pre fense

Generic: benzalkonium chloride

Labeler: prefense llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pre fense
Generic Name benzalkonium chloride
Labeler prefense llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 120 mg/100mL

Manufacturer
Prefense LLC

Identifiers & Regulatory

Product NDC 48404-051
Product ID 48404-051_44278015-2997-7473-e063-6294a90ac3bf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2020-05-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 48404051
Hyphenated Format 48404-051

Supplemental Identifiers

RxCUI
1052949
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 pre fense (source: ndc)
Generic Name benzalkonium chloride (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/100mL
source: ndc
Packaging
  • 44.4 mL in 1 BOTTLE (48404-051-01)
  • 237 mL in 1 BOTTLE (48404-051-02)
  • 1000 mL in 1 POUCH (48404-051-03)
  • 1893 mL in 1 JUG (48404-051-04)
  • 6 BOTTLE in 1 PACKAGE (48404-051-05) / 44.4 mL in 1 BOTTLE
  • 3 BOTTLE in 1 PACKAGE (48404-051-06) / 236.6 mL in 1 BOTTLE
source: ndc

Packages (6)

48404-051-01 44.4 mL in 1 BOTTLE (48404-051-01) 48404-051-02 237 mL in 1 BOTTLE (48404-051-02) 48404-051-03 1000 mL in 1 POUCH (48404-051-03) 48404-051-04 1893 mL in 1 JUG (48404-051-04) 48404-051-05 6 BOTTLE in 1 PACKAGE (48404-051-05) / 44.4 mL in 1 BOTTLE 48404-051-06 3 BOTTLE in 1 PACKAGE (48404-051-06) / 236.6 mL in 1 BOTTLE

Ingredients (1)

benzalkonium chloride (120 mg/100mL)

Linked Drug Pages (1)

pre fense ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "44278015-2997-7473-e063-6294a90ac3bf", "openfda": {"unii": ["F5UM2KM3W7"], "rxcui": ["1052949"], "spl_set_id": ["fad70060-8bb6-4b06-a353-666132f64c26"], "manufacturer_name": ["Prefense LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "44.4 mL in 1 BOTTLE (48404-051-01)", "package_ndc": "48404-051-01", "marketing_start_date": "20200511"}, {"sample": false, "description": "237 mL in 1 BOTTLE (48404-051-02)", "package_ndc": "48404-051-02", "marketing_start_date": "20200511"}, {"sample": false, "description": "1000 mL in 1 POUCH (48404-051-03)", "package_ndc": "48404-051-03", "marketing_start_date": "20200511"}, {"sample": false, "description": "1893 mL in 1 JUG (48404-051-04)", "package_ndc": "48404-051-04", "marketing_start_date": "20200511"}, {"sample": false, "description": "6 BOTTLE in 1 PACKAGE (48404-051-05)  / 44.4 mL in 1 BOTTLE", "package_ndc": "48404-051-05", "marketing_start_date": "20200511"}, {"sample": false, "description": "3 BOTTLE in 1 PACKAGE (48404-051-06)  / 236.6 mL in 1 BOTTLE", "package_ndc": "48404-051-06", "marketing_start_date": "20200511"}], "brand_name": "pre fense", "product_id": "48404-051_44278015-2997-7473-e063-6294a90ac3bf", "dosage_form": "LIQUID", "product_ndc": "48404-051", "generic_name": "BENZALKONIUM CHLORIDE", "labeler_name": "Prefense LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "pre fense", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "120 mg/100mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200511", "listing_expiration_date": "20261231"}