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 70 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
I-70 FoamingALCOHOL SANITIZERPeople's Janitorial Supply3cbabb95-c72f-6984-e063-6294a90adae02025-08-19WarningsExact identifier
application number: M003
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edaff0ca-f305-71a4-e053-2a95a90a5dca2025-08-18WarningsExact identifier
application number: M003
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edb4a43a-5b55-3404-e053-2a95a90ada272025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - SOURBETALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9fe5a6-a729-4710-e063-6294a90a0da12025-08-18WarningsExact identifier
application number: M003
Premium Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.13d42582-df02-41d5-bada-1d67c61310152025-08-18WarningsExact identifier
application number: M003
MedPride Povidone Iodine Scrub Solution Skin CleanserPOVIDONE-IODINEShield Line LLC88dfef39-c6c2-44fc-e053-2995a90a805a2025-08-18WarningsExact identifier
application number: M003
MedPride Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEShield Line LLC88cb1b8d-3dae-be00-e053-2995a90a0d112025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - Romance GourmondALCOHOLShenzhen Lantern Scicence Co.,Ltd.3caf5726-8d4c-9d36-e063-6294a90a3cf12025-08-18WarningsExact identifier
application number: M003
Hand Sanitizer plus Serum EdenALCOHOLMoam LLC93c9f1ad-e08a-4859-bf24-db37e6b1d3082025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9c71e5-fe7a-d342-e063-6294a90a774a2025-08-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c76e629-96a0-7031-e063-6294a90a05ae2025-08-16WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.394e4b3a-5832-9f8d-e063-6294a90ac4492025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Botanic BlushALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62434b-c2a9-bd39-e063-6294a90af8b32025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Golden GroveALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62805a-7834-8a27-e063-6394a90a67fe2025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Citrus SuedeALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62ecc5-4252-a002-e063-6394a90ace3e2025-08-15WarningsExact identifier
application number: M003
AmeriDerm Antibacterial WashPARACHLOROMETAXYLENOLSHIELD LINE LLC6e652a7d-76bb-bb2d-e053-2a91aa0aac502025-08-15WarningsExact identifier
application number: M003
AMERIWASHPARACHLOROMETAXYLENOLSHIELD LINE LLC6d5ed0f9-fb48-7855-e053-2991aa0a18a82025-08-15WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Bergamot RainETHYL ALCOHOLWhole Foods Market, Inc.3c6b1a51-4097-1aad-e063-6294a90aef6f2025-08-15WarningsExact identifier
application number: M003
MedPride Bath WipesBENZALKONIUM CHLORIDEShield Line LLCecf7e545-21ca-bbe0-e053-2995a90a9a552025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f46b4-f202-2a44-e063-6294a90ac1062025-08-14WarningsExact 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