FDA.reportPublic FDA data

ELLEN HAND SANITIZER2

Product NDC
85537-102
11-digit product format
855370102
Labeler code
85537
Product ID
85537-102_334574b6-6d4b-bd37-e063-6394a90a67d6
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
PT. SUPER HOME PRODUCT INDONESIA
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-21
Substance
ALCOHOL
Active strength
60 mL/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
ELLEN HAND SANITIZER2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL60 mL/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
1367692Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
334574b6-6d4a-bd37-e063-6394a90a67d6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85537-102-02ELLEN HAND SANITIZER245 mL in 1 BOTTLE, SPRAYSPRAY451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85537-102ELLEN HAND SANITIZER2 (ETHYL ALCOHOL) SPRAY [PT. SUPER HOME PRODUCT INDONESIA]1Current NDC, 1 package rows20250422_334574b6-6d4a-bd37-e063-6394a90a67d6.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 32 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arflom Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.413e76b5-263c-62fa-e063-6294a90a92142025-10-15WarningsExact identifier
application number: M005
VTROUY Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.413f6399-dda1-8dd9-e063-6394a90a573d2025-10-15WarningsExact identifier
application number: M005
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Incf647308a-ea6c-47a9-a124-60e7888afac22025-10-14WarningsExact identifier
application number: M005
Tripenicol SUNDECYLENIC ACIDTrifluent Pharma LLCb57500e1-ea6f-4043-99d6-326a7eb57f2f2025-10-14WarningsExact identifier
application number: M005
TriTolnacide CTOLNAFTATETrifluent Pharma LLC12b53c2a-b073-43db-88d9-ede8300626aa2025-10-14WarningsExact identifier
application number: M005
Tritolnacide STOLNAFTATETrifluent Pharma LLCb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d82025-10-14WarningsExact identifier
application number: M005
Tripenicol CUNDECYLENIC ACIDTrifluent Pharma LLC0a7477da-370f-451f-8993-8c675c1686962025-10-14WarningsExact identifier
application number: M005
Povidone-Iodine PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
application number: M005
seebeellar antifungal cream 2% miconazoleSEEBEELLAR ANTIFUNGAL CREAM 2% MICONAZOLEGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd40c491f6-43b4-534e-e063-6294a90a73d62025-10-09WarningsExact identifier
application number: M005
Hermon Antifungal Jock Itch Body WashTOLNAFTATE 1%Beautivity LLC409ef5c0-dfe5-f26a-e063-6294a90a27452025-10-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEMarlex Pharmaceuticals Incd6e95c99-e055-436a-8ee6-40d6e199eaca2025-10-08WarningsExact identifier
application number: M005
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
application number: M005
antibacterial body washSILVERGuangdong Quaker Daily Chemical Co., LTD3fff8d3e-1944-4813-e063-6294a90a1a1d2025-09-30WarningsExact identifier
application number: M005
Tobcharm Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.4001247d-4704-8786-e063-6394a90a083a2025-09-30WarningsExact identifier
application number: M005
Silka AntifungalTOLNAFTATEGenomma Lab USAfb1dc636-837f-491c-97c1-e74288aebc272025-09-30WarningsExact identifier
application number: M005
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.3d48a3c6-b7d6-6794-e063-6294a90afff92025-09-29WarningsExact identifier
application number: M005
LEADER ATHLETES FOOT CLOTRIMAZOLECLOTRIMAZOLELEADERdcea717b-b097-4a40-8e38-05212731a7ef2025-09-29WarningsExact identifier
application number: M005
First Aid AntispeticBENZALKONIUM CHLORIDEUnishieldf72851ba-bbdd-5533-e053-6294a90a82162025-09-28WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe861cc-c972-a328-e063-6294a90afc8f2025-09-28WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal Foot CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe8fc55-bd64-a4a8-e063-6294a90ad18c2025-09-28WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367692ethanol 60 % Topical SprayPSN334574b6-6d4a-bd37-e063-6394a90a67d61
1367692ethanol 0.6 ML/ML Topical SpraySCD334574b6-6d4a-bd37-e063-6394a90a67d61
1367692ethanol 60 % Topical SpraySY334574b6-6d4a-bd37-e063-6394a90a67d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85537-102-028553701020245 mL in 1 BOTTLE, SPRAY (85537-102-02) 45 ml2025-04-21NoNoCurrent