antibacterial hand cleanser

Generic: benzalkonium chloride

Labeler: kutol products company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antibacterial hand cleanser
Generic Name benzalkonium chloride
Labeler kutol products company
Dosage Form SOAP
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .013 mg/mL

Manufacturer
Kutol Products Company

Identifiers & Regulatory

Product NDC 50865-215
Product ID 50865-215_03fbe342-a3b7-9a63-e063-6294a90a15f2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2017-08-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50865215
Hyphenated Format 50865-215

Supplemental Identifiers

UPC
0686702050095
UNII
F5UM2KM3W7

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 antibacterial hand cleanser (source: ndc)
Generic Name benzalkonium chloride (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .013 mg/mL
source: ndc
Packaging
  • 3785 mL in 1 BOTTLE, PLASTIC (50865-215-09)
  • 1200 mL in 1 BAG (50865-215-12)
  • 237 mL in 1 BOTTLE, PUMP (50865-215-19)
  • 800 mL in 1 BAG (50865-215-65)
source: ndc

Packages (4)

50865-215-09 3785 mL in 1 BOTTLE, PLASTIC (50865-215-09) 50865-215-12 1200 mL in 1 BAG (50865-215-12) 50865-215-19 237 mL in 1 BOTTLE, PUMP (50865-215-19) 50865-215-65 800 mL in 1 BAG (50865-215-65)

Ingredients (1)

benzalkonium chloride (.013 mg/mL)

Linked Drug Pages (1)

Antibacterial Hand Cleanser ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "03fbe342-a3b7-9a63-e063-6294a90a15f2", "openfda": {"upc": ["0686702050095"], "unii": ["F5UM2KM3W7"], "spl_set_id": ["56f50eda-5399-1bfe-e054-00144ff8d46c"], "manufacturer_name": ["Kutol Products Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3785 mL in 1 BOTTLE, PLASTIC (50865-215-09)", "package_ndc": "50865-215-09", "marketing_start_date": "20170817"}, {"sample": false, "description": "1200 mL in 1 BAG (50865-215-12)", "package_ndc": "50865-215-12", "marketing_start_date": "20170817"}, {"sample": false, "description": "237 mL in 1 BOTTLE, PUMP (50865-215-19)", "package_ndc": "50865-215-19", "marketing_start_date": "20170817"}, {"sample": false, "description": "800 mL in 1 BAG (50865-215-65)", "package_ndc": "50865-215-65", "marketing_start_date": "20170817"}], "brand_name": "Antibacterial Hand Cleanser", "product_id": "50865-215_03fbe342-a3b7-9a63-e063-6294a90a15f2", "dosage_form": "SOAP", "product_ndc": "50865-215", "generic_name": "Benzalkonium chloride", "labeler_name": "Kutol Products Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antibacterial Hand Cleanser", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".013 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170817", "listing_expiration_date": "20261231"}