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 106 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe ETHYL ALCOHOL Rejoice International 2851ad2a-e108-424c-86d6-c898567695ef 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Hand Sanitizer Moisturize with Vitamin E ETHYL ALCOHOL Rejoice International 13c99570-0859-4310-843a-5eb266698eb3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International a339dfd9-7cb8-4198-bc2a-9759648cf34e 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72 2024-02-28 Warnings Exact identifier application number: M003 AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd 11ef87cc-6ff6-511b-e063-6294a90a662f 2024-02-21 Warnings Exact identifier application number: M003 AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER ETHYL ALCOHOL MY IMPORTS USA LLC 11f19126-6abb-b14c-e063-6294a90a4e34 2024-02-21 Warnings Exact identifier application number: M003 Antiseptic ANTISEPTIC SPRAY Dynarex Corporation 118192ac-7173-09c5-e063-6394a90ad550 2024-02-16 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL SPRAY Dynarex Corporation 116e0c9c-cbe0-bf67-e063-6394a90ae530 2024-02-15 Warnings Exact identifier application number: M003 POVIDONE-IODINE POVIDONE-IODINE HART Health 92b6a38e-c7bb-45e2-9c2a-7993ed1bac36 2024-02-15 Warnings Exact identifier application number: M003 Povidone Iodine Gel Swabstick POVIDONE IODINE GEL SWABSTICK Dynarex Corporation eb7e21be-521e-2d52-e053-2a95a90ade33 2024-02-13 Warnings Exact identifier application number: M003 Antiseptic ALCOHOL, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 71aeaf86-2b4d-4945-9606-a9db0ab6b726 2024-02-07 Warnings Exact identifier application number: M003 Antiseptic BENZALKONIUM CHLORIDE, BENZOCAINE Safetec of America, Inc. 458e65f2-826d-4550-8c7d-17add2d7ba9a 2024-02-07 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Safetec of America, Inc. a665e2ce-c7e1-4d79-aa58-da7595944e7f 2024-02-07 Warnings Exact identifier application number: M003 First Aid and Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 47cb6921-5d82-4123-a9e0-0b05d4dcb5b2 2024-02-07 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with vitamin E ETHYL ALCOHOL 70%V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 0fbf0078-3660-fe5c-e063-6394a90afc2d 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with aloe vera ETHYL ALCOHOL 70%V/V Midwood Brands, LLC 0fc032af-26bc-0e8b-e063-6294a90a91b0 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 16.9oz with vitamin E ETHYL ALCOHOL Midwood Brands, LLC 0fc0bd79-ddd7-b9d1-e063-6394a90adc69 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with vitamin E ETHYL ALCOHOL 70%V/V Midwood Brands, LLC 0fc0970d-06a6-ade9-e063-6394a90ae7ff 2024-01-25 Warnings Exact identifier application number: M003 Target Up and Up Pain Relieving Cleansing BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE TARGET CORPORATION 0f964747-be02-c715-e063-6294a90ad91e 2024-01-25 Warnings Exact identifier application number: M003 SannyTize Hand Sanitizer HAND SANITIZER Dynarex Corporation 968713a5-64d3-86fc-e053-2995a90a088a 2024-01-24 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