germstarONE

Product NDC: 57915-020
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57915-020		D	Discontinued by firm	2026-10-12
excluded package	package	57915-020	57915-020-01	D	Discontinued by firm	2026-10-12
excluded package	package	57915-020	57915-020-02	D	Discontinued by firm	2026-10-12
excluded package	package	57915-020	57915-020-04	D	Discontinued by firm	2026-10-12

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57915-020-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57915-020-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57915-020-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57915-020-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57915-020-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57915-020-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57915-020-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57915-020-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57915-020-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57915-020-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57915-020-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57915-020-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57915-020-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57915-020-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57915-020-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57915-020-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57915-020-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57915-020-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57915-020-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57915-020-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57915-020-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-020-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-020-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-020-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-020-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-020-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-020-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57915-020-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57915-020-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57915-020-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57915-020-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57915-020-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57915-020-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57915-020-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57915-020-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57915-020-01	`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 38 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Big Lots Stores, Inc.	2c941c08-929c-43c9-966b-279086afca96	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Big Lots Stores, Inc.	2ef87a8a-58be-4123-ad03-9891e6916f1a	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Cardinal Health, 110 dba Leader	d1418649-9490-4dab-b89c-9de6bb719642	2026-01-29	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Cardinal Health, 110 dba Leader	c56cbcbf-8e0e-4dff-80d3-df420c500a93	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cariba International	001c1fcf-2808-467c-86d8-c038513fa3b5	2026-01-29	Warnings	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Cariba International	483586f4-aab4-40c2-8925-c4f7fb22c6aa	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Cariba International	2c48f58a-a2d1-4a28-8dbf-a9d2c620bca6	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
New Skin Bandage	BENZETHONIUM CHLORIDE	Advantice Health, LLC	60996119-8367-4e22-b6ec-c36490635fa4	2026-01-28	Warnings	Exact identifier application number: M003
BZK Pads	BENZALKONIUM CHLORIDE	Dynarex Corporation	1409c437-ff17-481d-94be-87dd6d463ba9	2026-01-28	Warnings	Exact identifier application number: M003
Singular Wipes Unscented	ISOPROPYL ALCOHOL	SINGULAR ENTERPRISES LLC	ac2b352f-6cb2-4683-bb41-13e8ecb186bf	2026-01-27	Warnings	Exact identifier application number: M003
Singular Wipes fresh Citrus Scent	ALCOHOL	SINGULAR ENTERPRISES LLC	867a25d2-3d2c-4dad-bbe8-84195c03a87d	2026-01-27	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4906f079-8c9f-e3b0-e063-6294a90ad0f8	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4912b681-e21a-1ddf-e063-6294a90aa9f4	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491a6d77-8a84-c76d-e063-6394a90ac61f	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491b55ca-2c7a-0eb7-e063-6394a90a9cb7	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491c4af8-c699-7128-e063-6294a90ae0f9	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491de8ca-07e7-0aa3-e063-6394a90ae36f	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	492793db-7dc2-8313-e063-6394a90a52bf	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4928615e-d1a9-72b8-e063-6394a90aa7ed	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4943e51a-bb8e-745a-e063-6294a90a0a3d	2026-01-26	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
57915-020-02	57915002002	474 g in 1 BOTTLE, PUMP (57915-020-02)	474 g	2020-04-30	0000-00-00	No	No	Current
57915-020-04	57915002004	59 g in 1 BOTTLE, SPRAY (57915-020-04)	59 g	2020-05-12	0000-00-00	No	No	Current
57915-020-05	57915002005	3785 g in 1 BOTTLE (57915-020-05)	3785 g	2020-05-12	0000-00-00	No	No	Current
57915-020-07	57915002007	355 g in 1 BAG (57915-020-07)	355 g	2020-04-30	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