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 41 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
application number: M003
BIOPURE Hand Sanitizer Spray-Coastal GlowHAND SANITIZER SPRAYQuest USA Corp48254577-9f1e-9389-e063-6394a90a92f12026-01-15WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487a4c8e-4fb3-6bff-e063-6294a90abd532026-01-15WarningsExact identifier
application number: M003
Gold Bond Hydrating Hand SanitizerETHYL ALCOHOLChattem, Inc.96fe0191-0d34-4bf3-8f93-0e64764c353a2026-01-14WarningsExact identifier
application number: M003
Alcohol Prep AwabsISOPROPYL ALCOHOLEnlightening Pallet Industry Co., Limited26c7db1e-86a9-8765-e063-6294a90a634f2026-01-14WarningsExact identifier
application number: M003
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDealMed Medical Supplies LLC04e6edb5-07ef-4ed4-ba68-ed183386b5ab2026-01-13WarningsExact identifier
application number: M003
Dermoplast First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLCec93011d-7069-4021-8dd2-3d51eb6026e12026-01-13WarningsExact identifier
application number: M003
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 32ozWISH RUBBING ALCOHOL 32OZ 70%CLICK PRODUCTS LLC4836b564-0b8c-2fb4-e063-6394a90a9c4a2026-01-13WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDealMed Medical Supplies LLC6d1ddf10-8873-4781-9165-bb1c4bbccfc92026-01-13WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHydrox Laboratories6e5709b4-cc56-4768-b704-1d9b0e3efec72026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact 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