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 28 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AshleyBelle Moisturizing Hand Sanitizer Coconut Lime ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da93596-ec59-1e56-e063-6394a90afceb 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Island Vanilla ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da951ff-37fe-4ca4-e063-6394a90a4baf 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pink Sugar ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da9cb12-3aaf-c0f9-e063-6394a90ae4a4 2026-03-22 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Bellini Glow ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4da8a7b6-d147-87c3-e063-6394a90a784c 2026-03-22 Warnings Exact identifier application number: M003 ALCOHOL PREP AWABS ISOPROPYL ALCOHOL PATCH Henan Bingqing Yujie wipes Co., LTD 2e67e417-4dba-73a2-e063-6294a90aa4b2 2026-03-20 Warnings Exact identifier application number: M003 First Aid Antiseptic POVIDONE-IODINE Amazon.com Services LLC 3e2b255c-e3b7-468c-9ac1-b63279c5ac7f 2026-03-20 Warnings, Adverse reactions Exact identifier application number: M003 MediChoice OB Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. ed38fb97-b67d-430b-8f6b-4fc78c16aead 2026-03-17 Warnings Exact identifier application number: M003 MedPRIDE ISOPROPYL ALCOHOL Shield Line LLC f2177bd3-259d-4231-88b2-4a98e48e4df6 2026-03-17 Warnings Exact identifier application number: M003 MedPride 91% Rubbing Alcohol ISOPROPYL ALCOHOL Shield Line LLC e6ffe41e-efdc-0e0a-e053-2995a90a9e6a 2026-03-17 Warnings Exact identifier application number: M003 MedPRIDE with Wintergreen Oil ISOPROPYL ALCOHOL Shield Line LLC 57ac1a5c-758a-4422-8795-40391584434a 2026-03-17 Warnings Exact identifier application number: M003 NOVITA ISOPROPYL ALCOHOL 50% ISOPROPYL ALCOHOL Shield Line LLC 3ad79e91-377d-6587-e054-00144ff8d46c 2026-03-17 Warnings Exact identifier application number: M003 NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREEN ISOPROPYL ALCOHOL Shield Line LLC 3bd9fc61-b135-51f5-e054-00144ff8d46c 2026-03-17 Warnings Exact identifier application number: M003 Walgreens Burn Gel Packettes BURN GEL PACKETTES Walgreens 3fa09045-d4c0-8119-e063-6394a90ab6a0 2026-03-17 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Pink Satin Prosecco ALCOHOL Scent Theory Products LLC 4d278204-9331-aeb8-e063-6394a90a87a4 2026-03-16 Warnings Exact identifier application number: M003 Limited Edition Hand Sanitizer Cherry Chai ALCOHOL Scent Theory Products LLC 4d27a964-6e91-27c0-e063-6294a90ad994 2026-03-16 Warnings Exact identifier application number: M003 HealthWise Advanced Hand Sanitizer with Lavender ETHYL ALCOHOL 70% Veridian Healthcare 4d144fb3-b4b7-135f-e063-6394a90a366e 2026-03-15 Warnings Exact identifier application number: M003 Biopure Alcohol Cotton Swabs ISOPROPYL ALCOHOL, COTTON SWAB QUEST USA CORP 3a60362b-b397-da15-e063-6394a90a45ff 2026-03-15 Warnings Exact identifier application number: M003 BIOPURE20CT ANTI BACTERIAL HAND WIPES(2010C) ANTIBACTERIAL HAND WIPE Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. a9318c76-7c41-1634-e053-2a95a90a6d44 2026-03-13 Warnings Exact identifier application number: M003 Iodine IODINE Nice-Pak Products, LLC 857f13fe-51c9-4e5b-b5e2-a981dedabf71 2026-03-12 Warnings, Adverse reactions Exact identifier application number: M003 Limited Edition Hand Sanitizer Cashmere Skin ALCOHOL Scent Theory Products LLC 4cdc4282-eb49-3120-e063-6294a90a2d61 2026-03-12 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