FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
52854-600
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 5 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
application number: M003
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
application number: M003
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
application number: M003
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
application number: M003
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
application number: M003
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M003
antibacterial hand wipes (JUICY WATERMELON)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.5883c43d-212b-af39-e063-6394a90ad6522026-08-08WarningsExact identifier
application number: M003
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
application number: M003
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
application number: M003
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact 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
52854-600-0252854060002119 mL in 1 BOTTLE (52854-600-02) 119 ml2009-03-280000-00-00NoNoCurrent
52854-600-0352854060003237 mL in 1 BOTTLE, PUMP (52854-600-03) 237 ml2009-03-280000-00-00NoNoCurrent
52854-600-0452854060004250 mL in 1 BOTTLE (52854-600-04) 250 ml2009-03-280000-00-00NoNoCurrent
52854-600-05528540600051000 mL in 1 BOTTLE, PUMP (52854-600-05) 1000 ml2009-03-280000-00-00NoNoCurrent
52854-600-06528540600063785 mL in 1 JUG (52854-600-06) 3785 ml2009-03-280000-00-00NoNoCurrent