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 70 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.3cf2ff12-0220-3307-e063-6394a90abf082025-08-22WarningsExact identifier
application number: M003
Chain Drug Marketing Association, Inc.ISOPROPYL ALCOHOLChain Drug Marketing Association Inc.18fe4787-8986-4d64-e063-6394a90a35132025-08-22WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Eucalyptus AloeALCOHOLScent Theory Products LLC3cf7e175-239d-e13b-e063-6294a90a79062025-08-22WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Sunrise GlowALCOHOLScent Theory Products LLC3cf7fce1-3112-0d66-e063-6294a90a98652025-08-22WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7d0e8-12b4-e410-e053-2a95a90a7f302025-08-21WarningsExact identifier
application number: M003
American Red Cross 3 Hydrogen PeroxideHYDROGEN PEROXIDEMY IMPORTS USA LLCde46ffc7-3b66-dd8b-e053-2a95a90a28d82025-08-21WarningsExact identifier
application number: M003
Antibacterial Hand wipesBENZALKONIUM CHLORIDEMY IMPORTS USA LLC2ba77bab-7d02-d7c7-e063-6294a90aae872025-08-19WarningsExact identifier
application number: M003
SANITIZING HAND WIPESSANITIZING HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.3cb82a83-3067-80a6-e063-6394a90a8ab02025-08-19WarningsExact identifier
application number: M003
MedPride PrepPadsPOVIDONE IODINEShield Line LLC289e92a2-f03f-4b8a-e054-00144ff8d46c2025-08-19WarningsExact identifier
application number: M003
I-70 FoamingALCOHOL SANITIZERPeople's Janitorial Supply3cbabb95-c72f-6984-e063-6294a90adae02025-08-19WarningsExact identifier
application number: M003
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edaff0ca-f305-71a4-e053-2a95a90a5dca2025-08-18WarningsExact identifier
application number: M003
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edb4a43a-5b55-3404-e053-2a95a90ada272025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - SOURBETALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9fe5a6-a729-4710-e063-6294a90a0da12025-08-18WarningsExact identifier
application number: M003
Premium Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.13d42582-df02-41d5-bada-1d67c61310152025-08-18WarningsExact identifier
application number: M003
MedPride Povidone Iodine Scrub Solution Skin CleanserPOVIDONE-IODINEShield Line LLC88dfef39-c6c2-44fc-e053-2995a90a805a2025-08-18WarningsExact identifier
application number: M003
MedPride Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEShield Line LLC88cb1b8d-3dae-be00-e053-2995a90a0d112025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - Romance GourmondALCOHOLShenzhen Lantern Scicence Co.,Ltd.3caf5726-8d4c-9d36-e063-6294a90a3cf12025-08-18WarningsExact identifier
application number: M003
Hand Sanitizer plus Serum EdenALCOHOLMoam LLC93c9f1ad-e08a-4859-bf24-db37e6b1d3082025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9c71e5-fe7a-d342-e063-6294a90a774a2025-08-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c76e629-96a0-7031-e063-6294a90a05ae2025-08-16WarningsExact 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