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 61 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Hand Sanitizer Lakeshore Fresh ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 41533b69-05e7-d5f7-e063-6294a90a2d2b 2025-10-16 Warnings Exact identifier application number: M003 Meijer Hand Sanitizer Pine Forest ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4153ac2a-e51c-f167-e063-6394a90a80d8 2025-10-16 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 412e961a-b7d4-b1c2-e063-6294a90a6b85 2025-10-15 Warnings Exact identifier application number: M003 equate First Aid Antiseptic POVIDONE-IODINE Walmart Inc. 43bbedec-be30-482a-8552-949b13d4bea1 2025-10-14 Warnings Exact identifier application number: M003 Tridergel BENZALKONIUM CHLORIDE Trifluent Pharma LLC f12d9e8c-1d69-49d9-a9e9-a392c681aa6c 2025-10-13 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe BENZOCAINE, ALCOHOL Total Resources International, Inc 5415073f-aa1d-4ed3-aa30-7470cd2efed1 2025-10-10 Warnings Exact identifier application number: M003 Lemyn Organics Medical-Grade Hand Sanitizer ALCOHOL Lemyn LLC b106289d-346a-74df-e053-2995a90aa426 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial Body Wash BENZALKONIUM CHLORIDE Spa de Soleil ab9dde33-1bd2-062f-e053-2a95a90a4d18 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial BENZALKONIUM CHLORIDE Spa de Soleil af89675e-e66f-0922-e053-2995a90ab9d2 2025-10-10 Warnings Exact identifier application number: M003 ANTISEPTIC WIPE 01 BENZALKONIUM CHLORIDE Total Resources International Inc. cf4a6a97-529e-7f11-e053-2a95a90a75a9 2025-10-10 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe ALCOHOL, LIDOCAINE HYDROCHLORIDE Total Resources International, Inc fff6f057-739e-40f1-8427-e1364c65af05 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Zhejiang Hudson Import& Export Co., Ltd 40b6c96c-e36f-6588-e063-6394a90adb46 2025-10-09 Warnings Exact identifier application number: M003 Curad ISOPROPYL ALCOHOL Medline Industries, LP c42de981-4e3f-1ac9-e053-2995a90aea98 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Avaria Health & Beauty Corp a3d87ef6-752b-b54b-e053-2a95a90af963 2025-10-08 Warnings Exact identifier application number: M003 Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic IODINE 2% Germa Products, LLC bf54254f-2ef3-102e-e053-2995a90ac083 2025-10-08 Warnings Exact identifier application number: M003 MediChoice BZK Antiseptic BENZALKONIUM CHLORIDE O&M HALYARD, INC. 82a7710d-a9fa-4f68-8322-046a765ae929 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. 79d41cf0-301f-44d4-a76c-f4850c7ddce9 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL O&M HALYARD, INC. 8b84c8ed-040e-4c07-94cb-d5bdda744648 2025-10-08 Warnings Exact identifier application number: M003 MediChoice of Hydrogen Peroxide 3 10 Volume HYDROGEN PEROXIDE O&M HALYARD, INC. 34e77ef4-297d-4362-8f6e-abf80158b7f0 2025-10-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE O&M HALYARD, INC. 0ad5990a-a18d-4753-826b-6da313926698 2025-10-08 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