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 51 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
application number: M003
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
application number: M003
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
application number: M003
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
application number: M003
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
application number: M003
Antibacterial WipesBENZALKONIUM CHLORIDEERC Acquisition, Incdc6c39af-447c-481a-98b5-33b8f09b83bc2025-12-05WarningsExact identifier
application number: M003
Sanitex Antibacterial Hand Wipes Fresh ScentBENZALKONIUM CHLORIDEPrecare Corp48907146-ca66-46e1-928b-a8f968a6bff82025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIBACTERIAL WIPESAvro Enterprises LLCcf42e470-19c8-2e11-e053-2995a90ae90d2025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIMICROBIAL WIPESAvro Enterprises LLCcf4680f4-24b2-1242-e053-2a95a90a93742025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESTarget Corporationf6037707-c6bb-11a0-e053-2995a90acce82025-12-05WarningsExact identifier
application number: M003
Sanitizing WipesBENZALKONIUM CHLORIDEZogics, LLC2cd916ee-dc6d-49e4-a9b5-06ad4b2b054d2025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf28c2c1e-7d0a-45b9-e053-2995a90a47102025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX ICE MINT AND EUCALYPTUS MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf2a107aa-5ad3-7bad-e053-2a95a90a1d972025-12-05WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE SWABSTICKPOVIDONE-IODINEClick Industries LLC974e1205-01ab-4599-9229-cdf5225d268a2025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
application number: M003
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERDynarex Corporation450e56f0-b8ae-072a-e063-6394a90a2d4b2025-12-03WarningsExact 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