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 108 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Latalia Sanitizing Wipes ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD af850b5e-c99f-3d4e-e053-2995a90a7948 2024-01-10 Warnings Exact identifier application number: M003 Latalia Alcohol Antiseptic 80 Sanitizing ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD ba4b8fb3-09db-fa29-e053-2995a90a8617 2024-01-10 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit--GI Dept ALCOHOL ASP Global, LLc c284eba4-0b92-4981-b3f8-d8d99b58bdfd 2024-01-10 Warnings Exact identifier application number: M003 Meijer 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Meijer, Inc. 33143d87-3e57-4a17-a96c-b699ad034b5b 2024-01-09 Warnings Exact identifier application number: M003 Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic ISOPROPYL ALCOHOL Meijer, Inc 2046162f-cb70-416c-ae37-14999883a807 2024-01-09 Warnings Exact identifier application number: M003 Lightning X Antiseptic BENZALKONIUM CHLORIDE Nantong Health & Beyond Hygienic Products Inc. 0e6b10e7-6e84-6bfc-e063-6294a90a8537 2024-01-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE 3.0% Trifecta Pharmaceuticals USA, LLC. e4e45f11-7cd4-e693-e053-2a95a90a4c34 2024-01-02 Warnings Exact identifier application number: M003 GLOBAL CARE GOLD ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 27ba0f30-e066-f240-e063-6394a90ae7cb 2024-01-01 Warnings Exact identifier application number: M003 Freskaro Decolorized Iodine ALCOHOL Pharma Nobis, LLC fbd222a2-1151-99b9-e053-6394a90a8bb8 2023-12-28 Warnings Exact identifier application number: M003 Alcohol Prep ISOPROPYL ALCOHOL Topco Associates 65270825-48b1-49e7-a14e-f73df9beb9dd 2023-12-27 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Pharma Nobis, LLC e42f876d-0477-c4d5-e053-2a95a90ae6d4 2023-12-26 Warnings Exact identifier application number: M003 Ethyl Rubbing Alcohol 70 Percent ETHYL ALCOHOL Pharma Nobis, LLC e42fccc2-1b50-e7f3-e053-2a95a90aef39 2023-12-26 Warnings Exact identifier application number: M003 Isopropyl Alcohol 70 Percent With Wintergreen Oil ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f6c6d-c4e1-02c6-e053-2995a90a3ace 2023-12-26 Warnings Exact identifier application number: M003 CVS Merthiolate BENZALKONIUM CHLORIDE CVS Pharmacy dd498ab1-8350-41aa-86fc-2db57005f3e2 2023-12-22 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Pharma Nobis, LLC e42eee1b-3539-fb17-e053-2995a90af61d 2023-12-22 Warnings Exact identifier application number: M003 Decolorized Iodine ETHYL ALCOHOL Pharma Nobis, LLC e21dd43b-3712-cb16-e053-2a95a90ac276 2023-12-22 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70 Percent ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f727c-beb0-fe9d-e053-2995a90aafea 2023-12-22 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE GARGLE 0.5% Pharma Nobis, LLC e42ee827-b350-7b56-e053-2a95a90a69cf 2023-12-22 Warnings Exact identifier application number: M003 Merthiolate BENZALKONIUM CHLORIDE Pharma Nobis, LLC e42f727c-beaf-fe9d-e053-2995a90aafea 2023-12-22 Warnings Exact identifier application number: M003 Isopropyl Alcohol 91 Percent ISOPROPYL ALCOHOL Pharma Nobis, LLC e42f6c6d-c4e0-02c6-e053-2995a90a3ace 2023-12-22 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