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 40 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 Blueberry Freesia ETHYL ALCOHOL MY IMPORTS USA LLC 48f0a73a-66b5-e7d0-e063-6394a90a2333 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL MY IMPORTS USA LLC 48f127be-8259-5aaa-e063-6294a90a3f1a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Rose Lychee ETHYL ALCOHOL MY IMPORTS USA LLC 48f2433f-b924-ade1-e063-6394a90a2c9a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pineapple Soleil ETHYL ALCOHOL MY IMPORTS USA LLC 48f2527c-a83e-f709-e063-6394a90aa030 2026-01-21 Warnings Exact identifier application number: M003 DOP Hydrogen Peroxide 3% HYDROGEN PEROXIDE Omega & Delta Co. Inc. 73edab95-74ff-4f45-a941-634c83a52188 2026-01-21 Warnings Exact identifier application number: M003 DOP Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Omega & Delta Co., Inc. c779a35b-1118-4560-8d77-6878edb4c267 2026-01-21 Warnings Exact identifier application number: M003 Betadine Solution POVIDONE-IODINE Atlantis Consumer Healthcare, Inc. 1b1e224c-8c00-46ea-9bdd-020a9b45321d 2026-01-21 Warnings Exact identifier application number: M003 CVS Hydrogen Peroxide Wipes HYDROGEN PEROXIDE CVS Pharmacy d2c22ab0-9647-4025-8282-6b492209b04c 2026-01-20 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes ALCOHOL Germs Be Gone LLC 2bd6249b-f215-7aa9-e063-6394a90a6580 2026-01-20 Warnings Exact identifier application number: M003 SPA HAND SANITIZER SUMMER LEMON ETHYL ALCOHOL Rejoice International Corp. 48dd563a-0558-cc76-e063-6294a90ab041 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48de4a31-c620-6c1c-e063-6394a90abb96 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48df981a-74da-a629-e063-6294a90a7f40 2026-01-20 Warnings Exact identifier application number: M003 Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker Freeze ALCOHOL Scent Theory Products LLC 48c3d5e9-2d57-5a46-e063-6394a90a0722 2026-01-19 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487b648a-1680-6de5-e063-6394a90ab852 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487e6851-1ca3-f9db-e063-6394a90a56f1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. c3f0556d-f967-4f19-922c-57a2bf184892 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America 3b5b46d0-308a-4649-8384-246da3a18ba1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America bf69cc74-ebe9-40c3-a95a-a489492cc693 2026-01-16 Warnings Exact identifier application number: M003 NEXXGEN 50% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC d48232ab-ab55-488a-9cc1-77c8d0ba992e 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 486ee2e0-2222-0574-e063-6294a90a9eff 2026-01-15 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