FDA.reportPublic FDA data

Germstar Premium Hand Sanitizer

Product NDC
57915-008
11-digit product format
579150008
Labeler code
57915
Product ID
57915-008_2c7baede-035b-8ba4-e063-6294a90a4a7d
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
2017-03-01
Substance
ALCOHOL
Active strength
630 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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-008-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-008-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-008-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-008-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57915-008-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-008-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-008-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-008-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-008-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57915-008-050efc9e666f02…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
Germstar Premium Hand Sanitizer
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
489652af-7333-628a-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-008-01Germstar Premium Hand Sanitizer59 g in 1 BOTTLE, SPRAYSOLUTION594
57915-008-02Germstar Premium Hand Sanitizer59 g in 1 BOTTLE, SPRAYSOLUTION594
57915-008-03Germstar Premium Hand Sanitizer59 g in 1 BOTTLE, SPRAYSOLUTION594
57915-008-04Germstar Premium Hand Sanitizer59 g in 1 BOTTLE, SPRAYSOLUTION594
57915-008-05Germstar Premium Hand Sanitizer59 g in 1 BOTTLE, SPRAYSOLUTION594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-008GERMSTAR PREMIUM HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC LLC]4Current NDC, Legacy NDC, 5 package rows20250126_489652af-7333-628a-e054-00144ff8d46c.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 50 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0ef369-a0e7-5320-e063-6394a90a353f2025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC45c3c6da-5217-5c2b-e063-6294a90a56d32025-12-12WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZERALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd1abf5aca-346f-0d18-e063-6294a90a93392025-12-11WarningsExact identifier
application number: M003
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
application number: M003
DEYODISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.b147ed5b-ab6e-ca00-e053-2a95a90ae01a2025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC1ea56ac9-4fc2-41c0-adda-5a2c55bef6962025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC847b9edc-74e6-43fd-83cd-43e6712780c62025-12-10WarningsExact identifier
application number: M003
The Pharma-C Company 70 Isopropyl Alcohol PadsISOPROPYL ALCOHOLKleen Test Products Corporationc5df867b-1b8d-4e38-8c32-7d528b9825902025-12-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041807alcohol 63 % Topical SolutionPSN489652af-7333-628a-e054-00144ff8d46c4
1041807ethanol 0.63 ML/ML Topical SolutionSCD489652af-7333-628a-e054-00144ff8d46c4
1041807ethanol 63 % Topical SolutionSY489652af-7333-628a-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-008-015791500080159 g in 1 BOTTLE, SPRAY (57915-008-01) 59 g2017-03-010000-00-00NoNoCurrent
57915-008-025791500080259 g in 1 BOTTLE, SPRAY (57915-008-02) 59 g2017-03-010000-00-00NoNoCurrent
57915-008-035791500080359 g in 1 BOTTLE, SPRAY (57915-008-03) 59 g2017-03-010000-00-00NoNoCurrent
57915-008-045791500080459 g in 1 BOTTLE, SPRAY (57915-008-04) 59 g2017-03-010000-00-00NoNoCurrent
57915-008-055791500080559 g in 1 BOTTLE, SPRAY (57915-008-05) 59 g2017-03-010000-00-00NoNoCurrent