antibacterial

Generic: benzalkonium chloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antibacterial
Generic Name benzalkonium chloride
Labeler topco associates llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 1.3 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-279
Product ID 76162-279_4a014918-5eb6-c2ee-e063-6394a90ae746
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 2025-12-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162279
Hyphenated Format 76162-279

Supplemental Identifiers

RxCUI
1046593
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 (source: ndc)
Generic Name benzalkonium chloride (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.3 mg/mL
source: ndc
Packaging
  • 1478 mL in 1 BOTTLE, PLASTIC (76162-279-03)
  • 221 mL in 1 BOTTLE, PLASTIC (76162-279-96)
source: ndc

Packages (2)

76162-279-03 1478 mL in 1 BOTTLE, PLASTIC (76162-279-03) 76162-279-96 221 mL in 1 BOTTLE, PLASTIC (76162-279-96)

Ingredients (1)

benzalkonium chloride (1.3 mg/mL)

Linked Drug Pages (1)

ANTIBACTERIAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4a014918-5eb6-c2ee-e063-6394a90ae746", "openfda": {"unii": ["F5UM2KM3W7"], "rxcui": ["1046593"], "spl_set_id": ["463f3a53-921a-65cb-e063-6394a90ab4f2"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1478 mL in 1 BOTTLE, PLASTIC (76162-279-03)", "package_ndc": "76162-279-03", "marketing_start_date": "20251218"}, {"sample": false, "description": "221 mL in 1 BOTTLE, PLASTIC (76162-279-96)", "package_ndc": "76162-279-96", "marketing_start_date": "20251218"}], "brand_name": "ANTIBACTERIAL", "product_id": "76162-279_4a014918-5eb6-c2ee-e063-6394a90ae746", "dosage_form": "LIQUID", "product_ndc": "76162-279", "generic_name": "benzalkonium chloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ANTIBACTERIAL", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "1.3 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251218", "listing_expiration_date": "20271231"}