pre fense unscented

Generic: benzalkonium chloride

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

Drug Facts

Product Profile

Brand Name pre fense unscented
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 48404-050
Product ID 48404-050_4428ab74-189c-d384-e063-6294a90ad56b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2020-05-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 48404050
Hyphenated Format 48404-050

Supplemental Identifiers

RxCUI
1052949
UPC
0812551020006
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 unscented (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 (48404-050-01)
  • 236.6 mL in 1 BOTTLE (48404-050-02)
  • 502.8 mL in 1 BOTTLE (48404-050-03)
  • 3 BOTTLE in 1 PACKAGE (48404-050-04) / 236.6 mL in 1 BOTTLE
  • 6 BOTTLE in 1 PACKAGE (48404-050-05) / 44.4 mL in 1 BOTTLE
source: ndc

Packages (5)

48404-050-01 44.4 mL in 1 BOTTLE (48404-050-01) 48404-050-02 236.6 mL in 1 BOTTLE (48404-050-02) 48404-050-03 502.8 mL in 1 BOTTLE (48404-050-03) 48404-050-04 3 BOTTLE in 1 PACKAGE (48404-050-04) / 236.6 mL in 1 BOTTLE 48404-050-05 6 BOTTLE in 1 PACKAGE (48404-050-05) / 44.4 mL in 1 BOTTLE

Ingredients (1)

benzalkonium chloride (120 mg/100mL)

Linked Drug Pages (1)

pre fense unscented ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4428ab74-189c-d384-e063-6294a90ad56b", "openfda": {"upc": ["0812551020006"], "unii": ["F5UM2KM3W7"], "rxcui": ["1052949"], "spl_set_id": ["a59e9bbf-b60e-970a-e053-2a95a90aaa5e"], "manufacturer_name": ["Prefense LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "44.4 mL in 1 BOTTLE (48404-050-01)", "package_ndc": "48404-050-01", "marketing_start_date": "20200515"}, {"sample": false, "description": "236.6 mL in 1 BOTTLE (48404-050-02)", "package_ndc": "48404-050-02", "marketing_start_date": "20200515"}, {"sample": false, "description": "502.8 mL in 1 BOTTLE (48404-050-03)", "package_ndc": "48404-050-03", "marketing_start_date": "20200515"}, {"sample": false, "description": "3 BOTTLE in 1 PACKAGE (48404-050-04)  / 236.6 mL in 1 BOTTLE", "package_ndc": "48404-050-04", "marketing_start_date": "20200515"}, {"sample": false, "description": "6 BOTTLE in 1 PACKAGE (48404-050-05)  / 44.4 mL in 1 BOTTLE", "package_ndc": "48404-050-05", "marketing_start_date": "20200515"}], "brand_name": "pre fense unscented", "product_id": "48404-050_4428ab74-189c-d384-e063-6294a90ad56b", "dosage_form": "LIQUID", "product_ndc": "48404-050", "generic_name": "BENZALKONIUM CHLORIDE", "labeler_name": "Prefense LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "pre fense unscented", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "120 mg/100mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200515", "listing_expiration_date": "20261231"}