FDA.reportPublic FDA data

American Red Cross Antiseptic Cleansing

Product NDC
51628-0035
11-digit product format
516280035
Labeler code
51628
Product ID
51628-0035_5c2ad816-f987-6557-e063-6394a90a3c7b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
MY IMPORTS USA, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Marketing end
2028-12-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
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
American Red Cross Antiseptic Cleansing

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-0035-1American Red Cross Antiseptic Cleansing177 mL in 1 BOTTLE, PUMPSPRAY1772

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 71 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f8420-9673-6f77-e063-6294a90a81e42025-08-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3af609-d342-449a-e063-6294a90a0a192025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3bd802-56de-ebcd-e063-6294a90aca152025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild RoseALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3c78f6-e6cb-e456-e063-6394a90ac5b82025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c4bceac-21bc-486e-e063-6394a90a0f372025-08-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c25e093-0335-fa1d-e063-6394a90ae6842025-08-12WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c266de8-0551-374c-e063-6394a90ab9f42025-08-12WarningsExact identifier
application number: M003
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEHAIAN KANGRUI TEXTILE CO., LTD.3c273544-4562-8f37-e063-6394a90ab4d32025-08-12WarningsExact identifier
application number: M003
HealthWise Lidocaine CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEVeridian Healthcare6022803a-097e-41c6-b9ee-48c8ef380d7a2025-08-12WarningsExact identifier
application number: M003
Hand Sanitizer WipesISOPROPYL ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c37f72b-623c-c8f6-e063-6294a90a971e2025-08-12WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c236c0b-fccd-6992-e063-6294a90a37ce2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c2322e0-90d5-6ce6-e063-6394a90ac8bb2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c23d45e-9050-5b9e-e063-6294a90abd4a2025-08-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafetec of America, Inc.89310a64-c4cc-46c6-8294-c4d28cd881182025-08-08WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Citrus SunshineETHYL ALCOHOLWhole Foods Market, Inc.3bcf1071-2308-b989-e063-6294a90a68232025-08-07WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDELJ Pharmae468ad76-b26a-49f0-a2c5-a027299babc72025-08-05WarningsExact identifier
application number: M003
Armor Antibacterial Body Treatment Benzalkonium ChlorideBENZALKONIUM CHLORIDERida LLC95761213-bf90-4ba6-a17b-7470a0f316232025-08-05WarningsExact identifier
application number: M003
AerowipeANSTISEPTIC WIPEAero Healthcare34ca12c7-9281-263c-e054-00144ff8d46c2025-08-01WarningsExact identifier
application number: M003
KeriCleanz ANTISEPTICHYDROGEN PEROXIDEKericure Inc.79b0d9bb-0fa5-4e45-ab74-9ff0e12152382025-07-31WarningsExact identifier
application number: M003
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN716da1e6-d0f5-4cc1-ad78-517d5ca809a52
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD716da1e6-d0f5-4cc1-ad78-517d5ca809a52
1039012benzalkonium chloride 0.13 % Topical SpraySY716da1e6-d0f5-4cc1-ad78-517d5ca809a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51628-0035-151628003501177 mL in 1 BOTTLE, PUMP (51628-0035-1) 177 ml2025-11-012028-12-01NoNoHistorical