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 109 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethyl Rubbing Alcohol 70 PercentETHYL ALCOHOLPharma Nobis, LLCe42fccc2-1b50-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M003
Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e1-02c6-e053-2995a90a3ace2023-12-26WarningsExact identifier
application number: M003
CVS MerthiolateBENZALKONIUM CHLORIDECVS Pharmacydd498ab1-8350-41aa-86fc-2db57005f3e22023-12-22WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLCe42eee1b-3539-fb17-e053-2995a90af61d2023-12-22WarningsExact identifier
application number: M003
Decolorized IodineETHYL ALCOHOLPharma Nobis, LLCe21dd43b-3712-cb16-e053-2a95a90ac2762023-12-22WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f727c-beb0-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Pharma Nobis, LLCe42ee827-b350-7b56-e053-2a95a90a69cf2023-12-22WarningsExact identifier
application number: M003
MerthiolateBENZALKONIUM CHLORIDEPharma Nobis, LLCe42f727c-beaf-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e0-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M003
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
application number: M003
Health Mart IodidesALCOHOLStrategic Sourcing Services LLC8d9f2112-c678-4559-b567-9d6d287c5fa32023-12-20WarningsExact identifier
application number: M003
Health Mart Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLStrategic Sourcing Services LLC72eeb3e6-c0a1-4b18-87f1-8db06f9bd1112023-12-20WarningsExact identifier
application number: M003
Health Mart Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCcbe02fa1-c167-4b77-8f63-817362090e192023-12-20WarningsExact identifier
application number: M003
Health Mart Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLCfbd2aa69-b1c7-4a28-9642-a436ae09faaf2023-12-20WarningsExact identifier
application number: M003
Quality Choice Povidone IodinePOVIDONE IODINE 10%Chain Drug Market Association9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLChain Drug Market Association55c970ed-13a9-4ea2-a8cb-aaf14d3a214d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodides TinctureETHYL ALCOHOLChain Drug Market Association71aedfd5-e81f-4b69-b163-527ff1ce30b12023-12-20WarningsExact identifier
application number: M003
Quality Choice MerthiolateBENZALKONIUM CHLORIDEChain Drug Market Association5b7303b9-b8c4-4e7c-876f-70ed764430552023-12-20WarningsExact identifier
application number: M003
Premier Value Povidone IodinePOVIDONE IODINE 10%Chain Drug Consortium5cc9d782-5f7e-27d9-e053-2991aa0a24282023-12-20WarningsExact 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