FDA.reportPublic FDA data

germstarONE unscented

Product NDC
57915-021
11-digit product format
579150021
Labeler code
57915
Product ID
57915-021_29a593b8-ff9f-bc5c-e063-6394a90a52cc
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Soaptronic, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-30
Substance
ALCOHOL
Active strength
630 g/1000g
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
germstarONE unscented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL630 g/1000g

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
1041807Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6a798bd-09cb-1853-e053-2995a90a27f9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-021-01germstarONE unscented946 g in 1 BAGSOLUTION94611
57915-021-02germstarONE unscented474 g in 1 BOTTLE, PUMPSOLUTION47411
57915-021-03germstarONE unscented236 g in 1 BOTTLE, SPRAYSOLUTION23611
57915-021-04germstarONE unscented59 g in 1 BOTTLE, SPRAYSOLUTION5911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-021GERMSTARONE UNSCENTED (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]11Current NDC, Legacy NDC, 4 package rows20241225_a6a798bd-09cb-1853-e053-2995a90a27f9.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 77 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a68ecb-3216-eeb2-e063-6294a90a5bba2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%MY IMPORTS USA LLC36a7b358-131c-88fc-e063-6394a90a007f2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a7bbf0-166b-54dc-e063-6294a90a1c162025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Blissful Cherry, Candy Cane Cocoa, Molten Marshmallows)ALCOHOLScent Theory Products LLC36b0eec0-33b2-2055-e063-6394a90af7302025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Pink Champagne, Harvest Berry, Cozy Coconut)ALCOHOLScent Theory Products LLC36b105ef-82a5-7f95-e063-6394a90a8c1b2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%MY IMPORTS USA LLC36b4fb1c-9b19-63c3-e063-6394a90a5e352025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b55178-6f31-85a9-e063-6394a90a56bc2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b5ebda-1448-bc40-e063-6294a90af6d42025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b63138-8ec9-e84a-e063-6394a90a68e32025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%MY IMPORTS USA LLC36b6d0e4-8d9f-9df5-e063-6294a90af3262025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%MY IMPORTS USA LLC36b71ebe-0638-73e8-e063-6394a90a9f4e2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%MY IMPORTS USA LLC36b73e99-293a-865b-e063-6394a90a39c42025-06-03WarningsExact identifier
application number: M003
Biopure 3 Hydrogen PeroxideHYDROGEN PEROXIDEQuest USA Corp1e34d066-f82c-484c-87bf-aa54fb1fac072025-06-02WarningsExact identifier
application number: M003
Simply Saline Wound CareBENZETHONIUM CHLORIDE 0.13%Church & Dwight Co., Inc.6c802e91-b69e-cdd0-e053-2991aa0aa7812025-06-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a5a4a2-983e-a4e7-e063-6394a90aa27c2025-06-01WarningsExact identifier
application number: M003
BerbereX Wound CleanserBENZETHONIUM CHLORIDECosco International, Inc.08b28f52-21fc-4694-a163-91c8193b40082025-05-30WarningsExact identifier
application number: M003
Op-First Aid Series Povidone Iodine Prep PadPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.32dc994b-6636-72d8-e063-6294a90a98f62025-05-29WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Apple Pear CloveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.363e549a-c432-9f2e-e063-6394a90ae8862025-05-28WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Incc2822eb6-8a2a-4337-acce-6f7fc84961752025-05-26WarningsExact identifier
application number: M003
VLITEPRO First Aid WipesISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co., Ltd.35a7873a-e340-aae3-e063-6294a90a767f2025-05-26WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041807alcohol 63 % Topical SolutionPSNa6a798bd-09cb-1853-e053-2995a90a27f911
1041807ethanol 0.63 ML/ML Topical SolutionSCDa6a798bd-09cb-1853-e053-2995a90a27f911
1041807ethanol 63 % Topical SolutionSYa6a798bd-09cb-1853-e053-2995a90a27f911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-021-0157915002101946 g in 1 BAG (57915-021-01) 946 g2020-04-300000-00-00NoNoCurrent
57915-021-0257915002102474 g in 1 BOTTLE, PUMP (57915-021-02) 474 g2020-04-300000-00-00NoNoCurrent
57915-021-0357915002103236 g in 1 BOTTLE, SPRAY (57915-021-03) 236 g2020-04-300000-00-00NoNoCurrent
57915-021-045791500210459 g in 1 BOTTLE, SPRAY (57915-021-04) 59 g2020-04-300000-00-00NoNoCurrent