FDA.reportPublic FDA data

GERMSTARORIGINAL

Product NDC
57915-001
Requested package NDC
57915-001-01
11-digit product format
579150001
Labeler code
57915
Product ID
57915-001_2c797d11-a351-c63d-e063-6394a90a9376
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-00157915-001-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-00157915-001-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
GERMSTARORIGINAL
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
da3ac935-7dc7-4100-a702-959eb84077b2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-001-01GERMSTARORIGINAL946 g in 1 BAGSOLUTION94627
57915-001-02GERMSTARORIGINAL474 g in 1 BOTTLE, PUMPSOLUTION47427
57915-001-03GERMSTARORIGINAL236 g in 1 BOTTLE, SPRAYSOLUTION23627
57915-001-04GERMSTARORIGINAL59 g in 1 BOTTLE, SPRAYSOLUTION5927
57915-001-05GERMSTARORIGINAL8 g in 1 BOTTLE, SPRAYSOLUTION827
57915-001-06GERMSTARORIGINAL3780 g in 1 BOTTLESOLUTION378027

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302GERMSTARORIGINAL (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]19
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302GERMSTARORIGINAL (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]19
WATERINACTIVE INGREDIENT059QF0KO0RGERMSTARORIGINAL (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-001GERMSTARORIGINAL (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]27Current NDC, Legacy NDC, 6 package rows20250126_da3ac935-7dc7-4100-a702-959eb84077b2.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 42 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scented Hand SanitizerSCENTED HAND SANITIZERBeacon Promotions, Inc.1f95444c-7587-a07e-e063-6394a90af5342026-01-12WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.6d472aef-0d95-4c21-a373-bd16bc7b63ed2026-01-12WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.3cce065a-0254-43ad-a96f-aae6979997be2026-01-12WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.b58145c6-0f6c-5a47-e053-2995a90a5d7f2026-01-09WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Inc.b5815ca2-edaa-bc8c-e053-2a95a90a3df22026-01-09WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLJC SALES1f3466d2-6a2e-f871-e063-6394a90af0852026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products1e2cb45c-7e70-01dd-e063-6294a90aa16b2026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products063a1e99-dda6-9cb9-e063-6294a90aa1b32026-01-09WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.04ac8597-00fa-458f-a929-ada5042a8c382026-01-09WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMXCHLOROXYLENOLXinxiang Xinda Technology Co.,Ltd125b3c3b-0a3a-9fd3-e063-6394a90a135a2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd125a49c3-15c0-fbad-e063-6394a90a5d2e2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHGCHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd125ac9df-03db-83e9-e063-6394a90afeab2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSNda3ac935-7dc7-4100-a702-959eb84077b227
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCDda3ac935-7dc7-4100-a702-959eb84077b227
808520isopropyl alcohol 70 % Topical SolutionSYda3ac935-7dc7-4100-a702-959eb84077b227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-001-0157915000101946 g in 1 BAG (57915-001-01) 946 g2000-01-010000-00-00NoNoCurrent