guardelle

Generic: benzalkonium chloride

Labeler: social medical supply llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guardelle
Generic Name benzalkonium chloride
Labeler social medical supply llc
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .13 g/100mL

Manufacturer
Social Medical Supply LLC

Identifiers & Regulatory

Product NDC 85754-000
Product ID 85754-000_3a8774ed-4fdf-48b6-a54b-8db85492cb34
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2025-10-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85754000
Hyphenated Format 85754-000

Supplemental Identifiers

RxCUI
1020365
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 guardelle (source: ndc)
Generic Name benzalkonium chloride (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .13 g/100mL
source: ndc
Packaging
  • 52 mL in 1 BOTTLE, PUMP (85754-000-02)
  • 207 mL in 1 BOTTLE, PUMP (85754-000-07)
  • 500 mL in 1 BOTTLE, PUMP (85754-000-18)
source: ndc

Packages (3)

Ingredients (1)

benzalkonium chloride (.13 g/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "3a8774ed-4fdf-48b6-a54b-8db85492cb34", "openfda": {"unii": ["F5UM2KM3W7"], "rxcui": ["1020365"], "spl_set_id": ["8793e3be-7409-4f71-9397-abbeacd27cf8"], "manufacturer_name": ["Social Medical Supply LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "52 mL in 1 BOTTLE, PUMP (85754-000-02)", "package_ndc": "85754-000-02", "marketing_start_date": "20251016"}, {"sample": false, "description": "207 mL in 1 BOTTLE, PUMP (85754-000-07)", "package_ndc": "85754-000-07", "marketing_start_date": "20251016"}, {"sample": false, "description": "500 mL in 1 BOTTLE, PUMP (85754-000-18)", "package_ndc": "85754-000-18", "marketing_start_date": "20251016"}], "brand_name": "Guardelle", "product_id": "85754-000_3a8774ed-4fdf-48b6-a54b-8db85492cb34", "dosage_form": "AEROSOL, FOAM", "product_ndc": "85754-000", "generic_name": "BENZALKONIUM CHLORIDE", "labeler_name": "Social Medical Supply LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guardelle", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".13 g/100mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251016", "listing_expiration_date": "20261231"}