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 68 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation7560c80b-8952-4748-af3a-20e3d42556952025-09-08WarningsExact identifier
application number: M003
Green Guard Derma-Caine BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation67629392-7e02-321a-e053-2991aa0a0f242025-09-08WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb3ef1ef5-1f6f-874a-e053-2995a90a32b12025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationa0f58025-2c50-45dc-94db-cacbd4cf604c2025-09-08WarningsExact identifier
application number: M003
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
application number: M003
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationb4627f3f-6282-51bf-e053-2a95a90a3d592025-09-08WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb463d09c-4b33-3774-e053-2a95a90a046b2025-09-08WarningsExact identifier
application number: M003
Thompson Burn Cream with LidocainBENZALKONIUM CHLORIDE, LIDOCAINEThompson Safety11729e6b-b911-5c1f-e063-6394a90a0c342025-09-08WarningsExact identifier
application number: M003
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2869cb20-9cd4-54f5-e063-6294a90a5fea2025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.28694168-3362-de4f-e063-6394a90a2e352025-09-05WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e0a5382-7b58-fd6e-e063-6394a90abf662025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e09c0aa-0241-0816-e063-6294a90a481e2025-09-05WarningsExact identifier
application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3080d8a2-a780-e79b-e063-6294a90ac6542025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3081e1b5-66b4-77a8-e063-6394a90a8dd32025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30847dd5-e378-1a35-e063-6294a90a43da2025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3084d980-29ca-91ca-e063-6294a90a6c672025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3099e6af-8072-d26b-e063-6394a90a39ef2025-09-05WarningsExact 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