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 100 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up 2-in-1 Hand SanitizerBENZETHONIUM CHLORIDETARGET CORPORATIONe069c9e6-024d-5482-e053-2995a90a767d2024-10-14WarningsExact identifier
application number: M003
Meridian Wrapped antibacterial DeodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.7c834c1d-7930-4909-a600-6de9698e2b172024-10-14WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial DeodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.adc10d22-a913-4bfa-a3f7-d6d5778f07ca2024-10-14WarningsExact identifier
application number: M003
First Aid Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Changjian Medical Products Co., Ltd.9cb3759a-35d9-4f6b-94ad-fafd4bc600bd2024-10-11WarningsExact identifier
application number: M003
Antiseptic ToweletteBENZALKONIUM CHLORIDEHubei Changjian Medical Products Co., Ltd.bf045881-9636-4000-a0ac-f6aab6b818322024-10-11WarningsExact identifier
application number: M003
Antiseptic Povidone-lodine Prep PadPOVIDONE-IODINEHubei Changjian Medical Products Co., Ltd.2cacf2e0-0192-4e0f-88a6-e3eee3af54712024-10-11WarningsExact identifier
application number: M003
AntisepticETHANOLMcKesson6637290d-6ae4-5a83-e053-2991aa0a81c62024-10-11WarningsExact identifier
application number: M003
AntibacterialBENZETHONIUM CHLORIDEMcKesson58892abf-e0b9-83d9-e053-2a91aa0ad0352024-10-11WarningsExact identifier
application number: M003
AntibacterialBENZETHONIUM CHLORIDEMcKesson588a89cd-9481-6163-e053-2991aa0a9e3d2024-10-11WarningsExact identifier
application number: M003
McKesson Obstetrical Antiseptic ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgical51a3dabe-25d3-47fd-b640-83e68f7e06de2024-10-11WarningsExact identifier
application number: M003
McKesson Benzalkonium Chloride ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgicalcea36a9e-aac3-4494-a713-1dc64272d99c2024-10-11WarningsExact identifier
application number: M003
Alcohol Disinfecting WipeALCOHOLMcKesson Medical-Surgical64a0063d-a5da-4a46-9dca-16e4dbdac85c2024-10-11WarningsExact identifier
application number: M003
Mckesson Hand Cleanse and Soothe with AloeCHLOROXYLENOLMckesson Medical-Surgical Inc.075cd889-948a-49dd-8927-e22f7a5bff992024-10-10WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc07a891a3-dcf7-438f-bbf7-a20b2aa7d7d72024-10-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc0933de73-94b1-448e-b39f-ecffabf952882024-10-09WarningsExact identifier
application number: M003
EVERSOFT FOAMING HAND ANTI-BACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.e9d4767b-21f2-b68f-e053-2995a90a5aba2024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ALCOHOL FOAMALCOHOLDraco Hygienic Products Inc.14860a19-e1e8-71fc-e063-6394a90a9df82024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ANTIBACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.15256355-29ef-9b24-e063-6294a90a907d2024-10-08WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.4d156264-566d-4516-876c-b6f5823a97f52024-10-04WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.9d3a4dfe-f31d-4def-bfc2-ece69d13f8e42024-10-04WarningsExact 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