FDA.reportPublic FDA data

germstarLuxe

Product NDC
57915-007
11-digit product format
579150007
Labeler code
57915
Product ID
57915-007_2cd1af31-de7d-d32b-e063-6294a90a430b
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
2017-02-01
Substance
ALCOHOL
Active strength
630 g/1000g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-17ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-19ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-007-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-170efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-190efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-007-110efc9e666f02…f202fb6c5f17…

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
germstarLuxe
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
471b466f-e3e5-3601-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-007-01germstarLuxe8 g in 1 BOTTLE, SPRAYSOLUTION87
57915-007-02germstarLuxe8 g in 1 BOTTLE, SPRAYSOLUTION87
57915-007-03germstarLuxe8 g in 1 BOTTLE, SPRAYSOLUTION87
57915-007-10germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-11germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-12germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-13germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-14germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-15germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-16germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-17germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-18germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-19germstarLuxe118 g in 1 BOTTLESOLUTION1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-007GERMSTARLUXE (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]7Current NDC, Legacy NDC, 13 package rows20250130_471b466f-e3e5-3601-e054-00144ff88e88.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 80 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spicy CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b8e946-b52b-fa2e-e063-6294a90ae1a72025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b920b7-91b4-52df-e063-6394a90a745e2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitize MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b95351-5115-7200-e063-6394a90a58402025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Antiseptic WipeBENZALKONIUM CHLORIDETotal Resources International, Incf2151af3-d76a-490f-90ff-728c350fe1682025-04-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041807alcohol 63 % Topical SolutionPSN471b466f-e3e5-3601-e054-00144ff88e887
1041807ethanol 0.63 ML/ML Topical SolutionSCD471b466f-e3e5-3601-e054-00144ff88e887
1041807ethanol 63 % Topical SolutionSY471b466f-e3e5-3601-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-007-01579150007018 g in 1 BOTTLE, SPRAY (57915-007-01) 8 g2017-02-010000-00-00NoNoCurrent
57915-007-02579150007028 g in 1 BOTTLE, SPRAY (57915-007-02) 8 g2017-02-010000-00-00NoNoCurrent
57915-007-03579150007038 g in 1 BOTTLE, SPRAY (57915-007-03) 8 g2017-02-010000-00-00NoNoCurrent
57915-007-105791500071015 g in 1 BOTTLE, SPRAY (57915-007-10) 15 g2019-02-010000-00-00NoNoCurrent
57915-007-115791500071115 g in 1 BOTTLE, SPRAY (57915-007-11) 15 g2019-02-010000-00-00NoNoCurrent
57915-007-125791500071215 g in 1 BOTTLE, SPRAY (57915-007-12) 15 g2019-02-010000-00-00NoNoCurrent
57915-007-135791500071315 g in 1 BOTTLE, SPRAY (57915-007-13) 15 g2019-02-010000-00-00NoNoCurrent
57915-007-145791500071415 g in 1 BOTTLE, SPRAY (57915-007-14) 15 g2019-02-010000-00-00NoNoCurrent
57915-007-1557915000715118 g in 1 BOTTLE (57915-007-15) 118 g2019-02-010000-00-00NoNoCurrent
57915-007-1657915000716118 g in 1 BOTTLE (57915-007-16) 118 g2019-02-010000-00-00NoNoCurrent
57915-007-1757915000717118 g in 1 BOTTLE (57915-007-17) 118 g2019-02-010000-00-00NoNoCurrent
57915-007-1857915000718118 g in 1 BOTTLE (57915-007-18) 118 g2019-02-010000-00-00NoNoCurrent
57915-007-1957915000719118 g in 1 BOTTLE (57915-007-19) 118 g2019-02-010000-00-00NoNoCurrent