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	2026-10-15
excluded package	package	57915-020	57915-020-01	D	Discontinued by firm	2026-10-15
excluded package	package	57915-020	57915-020-02	D	Discontinued by firm	2026-10-15
excluded package	package	57915-020	57915-020-04	D	Discontinued by firm	2026-10-15

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 93 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RUBBING ALCOHOL	ALCOHOL	INTERNATIONAL GENERAL TRADING CORP	bd5ee961-1d64-0d9d-e053-2a95a90a6010	2024-12-18	Warnings	Exact identifier application number: M003
70% Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	SZY Holdings, LLC dba EverReady First Aid	1e39b0f4-66d1-47ac-aed6-d6ac019888ce	2024-12-18	Warnings	Exact identifier application number: M003
RUBBING ALCOHOL	ALCOHOL	INTERNATIONAL GENERAL TRADING CORP	bd5eb0df-cd2d-691c-e053-2995a90a2511	2024-12-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	First Aid Research Corp.	7d1c0382-31b3-48d0-a514-c5cc45a2299e	2024-12-18	Warnings	Exact identifier application number: M003
First Aid Only First Aid-Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Acme United Corporation	f31a44ff-e4ac-de1e-e053-2a95a90ab036	2024-12-18	Warnings	Exact identifier application number: M003
Hand Sanitizer (Lavender Rosemary)	HAND SANITIZER SPRAY	Tubby Todd	2992a52a-21a9-18be-e063-6294a90a834d	2024-12-18	Warnings	Exact identifier application number: M003
CVS Decolorized Iodine	ALCOHOL	CVS Pharmacy	d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd	2024-12-18	Warnings	Exact identifier application number: M003
De La Cruz Decolorized Iodine	ETHYL ALCOHOL	DLC Laboratories, Inc.	5d8f6aaa-0b87-1166-e053-2991aa0a297f	2024-12-18	Warnings	Exact identifier application number: M003
Humco Povidone Iodine	POVIDONE IODINE 10%	Humco Holding Group, Inc.	1e078022-f32c-48bd-8add-f83aebcc5812	2024-12-18	Warnings	Exact identifier application number: M003
Univ of Vermont Medical Center Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7841cfa9-e94e-4c3d-b5fb-676924017845	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital Mothers Vaginal	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7f1a85fd-086b-4fc7-abac-863dd3ea505a	2024-12-17	Warnings	Exact identifier application number: M003
Mary Kay Satin Hands Shea Hand Sanitizer	ALCOHOL	Mary Kay Inc.	b6c2b979-2940-1569-e053-2995a90a532c	2024-12-17	Warnings	Exact identifier application number: M003
Foster and Thrive Decolorized Iodine	ALCOHOL LIQUID	Strategic Sourcing Services, LLC	2981529a-2bd0-3e9e-e063-6294a90a7236	2024-12-17	Warnings	Exact identifier application number: M003
Foster and Thrive 2% Mild Iodine Tincture	IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID	Strategic Sourcing Services, LLC	2981cb97-17de-ebda-e063-6394a90ad281	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital H.E.A.R.T. Strings Tote	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	f8369a27-1995-4fdd-a282-35c344c11d83	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital Amenity Kit	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	877ce875-c5b0-4d9b-8f00-682914e3bc0e	2024-12-17	Warnings	Exact identifier application number: M003
Wellstar Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	ced9dd96-7922-43d7-906f-32afaad733ec	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital C-Section Mothers	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	9df6d0e9-631c-4619-9d96-d2c5a32a590e	2024-12-17	Warnings	Exact identifier application number: M003
Memorial Sloan Kettering Cancer Center Amenity Kit	SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	cab0bef1-f486-4eac-a61b-6030467d8650	2024-12-17	Warnings	Exact identifier application number: M003
Sarasota Memorial Amenity	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	f5dda019-fcfd-4e99-89cc-e79e76b402e7	2024-12-17	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