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 56 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZING LAVENDERALCOHOLDR. BRONNER'S MAGIC SOAPS8383605a-0bac-428c-b1cb-2f95ce9bd35e2025-10-28WarningsExact identifier
application number: M003
ORGANIC HAND SANITIZER PEPPERMINTALCOHOLDR. BRONNER'S MAGIC SOAPScad3a81e-88cb-4f44-a351-b086fd9837952025-10-28WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421cfe98-7a20-c37c-e063-6294a90ad4b52025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce33e-4639-e881-e063-6394a90a57ef2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d994c-bf62-2f40-e063-6294a90a64882025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d2fd-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7bd9-c892-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.637dcb5f-8870-4613-a227-9fd6126170612025-10-27WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42143916-8d2e-dbbe-e063-6294a90a29c42025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42147184-18e6-f932-e063-6294a90a807e2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214ba08-8d00-8de9-e063-6394a90a4c902025-10-26WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214f0de-6b1d-dae7-e063-6294a90ade422025-10-26WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4215130c-a298-02c7-e063-6394a90a74ff2025-10-26WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd421b1732-acdd-a6cc-e063-6394a90a5fb42025-10-26WarningsExact 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