FDA.reportPublic FDA data

American Red Cross First Aid

Product NDC
51628-0368
11-digit product format
516280368
Labeler code
51628
Product ID
51628-0368_5c2ae529-5d5e-9470-e063-6394a90a94d3
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
MY IMPORTS USA, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Marketing end
2028-06-19
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 40 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 First Aid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL
LIDOCAINE HYDROCHLORIDE40 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-0368-0American Red Cross First Aid88.72 mL in 1 BOTTLESPRAY88.721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-0368AMERICAN RED CROSS FIRST AID (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [MY IMPORTS USA, LLC]1Current NDC, 1 package rows20250503_667ab8ce-e110-4b7f-a158-3cdd3b7a1c29.zip

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 61 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Lift Antibacterial Body WashBENZALKONIUM CHLORIDESpa de Soleilab9dde33-1bd2-062f-e053-2a95a90a4d182025-10-10WarningsExact identifier
application number: M003
Dr Lift AntibacterialBENZALKONIUM CHLORIDESpa de Soleilaf89675e-e66f-0922-e053-2995a90ab9d22025-10-10WarningsExact identifier
application number: M003
ANTISEPTIC WIPE 01BENZALKONIUM CHLORIDETotal Resources International Inc.cf4a6a97-529e-7f11-e053-2a95a90a75a92025-10-10WarningsExact identifier
application number: M003
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
application number: M003
CuradISOPROPYL ALCOHOLMedline Industries, LPc42de981-4e3f-1ac9-e053-2995a90aea982025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
application number: M003
MediChoice BZK AntisepticBENZALKONIUM CHLORIDEO&M HALYARD, INC.82a7710d-a9fa-4f68-8322-046a765ae9292025-10-08WarningsExact identifier
application number: M003
MediChoice CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.79d41cf0-301f-44d4-a76c-f4850c7ddce92025-10-08WarningsExact identifier
application number: M003
MediChoice Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLO&M HALYARD, INC.8b84c8ed-040e-4c07-94cb-d5bdda7446482025-10-08WarningsExact identifier
application number: M003
MediChoice of Hydrogen Peroxide 3 10 VolumeHYDROGEN PEROXIDEO&M HALYARD, INC.34e77ef4-297d-4362-8f6e-abf80158b7f02025-10-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEO&M HALYARD, INC.0ad5990a-a18d-4753-826b-6da3139266982025-10-08WarningsExact identifier
application number: M003
equate SwabsticksISOPROPYL ALCOHOLWalmart Inc.cd4a4490-bb02-436d-853b-f73261d358c62025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEFoodhold USA1e897ee5-17e3-459e-88e3-d7436ee22f372025-10-07WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEPremier Brands of America Inc.051b68f9-5d6c-3cd7-e063-6394a90aeb352025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHEB40b71196-a2ac-4a44-8046-c448d066baa22025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEAmerisourceBergen Drug Corporation5c82c4db-258e-4647-aec9-1c4520e0468a2025-10-07WarningsExact identifier
application number: M003
Premier Solutions Liquid BandageBENZETHONIUM CHLORIDE DYCLONINE HYDROCHLORIDEPremier Brands of America, Inc.e196d4c2-a93e-a03c-e053-2995a90a3ea32025-10-07WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEWinCo Foods LLC15d855fe-491e-4982-e063-6394a90aea1d2025-10-07WarningsExact identifier
application number: M003
LOCKE TEDDYALCOHOL ANTISEPTICKINGKEY MBC LIFE TECHNOLOGY GROUP CO.,LTD7c0056c1-3add-49f6-8816-b61a7f5a05082025-10-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN667ab8ce-e110-4b7f-a158-3cdd3b7a1c291
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD667ab8ce-e110-4b7f-a158-3cdd3b7a1c291
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY667ab8ce-e110-4b7f-a158-3cdd3b7a1c291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51628-0368-05162803680088.72 mL in 1 BOTTLE (51628-0368-0) 88.72 ml2025-05-012028-06-19NoNoHistorical