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 34 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDETopco Associates LLCc3509fd3-e1bc-42bd-881e-7fb520ace9f92026-02-13WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalgreen Co.b1c71ff1-8ffa-46df-9b43-86ed062c3a982026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
IodineIODINEWalgreen Co.d3d44c9f-4eb6-4e5b-9943-c0f80f06952d2026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalgreen Co.eea239fe-554f-4487-9312-3ab0af27d5302026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Consortium, LLCd7154398-4f52-434a-b51b-b7829ccebf3b2026-02-12WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP26e10080-d389-4994-e054-00144ff8d46c2026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LPd980969d-694b-4c9e-a931-73beaceb51da2026-02-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
application number: M003
Hydrogen Peroxide First Aid AntisepticHYDROGEN PEROXIDEMedline Industries, LP4593f51a-9bcb-4149-9ce4-4f62183fd3dd2026-02-11WarningsExact identifier
application number: M003
Hydrogen peroxideHYDROGEN PEROXIDEMedline Industries, LP26a67a91-ee2d-6a6c-e054-00144ff88e882026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCbe4f41bd-8a75-4fb6-8d28-67f6f853e6bd2026-02-11Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLTopco Associates LLC9fbded5f-8dc1-4134-a711-48d1a581d8742026-02-11Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCad1ef2ea-bfc3-4a8a-acd2-55e7f52813d42026-02-11Warnings, Adverse reactionsExact identifier
application number: M003
Antibacterial Wet wipesBENZALKONIUM CHLORIDEZhejiang Easyclean Daily Chemical Co., Ltd.a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf2026-02-11WarningsExact identifier
application number: M003
Universal ISOPROPYL Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC0c76f14b-9a0c-4573-96f2-cd4080eb99e62026-02-10WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLWalgreen Co.a08ef11f-5c4f-4821-a0c0-d6c89def0bea2026-02-10Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLWalgreen Co.fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc2026-02-10Warnings, Adverse reactionsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.49e31509-d489-44be-e063-6394a90a97ef2026-02-10WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VMY IMPORTS USA LLC4a849c4f-9b96-6b20-e063-6394a90a34862026-02-10WarningsExact 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