germstarONE unscented

Product NDC: 57915-021
11-digit product format: 579150021
Labeler code: 57915
Product ID: 57915-021_29a593b8-ff9f-bc5c-e063-6394a90a52cc
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

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 unscented
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
a6a798bd-09cb-1853-e053-2995a90a27f9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57915-021-01	germstarONE unscented	946 g in 1 BAG	SOLUTION	946	11
57915-021-02	germstarONE unscented	474 g in 1 BOTTLE, PUMP	SOLUTION	474	11
57915-021-03	germstarONE unscented	236 g in 1 BOTTLE, SPRAY	SOLUTION	236	11
57915-021-04	germstarONE unscented	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57915-021	GERMSTARONE UNSCENTED (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]	11	Current NDC, Legacy NDC, 4 package rows	20241225_a6a798bd-09cb-1853-e053-2995a90a27f9.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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone-Iodine Pad	POVIDONE-IODINE	Shandong Haiyan Medical Manufacture Co., Ltd.	c9187a07-92d5-15ac-e053-2995a90af4cb	2022-03-19	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Shandong Haiyan Medical Manufacture Co., Ltd.	1a117840-22d0-4a88-b1a6-e43162a444ab	2022-03-19	Warnings	Exact identifier application number: M003
FIRSTAR BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	28591a97-9291-48c8-a8e3-c419180331b3	2021-07-06	Warnings	Exact identifier application number: M003
Bactine Max	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	28e8a311-20a4-45a1-8d5d-ca42b101c275	2021-02-24	Warnings	Exact identifier application number: M003
Hand Sanitizer Lemon 2oz	ALCOHOL	Ningbo Rejoice International	b0a4159a-cb07-4ce6-e053-2995a90a76e7	2020-10-02	Warnings	Exact identifier application number: M003
Sanix Alcohol Hand Rub	ALCOHOL	Topiderm, Inc	a4fbb714-4f20-400a-ab98-f1c8807ce6fc	2020-03-24	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	a6a798bd-09cb-1853-e053-2995a90a27f9	11
1041807	ethanol 0.63 ML/ML Topical Solution	SCD	a6a798bd-09cb-1853-e053-2995a90a27f9	11
1041807	ethanol 63 % Topical Solution	SY	a6a798bd-09cb-1853-e053-2995a90a27f9	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57915-021-01	57915002101	946 g in 1 BAG (57915-021-01)	946 g	2020-04-30	0000-00-00	No	No	Current
57915-021-02	57915002102	474 g in 1 BOTTLE, PUMP (57915-021-02)	474 g	2020-04-30	0000-00-00	No	No	Current
57915-021-03	57915002103	236 g in 1 BOTTLE, SPRAY (57915-021-03)	236 g	2020-04-30	0000-00-00	No	No	Current
57915-021-04	57915002104	59 g in 1 BOTTLE, SPRAY (57915-021-04)	59 g	2020-04-30	0000-00-00	No	No	Current