germstarONE

Product NDC: 57915-020
Requested package NDC: 57915-020-01
11-digit product format: 579150020
Labeler code: 57915
Product ID: 57915-020_29a4cfde-1821-e664-e063-6394a90a9d87
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: 2020-04-30
Substance: ALCOHOL
Active strength: 630 g/1000g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57915-020	57915-020-01	D	Discontinued by firm		2026-10-21

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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: germstarONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	630 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1041807	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6909a0f-de15-51e3-e053-2995a90ab34f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57915-020-01	germstarONE	946 g in 1 BAG	SOLUTION	946	17
57915-020-02	germstarONE	474 g in 1 BOTTLE, PUMP	SOLUTION	474	17
57915-020-04	germstarONE	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	17
57915-020-05	germstarONE	3785 g in 1 BOTTLE	SOLUTION	3785	17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	GERMSTARNORO (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]	6
ALCOHOL	ACTIVE MOIETY	3K9958V90M	GERMSTARNORO (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	GERMSTARNORO (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57915-020	GERMSTARONE (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]	17	Current NDC, Legacy NDC, 4 package rows	20241225_a6909a0f-de15-51e3-e053-2995a90ab34f.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 95 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OPS RANCH HAND ANTIBACTERIAL FOAMING	CHLOROXYLENOL	Archer Manufacturing, Inc.	d8187090-8423-062e-e053-2a95a90aad18	2024-12-05	Warnings	Exact identifier application number: M003
BLACK OPS AB ANTIBACTERIAL FOAMING	BENZALKONIUM CHLORIDE	Archer Manufacturing, Inc.	d335bf6d-dc75-bd80-e053-2a95a90abb56	2024-12-05	Warnings	Exact identifier application number: M003
OPS INSTANT HAND SANITIZER	BENZALKONIUM CHLORIDE	Archer Manufacturing, Inc.	d4c65a93-832a-6a8b-e053-2a95a90a77b8	2024-12-05	Warnings	Exact identifier application number: M003
alcohol pad 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	03a6e8d4-535d-b316-e063-6294a90aebf5	2024-12-04	Warnings	Exact identifier application number: M003
antiseptic towelette 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f2a1f1-ceb6-2f20-e053-2a95a90a18db	2024-12-04	Warnings	Exact identifier application number: M003
BobBarker antibacterial wrapped body	BENZETHONIUM CHLORIDE	Yangzhou H&R Plastic Daily Chemical Co., Ltd.	208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa5	2024-12-04	Warnings	Exact identifier application number: M003
Walgreens 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walgreen Co.	21f125a0-73e8-34a9-e063-6294a90a8396	2024-12-04	Warnings	Exact identifier application number: M003
Emory Johns Creek Amenity	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global	952ccb85-71bb-4d5d-ac9b-62851a39d36d	2024-12-04	Warnings	Exact identifier application number: M003
Watermelon Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1f0f9885-2ad5-09de-e063-6394a90ad0d7	2024-12-03	Warnings	Exact identifier application number: M003
Foster and Thrive Povidone-Iodine	POVIDONE IODINE	Strategic Sourcing Services, LLC	28621f29-ce45-c6dc-e063-6294a90aa5f7	2024-12-03	Warnings	Exact identifier application number: M003
Sanitizing Hand Mist Unscented	ETHYL ALCOHOL	ALO New York LLC	e194daee-2197-4718-e053-2a95a90a4890	2024-12-03	Warnings	Exact identifier application number: M003
Instant Hand Antiseptic	ALCOHOL	ASP Global	291eaa18-81f8-6907-e054-00144ff88e88	2024-12-03	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Passion Berrys	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	aee5d7c2-93b3-f55e-e053-2995a90af72e	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Fresh and Relax	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d3086-7902-2837-e053-2995a90a39df	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Grapefruit	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f49-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Red Fruits	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f4d-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Oatmeal	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e1c5f6-195c-16d6-e063-6394a90abb86	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Instant Hand Sanitizer	ETHYL ALCOHOL 70%	Industria La Popular, S.A.	b2e4d58d-adff-3cb2-e053-2995a90a392e	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2289d-60f4-260c-e063-6394a90a96f6	2024-12-02	Warnings	Exact identifier application number: M003
Jabonito Kids Green Apple Liquid	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	021bc525-3ebe-efc2-e063-6394a90a3fe3	2024-12-02	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1041807	alcohol 63 % Topical Solution	PSN	a6909a0f-de15-51e3-e053-2995a90ab34f	17
1041807	ethanol 0.63 ML/ML Topical Solution	SCD	a6909a0f-de15-51e3-e053-2995a90ab34f	17
1041807	ethanol 63 % Topical Solution	SY	a6909a0f-de15-51e3-e053-2995a90ab34f	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57915-020-01	57915002001	946 g in 1 BAG (57915-020-01)	946 g	2020-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
germstarONE	Soaptronic, LLC	2024-12-19	HUMAN OTC DRUG LABEL	17
germstarONE	Soaptronic, LLC	2020-05-12	HUMAN OTC DRUG LABEL	11