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	2026-10-16
excluded package	package	57915-020	57915-020-01	D	Discontinued by firm	2026-10-16
excluded package	package	57915-020	57915-020-02	D	Discontinued by firm	2026-10-16
excluded package	package	57915-020	57915-020-04	D	Discontinued by firm	2026-10-16

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 111 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaWound Wound Care	POVIDONE-IODINE	Progressive Doctors, LLC	2d49daa7-aa02-4219-880b-e1697bde8a7e	2023-12-15	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ALCOHOL	Humco Holding Group, Inc.	829f3e16-7a9b-4da7-87d2-f58254bda721	2023-12-15	Warnings	Exact identifier application number: M003
Humco Iodides Tincture	ETHYL ALCOHOL	Humco Holding Group, Inc.	d230e3a2-1cde-44a9-82c3-3dc5474b3a72	2023-12-15	Warnings	Exact identifier application number: M003
Humco Hydrogen Peroxide	HYDROGEN PEROXIDE 3%	Humco Holding Group, Inc.	2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd	2023-12-15	Warnings	Exact identifier application number: M003
HUMCO Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Humco Holding Group, Inc.	c220b916-6914-435f-84e2-ba828c9916b1	2023-12-15	Warnings	Exact identifier application number: M003
HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack	ISOPROPYL ALCOHOL	Humco Holding Group, Inc.	8de61fdd-8bb9-4845-9129-97bed0686a68	2023-12-15	Warnings	Exact identifier application number: M003
HUMCO Merthiolate	BENZALKONIUM CHLORIDE	Humco Holding Group, Inc.	864063a5-c6cc-4657-9cd6-51af4673bf98	2023-12-15	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE-IODINE SPRAY 5%	Humco Holding Group, Inc.	a7bb80c4-bbc0-21ea-e053-2995a90a52c1	2023-12-15	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE 10%	Humco Holding Group, Inc.	6064c23b-7c15-208d-e053-2991aa0a00f6	2023-12-15	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE GARGLE 0.5%	Humco Holding Group, Inc.	a7b9ad55-cfeb-6066-e053-2a95a90af975	2023-12-15	Warnings	Exact identifier application number: M003
Rite Aid Povidone Iodine	POVIDONE IODINE 10%	Rite Aid Corporation	5df6ff37-a4ea-d666-e053-2991aa0a9786	2023-12-15	Warnings	Exact identifier application number: M003
Rite Aid Decolorized Iodine	ETHYL ALCOHOL	Rite Aid Corporation	5e0d3664-b02a-ba28-e053-2991aa0a8a4c	2023-12-15	Warnings	Exact identifier application number: M003
De La Cruz Tincture of Iodine	IODINE AND SODIUM IODIDE AND ALCOHOL	DLC Laboratories, Inc.	5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b	2023-12-15	Warnings	Exact identifier application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIAL	ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0c73f4f5-2b1d-84ae-e063-6394a90a5d7b	2023-12-14	Warnings	Exact identifier application number: M003
TaeTu Aftercare	BENZALKONIUM CHLORIDE	Taetu LLC	dec15a4d-1a33-a78a-e053-2995a90a69fe	2023-12-14	Warnings	Exact identifier application number: M003
GNP Idoinde Tincture 2% Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Amerisource Bergen	32ad75b8-abd1-4151-a035-b6c9ae5fc888	2023-12-14	Warnings	Exact identifier application number: M003
Antibacterial Wet Wipes	BENZALKONIUM CHLORIDE	HangZhou YangYi Daily Cosmetics Technology Co., Ltd.	85d3914d-dbb8-5036-e053-2a91aa0a7cd4	2023-12-13	Warnings	Exact identifier application number: M003
AntiochPharma Rapidgel Hand Sanitizer	ALCOHOL	Weeks & Leo	0c57a9ea-de66-3ced-e063-6294a90a4b8d	2023-12-12	Warnings	Exact identifier application number: M003
antiseptic hand sanitizer 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f9b7b6-fed7-10e1-e053-2a95a90a9aa6	2023-12-11	Warnings	Exact identifier application number: M003
AntiochPharma Hand Sanitizer	ALCOHOL	Weeks & Leo	a1a0d368-b004-59b8-e053-2995a90ab4b1	2023-12-11	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