FDA.reportPublic FDA data

germstar Original unscented

Product NDC
57915-004
11-digit product format
579150004
Labeler code
57915
Product ID
57915-004_29a4c097-0c59-be6d-e063-6394a90a5d76
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Soaptronic, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
Substance
ISOPROPYL ALCOHOL
Active strength
700 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
germstar Original unscented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL700 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da14d588-a9f7-4796-a532-20156afc100fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-004-01germstar Original unscented946 g in 1 BAGSOLUTION9469
57915-004-02germstar Original unscented474 g in 1 BOTTLE, PUMPSOLUTION4749
57915-004-03germstar Original unscented236 g in 1 BOTTLE, SPRAYSOLUTION2369
57915-004-04germstar Original unscented59 g in 1 BOTTLE, SPRAYSOLUTION599
57915-004-05germstar Original unscented8 g in 1 BOTTLE, SPRAYSOLUTION89

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302GERMSTAR ORIGINAL UNSCENTED (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]4
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302GERMSTAR ORIGINAL UNSCENTED (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RGERMSTAR ORIGINAL UNSCENTED (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-004GERMSTAR ORIGINAL UNSCENTED (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]9Current NDC, Legacy NDC, 5 package rows20241225_da14d588-a9f7-4796-a532-20156afc100f.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 37 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
application number: M003
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC1c051d6a-61a8-4a75-aeb6-7c1258bda2b22026-02-02Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads LargeISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.75908e89-abd9-4760-bd11-fb71133ae2c02026-02-02WarningsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads MediumISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.0cdfc6b4-7d66-4333-b38d-c465d4864b5c2026-02-02WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
application number: M003
AplicareISOPROPYL ALCOHOLAplicare Products, LLC4950e07f-36a5-b6f5-e063-6294a90a8f982026-02-02WarningsExact identifier
application number: M003
RELEEV Cold Sore TreatmentBENZALKONIUM CHLORIDEMerix Pharmaceutical Corp.fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf2026-02-02WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 91%ISOPROPYL ALCOHOLLJ Pharma07cba887-a568-4b92-91ab-2e7831f24ab52026-01-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERite Aid Corporation2f8abb6f-460f-47bf-811d-734126aa3f0b2026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLRite Aid Corporationc074bbaf-2fd7-485a-9e22-a368d8dd47012026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Drs. pharmacy triple antibiotic plus lidocaineBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENTOL PHARMA TECH, LLC49a73b0f-90d9-3a4b-e063-6294a90acfb02026-01-30WarningsExact identifier
application number: M003
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50%ISOPROPYL ALCOHOLLJ Pharma15b4a45d-3dbf-48e4-8f90-15dca7e650d92026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50% Winter GreenISOPROPYL ALCOHOLLJ Pharmafbb45bde-b733-4524-bfa9-ae819ad399732026-01-29WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDEWal-Mart Stores, Inc.f3911d79-3169-71c3-e053-2a95a90ae8432026-01-29WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEAmerifoods Trading Co38b15693-7e5f-4c85-915e-9937ea018a832026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticFIRST AID ANTISEPTICAmerisource Bergen6719db46-a6e3-4f0a-828c-fe89a51879892026-01-29Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSNda14d588-a9f7-4796-a532-20156afc100f9
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCDda14d588-a9f7-4796-a532-20156afc100f9
808520isopropyl alcohol 70 % Topical SolutionSYda14d588-a9f7-4796-a532-20156afc100f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-004-0157915000401946 g in 1 BAG (57915-004-01) 946 g2000-01-010000-00-00NoNoCurrent
57915-004-0257915000402474 g in 1 BOTTLE, PUMP (57915-004-02) 474 g2000-01-010000-00-00NoNoCurrent
57915-004-0357915000403236 g in 1 BOTTLE, SPRAY (57915-004-03) 236 g2000-01-010000-00-00NoNoCurrent
57915-004-045791500040459 g in 1 BOTTLE, SPRAY (57915-004-04) 59 g2000-01-010000-00-00NoNoCurrent
57915-004-05579150004058 g in 1 BOTTLE, SPRAY (57915-004-05) 8 g2000-01-010000-00-00NoNoCurrent