FDA.reportPublic FDA data

ELLEN HAND SANITIZER

Product NDC
85537-101
11-digit product format
855370101
Labeler code
85537
Product ID
85537-101_33077eab-e687-249d-e063-6394a90a1b6d
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
2025-04-18
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 SANITIZER
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
33077eab-e686-249d-e063-6394a90a1b6dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85537-101-01ELLEN HAND SANITIZER100 mL in 1 BOTTLE, SPRAYSPRAY1001
85537-101-11ELLEN HAND SANITIZER40 in 1 BOXSPRAY401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85537-101ELLEN HAND SANITIZER (ETHYL ALCOHOL) SPRAY [PT. SUPER HOME PRODUCT INDONESIA]1Current NDC, 2 package rows20250419_33077eab-e686-249d-e063-6394a90a1b6d.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 2 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-21WarningsExact identifier
application number: M005
GPPEE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.598d05bc-459d-71cf-e063-6394a90a19322026-08-21WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
application number: M005
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
application number: M005
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
application number: M005
BYT BANGYTONG FOLLICULITIS5% BENZOYL PEROXIDE FOLLICULITISShenzhen Jindali Technology Co., Ltd595363f9-6aee-93a5-e063-6394a90a0f0e2026-08-18WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEShield Line LLC9ddb13cd-34ed-2d63-e053-2a95a90ad9da2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESTOLNAFTATEYunqi Cosmetics (Shenzhen) Co., Ltd5939c492-6481-ddae-e063-6294a90a40bb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
application number: M005
APUREE Maximum Strength Athletes Foot AntifungalAPUREE MAXIMUM STRENGTH ATHLETES FOOT ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.593dc9a3-ae04-5642-e063-6294a90adb4b2026-08-17WarningsExact identifier
application number: M005
MENTOL CHINO FORTEMETHYL SALICYLATE, MENTHOL, CAMPHORLABORATORIOS H.G. C.A.12652c98-e2a8-21fc-e063-6394a90a94cb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367692ethanol 60 % Topical SprayPSN33077eab-e686-249d-e063-6394a90a1b6d1
1367692ethanol 0.6 ML/ML Topical SpraySCD33077eab-e686-249d-e063-6394a90a1b6d1
1367692ethanol 60 % Topical SpraySY33077eab-e686-249d-e063-6394a90a1b6d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85537-101-0185537010101100 mL in 1 BOTTLE, SPRAY100 mlHistorical
85537-101-118553701011140 BOTTLE, SPRAY in 1 BOX (85537-101-11) / 100 mL in 1 BOTTLE, SPRAY (85537-101-01) 2025-04-18NoNoCurrent