-0003_a187f677-2f93-8f95-e053-2a95a90a4c59", "dosage_form": "LIQUID", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-0003", "generic_name": "CHLORHEXIDINE GLUCONATE", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorhexidine Gluconate 0.12% Oral Rinse", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "1.2 [iU]/mL"}], "application_number": "ANDA077789", "marketing_category": "ANDA", "marketing_start_date": "20140120", "listing_expiration_date": "20261231"}