FDA.reportPublic FDA data

germstarCitrus

Product NDC
57915-005
Requested package NDC
57915-005-04
11-digit product format
579150005
Labeler code
57915
Product ID
57915-005_29a5c75a-da7e-385f-e063-6394a90a1416
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
2000-01-01
Substance
ALCOHOL
Active strength
630 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
germstarCitrus
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
779abef7-53ff-47c3-b7e6-27570eb055b3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-005-01germstarCitrus946 g in 1 BAGSOLUTION94612
57915-005-02germstarCitrus474 g in 1 BOTTLE, PUMPSOLUTION47412
57915-005-03germstarCitrus236 g in 1 BOTTLE, SPRAYSOLUTION23612
57915-005-04germstarCitrus59 g in 1 BOTTLE, SPRAYSOLUTION5912
57915-005-05germstarCitrus8 g in 1 BOTTLE, SPRAYSOLUTION812
57915-005-07germstarCitrus355 g in 1 BAGSOLUTION35512

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MGERMSTARCITRUS (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]4
ALCOHOLACTIVE MOIETY3K9958V90MGERMSTARCITRUS (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RGERMSTARCITRUS (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-005GERMSTARCITRUS (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]12Current NDC, Legacy NDC, 6 package rows20241225_779abef7-53ff-47c3-b7e6-27570eb055b3.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 81 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
application number: M003
Northside Hospital Grey Amenity KitSODIUM MONOFLUOROPHOSPATEASP Global, LLCa3cc89df-be1b-4d9a-8ba3-8578853254222025-04-09WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
application number: M003
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
application number: M003
mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.322b90e8-be38-7237-e063-6394a90a488f2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c0bdd-4dc5-52e7-e063-6294a90a13802025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c56b0-7eb6-c33a-e063-6394a90a15fb2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.322ce179-c528-0f62-e063-6394a90ac5602025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticHYDROGEN PEROXIDEUltra Distributors Incb6f7b346-3d6b-5953-e053-2995a90a878f2025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
application number: M003
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
application number: M003
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
application number: M003
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
application number: M003
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
application number: M003
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
application number: M003
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
application number: M003
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
application number: M003
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
application number: M003
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041807alcohol 63 % Topical SolutionPSN779abef7-53ff-47c3-b7e6-27570eb055b312
1041807ethanol 0.63 ML/ML Topical SolutionSCD779abef7-53ff-47c3-b7e6-27570eb055b312
1041807ethanol 63 % Topical SolutionSY779abef7-53ff-47c3-b7e6-27570eb055b312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57915-005-045791500050459 g in 1 BOTTLE, SPRAY (57915-005-04) 59 g2000-01-010000-00-00NoNoCurrent