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 47 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.479beac0-16bc-a88c-e063-6394a90a42f52026-01-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Silicone Case 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.478b0ba2-d8ce-8101-e063-6294a90a64642026-01-03WarningsExact identifier
application number: M003
CASA COLADA SAPRY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47679265-2ec3-4c62-e063-6294a90a60b62026-01-02WarningsExact identifier
application number: M003
Fiji Punch Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4767ed4b-ebec-ca75-e063-6294a90a82d32026-01-02WarningsExact identifier
application number: M003
VILLA VANILLA HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47682ec1-5479-2ea5-e063-6394a90aa1922026-01-02WarningsExact identifier
application number: M003
Wipex Sanitizing WipesBENZALKONIUM CHLORIDEUnico476d7085-82d8-5e84-e063-6394a90a64482026-01-02WarningsExact identifier
application number: M003
Alcohol PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.74dc43d1-2aba-4f8a-876a-ce712ad37eeb2026-01-01WarningsExact identifier
application number: M003
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
application number: M003
Iodine Prep Pad AntisepticPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.0fdded64-4e89-d28c-e063-6394a90a7b8f2026-01-01WarningsExact identifier
application number: M003
OP First Aid Series Alcohol Prep PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4555-358e-e053-2995a90ae0ff2026-01-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAstera International LLCa5189240-19ce-7715-e053-2995a90ad0432025-12-31WarningsExact identifier
application number: M003
Water Jel Hydrogen PeroxideHYDROGEN PEROXIDEWater-Jel Technologiesf508c3cb-e162-4d11-9513-ff44918f82c02025-12-31WarningsExact identifier
application number: M003
HEB 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLHEB Grocery Companye8dd7f84-3690-4ab3-a21f-43bf66984f4b2025-12-30WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
application number: M003
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
application number: M003
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
application number: M003
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact 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