Home NDC 85754-000 Guardelle
Product NDC 85754-000
11-digit product format 857540000
Labeler code 85754
Product ID 85754-000_3a8774ed-4fdf-48b6-a54b-8db85492cb34
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Social Medical Supply LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-16
Substance BENZALKONIUM CHLORIDE
Active strength .13 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Guardelle
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020365 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85754-000-02 Guardelle 52 mL in 1 BOTTLE, PUMP AEROSOL, FOAM 52 1 85754-000-07 Guardelle 207 mL in 1 BOTTLE, PUMP AEROSOL, FOAM 207 1 85754-000-18 Guardelle 500 mL in 1 BOTTLE, PUMP AEROSOL, FOAM 500 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 72 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HAND SANITIZER VANILLA ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3c2322e0-90d5-6ce6-e063-6394a90ac8bb 2025-08-11 Warnings Exact identifier application number: M003 HAND SANITIZER VANILLA ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3c23d45e-9050-5b9e-e063-6294a90abd4a 2025-08-11 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Safetec of America, Inc. 89310a64-c4cc-46c6-8294-c4d28cd88118 2025-08-08 Warnings Exact identifier application number: M003 365 Whole Foods Market Refreshing Hand Sanitizer Citrus Sunshine ETHYL ALCOHOL Whole Foods Market, Inc. 3bcf1071-2308-b989-e063-6294a90a6823 2025-08-07 Warnings Exact identifier application number: M003 3% HYDROGEN PEROXIDE HYDROGEN PEROXIDE LJ Pharma e468ad76-b26a-49f0-a2c5-a027299babc7 2025-08-05 Warnings Exact identifier application number: M003 Armor Antibacterial Body Treatment Benzalkonium Chloride BENZALKONIUM CHLORIDE Rida LLC 95761213-bf90-4ba6-a17b-7470a0f31623 2025-08-05 Warnings Exact identifier application number: M003 Aerowipe ANSTISEPTIC WIPE Aero Healthcare 34ca12c7-9281-263c-e054-00144ff8d46c 2025-08-01 Warnings Exact identifier application number: M003 KeriCleanz ANTISEPTIC HYDROGEN PEROXIDE Kericure Inc. 79b0d9bb-0fa5-4e45-ab74-9ff0e1215238 2025-07-31 Warnings Exact identifier application number: M003 Caring Mill Alcohol Prep Pads ISOPROPYL ALCOHOL FSA Store Inc. 3b394791-0783-79e1-e063-6294a90ae8e7 2025-07-31 Warnings Exact identifier application number: M003 WICKED HAND SANITIZER WATERMELON ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0e9352-15c9-954a-e063-6294a90a7a67 2025-07-29 Warnings Exact identifier application number: M003 WICKED HAND SANITIZER STRAWBERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0e7e57-6472-6cca-e063-6294a90a63a6 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER COCONUT ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0f1b10-ed25-0949-e063-6394a90a6a80 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER MANGO ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0fd685-c807-75e4-e063-6394a90a3d65 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER PEACH ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b104177-be18-8b50-e063-6394a90a3b39 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER CHERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b4680c7-562f-c78b-e063-6294a90a5d1a 2025-07-29 Warnings Exact identifier application number: M003 Nourishing Sanitizing Hand Wipes Eucalyptus ALCOHOL SOLUTION Noshinku 3affe837-6789-6213-e063-6294a90a9fea 2025-07-28 Warnings Exact identifier application number: M003 Nourishing Sanitizing Hand Wipes Lavendula ALCOHOL SOLUTION Noshinku 3b0016b4-ccad-5eb5-e063-6294a90a36ca 2025-07-28 Warnings Exact identifier application number: M003 Nourishing Sanitizing Hand Wipes Bergamot ALCOHOL SOLUTION Noshinku 3b0035e8-d95e-f5f2-e063-6394a90aca01 2025-07-28 Warnings Exact identifier application number: M003 Kills Hand Sanitizer ALCOHOL Dermazone LLC ced12de7-32c1-4882-af22-f5373b2ceddb 2025-07-25 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3aab23c1-53ad-9e60-e063-6394a90a26ec 2025-07-24 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85754-000-02 85754000002 52 mL in 1 BOTTLE, PUMP (85754-000-02) 52 ml 2025-10-16 No No Current 85754-000-07 85754000007 207 mL in 1 BOTTLE, PUMP (85754-000-07) 207 ml 2025-10-16 No No Current 85754-000-18 85754000018 500 mL in 1 BOTTLE, PUMP (85754-000-18) 500 ml 2025-10-16 No No Current