chlorhexidine gluconate 0.12% oral rinse (53462-003)

Drug Facts

Product Profile

Brand Name chlorhexidine gluconate 0.12% oral rinse

Generic Name chlorhexidine gluconate

Labeler sage products llc

Dosage Form LIQUID

Routes

BUCCAL

Active Ingredients

chlorhexidine gluconate 1.2 mg/mL

Manufacturer

Sage Products LLC

Identifiers & Regulatory

Product NDC 53462-003

Product ID 53462-003_41ae4422-c96e-9918-e063-6394a90ad0a3

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 53462003

Hyphenated Format 53462-003

Supplemental Identifiers

RxCUI

834127

UPC

0353462003158

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 mg/mL

source: ndc

Packaging

15 mL in 1 BOTTLE (53462-003-15)

source: ndc

Packages (1)

53462-003-15 15 mL in 1 BOTTLE (53462-003-15)

Ingredients (1)

chlorhexidine gluconate (1.2 mg/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": "41ae4422-c96e-9918-e063-6394a90ad0a3", "openfda": {"upc": ["0353462003158"], "unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["3c754532-d9a5-f876-00c4-05a4c9b21efa"], "manufacturer_name": ["Sage Products LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (53462-003-15)", "package_ndc": "53462-003-15", "marketing_start_date": "20140120"}], "brand_name": "Chlorhexidine Gluconate 0.12% Oral Rinse", "product_id": "53462-003_41ae4422-c96e-9918-e063-6394a90ad0a3", "dosage_form": "LIQUID", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "53462-003", "generic_name": "CHLORHEXIDINE GLUCONATE", "labeler_name": "Sage Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorhexidine Gluconate 0.12% Oral Rinse", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "1.2 mg/mL"}], "application_number": "ANDA077789", "marketing_category": "ANDA", "marketing_start_date": "20140120", "listing_expiration_date": "20261231"}