germstarONE

Product NDC
57915-020
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57915-020DDiscontinued by firm2026-10-05
excluded packagepackage57915-02057915-020-01DDiscontinued by firm2026-10-05
excluded packagepackage57915-02057915-020-02DDiscontinued by firm2026-10-05
excluded packagepackage57915-02057915-020-04DDiscontinued by firm2026-10-05

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57915-020-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57915-020-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57915-020-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57915-020-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57915-020-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57915-020-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57915-020-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57915-020-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57915-020-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57915-020-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57915-020-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57915-020-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57915-020-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57915-020-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57915-020-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57915-020-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57915-020-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57915-020-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57915-020-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57915-020-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57915-020-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-020-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-020-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-020-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-020-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-020-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-020-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57915-020-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57915-020-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57915-020-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57915-020-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57915-020-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57915-020-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57915-020-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57915-020-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57915-020-01557ba5c1ecfa…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 9 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AEROAIDBENZALKONIUM CHLORIDEAero Healthcare US LLCc9d55d86-0a4e-4c44-96e8-8d13fd16c54d2026-07-24WarningsExact identifier
application number: M003
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd9c9bfc61-9504-4362-8bdb-c15aa66f5a062026-07-23WarningsExact identifier
application number: M003
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltdd4d5cb95-5ee5-4006-b368-f3244fc9cd6c2026-07-23WarningsExact identifier
application number: M003
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd8f10a193-7e01-40df-b62a-73fff5b830e32026-07-23WarningsExact identifier
application number: M003
MISTIFY WATERMELON HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bf021-6352-e3fc-e063-6394a90ad6de2026-07-23WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINE 5%Walgreen Company262ea2c8-f571-1c0b-e063-6394a90af20b2026-07-22WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
application number: M003
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
application number: M003
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
application number: M003
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
application number: M003
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsExact identifier
application number: M003
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
application number: M003
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
application number: M003
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
application number: M003
Midnight Magic Hand SanitizerALCOHOLScent Theory Products LLC5721d186-ec6d-fa26-e063-6294a90a76d22026-07-21WarningsExact identifier
application number: M003
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsExact identifier
application number: M003
Twisted Caramel Apple Hand SanitizerALCOHOLScent Theory Products LLC572a82e3-93ec-9af4-e063-6294a90a9c262026-07-21WarningsExact identifier
application number: M003
Molten Marshmallow Hand SanitizerALCOHOLScent Theory Products LLC572aa67e-52f7-b424-e063-6394a90ac4ae2026-07-21WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact 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
57915-020-0257915002002474 g in 1 BOTTLE, PUMP (57915-020-02) 474 g2020-04-300000-00-00NoNoCurrent
57915-020-045791500200459 g in 1 BOTTLE, SPRAY (57915-020-04) 59 g2020-05-120000-00-00NoNoCurrent
57915-020-05579150020053785 g in 1 BOTTLE (57915-020-05) 3785 g2020-05-120000-00-00NoNoCurrent
57915-020-0757915002007355 g in 1 BAG (57915-020-07) 355 g2020-04-300000-00-00NoNoCurrent