germstarONE

Product NDC
57915-020
Requested package NDC
57915-020-01
11-digit product format
579150020
Labeler code
57915
Product ID
57915-020_29a4cfde-1821-e664-e063-6394a90a9d87
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57915-02057915-020-01DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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
a6909a0f-de15-51e3-e053-2995a90ab34fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-020-01germstarONE946 g in 1 BAGSOLUTION94617
57915-020-02germstarONE474 g in 1 BOTTLE, PUMPSOLUTION47417
57915-020-04germstarONE59 g in 1 BOTTLE, SPRAYSOLUTION5917
57915-020-05germstarONE3785 g in 1 BOTTLESOLUTION378517

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MGERMSTARNORO (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]6
ALCOHOLACTIVE MOIETY3K9958V90MGERMSTARNORO (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RGERMSTARNORO (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-020GERMSTARONE (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]17Current NDC, Legacy NDC, 4 package rows20241225_a6909a0f-de15-51e3-e053-2995a90ab34f.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 96 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DK12 Shower Gel Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e4ff0e-ef63-ef3b-e063-6294a90aa2b82024-12-02WarningsExact identifier
application number: M003
DK12 Vitamin E Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe9270c0-bf6b-f0ff-e053-6394a90ae8f12024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2e51b-212b-368e-e063-6294a90a871c2024-12-02WarningsExact identifier
application number: M003
DK12 Fresh Energy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe80635d-9594-abf3-e053-6394a90aa78b2024-12-02WarningsExact identifier
application number: M003
DK12 Shower Gel CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e36111-ed4e-12de-e063-6294a90af6392024-12-02WarningsExact identifier
application number: M003
DK12 Creamy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe7fde7e-82fc-c13f-e053-6394a90aff682024-12-02WarningsExact identifier
application number: M003
DK12 Oatmeal Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe16387b-1b16-1f41-e053-6294a90ae2c02024-12-02WarningsExact identifier
application number: M003
First Aid Antiseptic Isopropyl Alcohol PadISOPROPYL ALCOHOLFourstar Group USA, Inc.27edf5dc-3e68-bdd0-e063-6394a90ac4852024-11-27WarningsExact identifier
application number: M003
MicroKlenz AntimicrobialBENZETHONIUM CHLORIDEMedline Industries, LP115dda08-709c-490a-9693-419b514419602024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadALCOHOL PADAcme United Corporation55421010-d806-4ca4-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M003
First Aid Only Hydrogen Peroxide 3%HYDROGEN PEROXIDEAcme United Corporationnf1db8929-9b95-0d6e-e053-2995a90a817f2024-11-26WarningsExact identifier
application number: M003
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
application number: M003
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
application number: M003
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
application number: M003
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041807alcohol 63 % Topical SolutionPSNa6909a0f-de15-51e3-e053-2995a90ab34f17
1041807ethanol 0.63 ML/ML Topical SolutionSCDa6909a0f-de15-51e3-e053-2995a90ab34f17
1041807ethanol 63 % Topical SolutionSYa6909a0f-de15-51e3-e053-2995a90ab34f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-020-0157915002001946 g in 1 BAG (57915-020-01) 946 g2020-05-120000-00-00NoNoCurrent