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 58 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health5459a0b4-65ca-455e-80b2-3fe1b24e01372025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPhoenix Healthcare Solutions LLCc68d2d73-be78-8e1c-e053-2995a90a3a372025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa7d77afc-588d-47d7-be2f-686ff3d75da22025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCca9f8e68-cc15-42b4-81fd-e114e6a6d7df2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC50b24287-4c91-43d2-9c2e-42d3c086b3b32025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC51b707c6-df09-441b-a3d1-3f0c1b0886cc2025-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep SwabstickPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLC8a0aba34-3f96-46b6-8521-f4388fb73edf2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
application number: M003
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact 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