durashield

Generic: benzalkonium chloride

Labeler: advanced biomedical incorporated
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name durashield
Generic Name benzalkonium chloride
Labeler advanced biomedical incorporated
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .13 mg/mL

Manufacturer
Advanced Biomedical Incorporated

Identifiers & Regulatory

Product NDC 85131-013
Product ID 85131-013_b9f737e2-25dc-44cc-aa07-a5a77758473c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2024-12-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85131013
Hyphenated Format 85131-013

Supplemental Identifiers

UPC
0850027212098 0850027212135 0850027212142 0850027212104 0850027212111 0850027212128
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 durashield (source: ndc)
Generic Name benzalkonium chloride (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .13 mg/mL
source: ndc
Packaging
  • .33 mL in 1 BOTTLE (85131-013-00)
  • 60 mL in 1 BOTTLE (85131-013-02)
  • 118 mL in 1 BOTTLE (85131-013-04)
  • 237 mL in 1 BOTTLE, PUMP (85131-013-08)
  • 355 mL in 1 BOTTLE, PUMP (85131-013-12)
  • 473 mL in 1 BOTTLE, PUMP (85131-013-16)
source: ndc

Packages (6)

85131-013-00 .33 mL in 1 BOTTLE (85131-013-00) 85131-013-02 60 mL in 1 BOTTLE (85131-013-02) 85131-013-04 118 mL in 1 BOTTLE (85131-013-04) 85131-013-08 237 mL in 1 BOTTLE, PUMP (85131-013-08) 85131-013-12 355 mL in 1 BOTTLE, PUMP (85131-013-12) 85131-013-16 473 mL in 1 BOTTLE, PUMP (85131-013-16)

Ingredients (1)

benzalkonium chloride (.13 mg/mL)

Linked Drug Pages (1)

Durashield ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "b9f737e2-25dc-44cc-aa07-a5a77758473c", "openfda": {"upc": ["0850027212098", "0850027212135", "0850027212142", "0850027212104", "0850027212111", "0850027212128"], "unii": ["F5UM2KM3W7"], "spl_set_id": ["b0723781-225a-46c6-907c-5c5c48f383b8"], "manufacturer_name": ["Advanced Biomedical Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".33 mL in 1 BOTTLE (85131-013-00)", "package_ndc": "85131-013-00", "marketing_start_date": "20241218"}, {"sample": false, "description": "60 mL in 1 BOTTLE (85131-013-02)", "package_ndc": "85131-013-02", "marketing_start_date": "20241218"}, {"sample": false, "description": "118 mL in 1 BOTTLE (85131-013-04)", "package_ndc": "85131-013-04", "marketing_start_date": "20241218"}, {"sample": false, "description": "237 mL in 1 BOTTLE, PUMP (85131-013-08)", "package_ndc": "85131-013-08", "marketing_start_date": "20241218"}, {"sample": false, "description": "355 mL in 1 BOTTLE, PUMP (85131-013-12)", "package_ndc": "85131-013-12", "marketing_start_date": "20241218"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PUMP (85131-013-16)", "package_ndc": "85131-013-16", "marketing_start_date": "20241218"}], "brand_name": "Durashield", "product_id": "85131-013_b9f737e2-25dc-44cc-aa07-a5a77758473c", "dosage_form": "LOTION", "product_ndc": "85131-013", "generic_name": "benzalkonium chloride", "labeler_name": "Advanced Biomedical Incorporated", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Durashield", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".13 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241218", "listing_expiration_date": "20261231"}