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 61 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Hand Sanitizer Lakeshore FreshALCOHOLShenzhen Lantern Scicence Co.,Ltd.41533b69-05e7-d5f7-e063-6294a90a2d2b2025-10-16WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.4153ac2a-e51c-f167-e063-6394a90a80d82025-10-16WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.412e961a-b7d4-b1c2-e063-6294a90a6b852025-10-15WarningsExact identifier
application number: M003
equate First Aid AntisepticPOVIDONE-IODINEWalmart Inc.43bbedec-be30-482a-8552-949b13d4bea12025-10-14WarningsExact identifier
application number: M003
TridergelBENZALKONIUM CHLORIDETrifluent Pharma LLCf12d9e8c-1d69-49d9-a9e9-a392c681aa6c2025-10-13WarningsExact identifier
application number: M003
Be Smart Get Prepared Sting Relief WipeBENZOCAINE, ALCOHOLTotal Resources International, Inc5415073f-aa1d-4ed3-aa30-7470cd2efed12025-10-10WarningsExact identifier
application number: M003
Lemyn Organics Medical-Grade Hand SanitizerALCOHOLLemyn LLCb106289d-346a-74df-e053-2995a90aa4262025-10-10WarningsExact identifier
application number: M003
Dr Lift Antibacterial Body WashBENZALKONIUM CHLORIDESpa de Soleilab9dde33-1bd2-062f-e053-2a95a90a4d182025-10-10WarningsExact identifier
application number: M003
Dr Lift AntibacterialBENZALKONIUM CHLORIDESpa de Soleilaf89675e-e66f-0922-e053-2995a90ab9d22025-10-10WarningsExact identifier
application number: M003
ANTISEPTIC WIPE 01BENZALKONIUM CHLORIDETotal Resources International Inc.cf4a6a97-529e-7f11-e053-2a95a90a75a92025-10-10WarningsExact identifier
application number: M003
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
application number: M003
CuradISOPROPYL ALCOHOLMedline Industries, LPc42de981-4e3f-1ac9-e053-2995a90aea982025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
application number: M003
Iodo Blanco (Iodine Tincture Decolorized) First Aid AntisepticIODINE 2%Germa Products, LLCbf54254f-2ef3-102e-e053-2995a90ac0832025-10-08WarningsExact identifier
application number: M003
MediChoice BZK AntisepticBENZALKONIUM CHLORIDEO&M HALYARD, INC.82a7710d-a9fa-4f68-8322-046a765ae9292025-10-08WarningsExact identifier
application number: M003
MediChoice CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.79d41cf0-301f-44d4-a76c-f4850c7ddce92025-10-08WarningsExact identifier
application number: M003
MediChoice Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLO&M HALYARD, INC.8b84c8ed-040e-4c07-94cb-d5bdda7446482025-10-08WarningsExact identifier
application number: M003
MediChoice of Hydrogen Peroxide 3 10 VolumeHYDROGEN PEROXIDEO&M HALYARD, INC.34e77ef4-297d-4362-8f6e-abf80158b7f02025-10-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEO&M HALYARD, INC.0ad5990a-a18d-4753-826b-6da3139266982025-10-08WarningsExact 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