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 68 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUniforst First Aid Corporation5744f9a2-35c6-37df-e053-2991aa0a1ca92025-09-08WarningsExact identifier
application number: M003
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd2ccdd9a-469e-18eb-e053-2995a90a11962025-09-08WarningsExact identifier
application number: M003
Medi-First Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce650cb6-5398-29e7-e053-2995a90ac7972025-09-08WarningsExact identifier
application number: M003
MediFirst Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation8d17a840-b655-4e03-bc16-8ba033c3368d2025-09-08WarningsExact identifier
application number: M003
Medi-First Sting ReliefBENZOCAINE 6%, ISOPROPYL ALCOHOL 60%Unifirst First Aid Corporation6e610821-b030-930b-e053-2a91aa0a66f92025-09-08WarningsExact identifier
application number: M003
Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation81363387-d4b1-4c3f-b67f-5017361c0fcd2025-09-08WarningsExact identifier
application number: M003
Medi-First Isopropyl AlcoholISOPROPYL ALCOHOLUnifirst First Aid Corporationdbee035e-094f-f8a3-e053-2995a90a66202025-09-08WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbfbf8cf-201b-2277-e053-2995a90a6e452025-09-08WarningsExact identifier
application number: M003
Medi-First PVP Iodine WipesPOVIDONE IODINE 10%Unifirst-First Aid406b4a37-816a-5ea4-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation7560c80b-8952-4748-af3a-20e3d42556952025-09-08WarningsExact identifier
application number: M003
Green Guard Derma-Caine BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation67629392-7e02-321a-e053-2991aa0a0f242025-09-08WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb3ef1ef5-1f6f-874a-e053-2995a90a32b12025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationa0f58025-2c50-45dc-94db-cacbd4cf604c2025-09-08WarningsExact identifier
application number: M003
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
application number: M003
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationb4627f3f-6282-51bf-e053-2a95a90a3d592025-09-08WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb463d09c-4b33-3774-e053-2a95a90a046b2025-09-08WarningsExact identifier
application number: M003
Thompson Burn Cream with LidocainBENZALKONIUM CHLORIDE, LIDOCAINEThompson Safety11729e6b-b911-5c1f-e063-6394a90a0c342025-09-08WarningsExact identifier
application number: M003
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact 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