FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
52854-600
Requested package NDC
52854-600-01
11-digit product format
528540600
Labeler code
52854
Product ID
52854-600_42c995c5-fd32-3792-e063-6294a90ae700
Type
HUMAN OTC DRUG
Nonproprietary name
SDA 40B Alcohol 200 Proof
Dosage form
LIQUID
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-03-28
Substance
ALCOHOL
Active strength
64.325 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL64.325 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2468410Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b48f9afa-1634-e63e-e053-2a95a90a32bfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-600-01Hand Sanitizer60 mL in 1 BOTTLELIQUID606
52854-600-02Hand Sanitizer119 mL in 1 BOTTLELIQUID1196
52854-600-03Hand Sanitizer237 mL in 1 BOTTLE, PUMPLIQUID2376
52854-600-04Hand Sanitizer250 mL in 1 BOTTLELIQUID2506
52854-600-05Hand Sanitizer1000 mL in 1 BOTTLE, PUMPLIQUID10006
52854-600-06Hand Sanitizer3785 mL in 1 JUGLIQUID37856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-600HAND SANITIZER (SDA 40B ALCOHOL 200 PROOF) LIQUID [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 6 package rows20241103_b48f9afa-1634-e63e-e053-2a95a90a32bf.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 49 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuickMendBENZETHONIUM CHLORIDEEquibal, Inc.9b0c85a4-9727-4940-a934-0b81a7c938cf2025-12-17WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0ef369-a0e7-5320-e063-6394a90a353f2025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC45c3c6da-5217-5c2b-e063-6294a90a56d32025-12-12WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZERALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd1abf5aca-346f-0d18-e063-6294a90a93392025-12-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2468410ethanol 64.3 % Topical SolutionPSNb48f9afa-1634-e63e-e053-2a95a90a32bf6
2468410ethanol 0.643 ML/ML Topical SolutionSCDb48f9afa-1634-e63e-e053-2a95a90a32bf6
2468410ethanol 64.3 % Topical SolutionSYb48f9afa-1634-e63e-e053-2a95a90a32bf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-600-015285406000160 mL in 1 BOTTLE (52854-600-01) 60 ml2009-03-280000-00-00NoNoCurrent