Germstar Premium Hand Sanitizer

Product NDC: 57915-008
11-digit product format: 579150008
Labeler code: 57915
Product ID: 57915-008_2c7baede-035b-8ba4-e063-6294a90a4a7d
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: 2017-03-01
Substance: ALCOHOL
Active strength: 630 g/1000g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
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	57915-008-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-008-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-008-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-008-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-008-05	`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	57915-008-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-008-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-008-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-008-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-008-05	`0efc9e666f02…`	`f202fb6c5f17…`

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: Germstar Premium Hand Sanitizer
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
489652af-7333-628a-e054-00144ff8d46c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57915-008-01	Germstar Premium Hand Sanitizer	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	4
57915-008-02	Germstar Premium Hand Sanitizer	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	4
57915-008-03	Germstar Premium Hand Sanitizer	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	4
57915-008-04	Germstar Premium Hand Sanitizer	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	4
57915-008-05	Germstar Premium Hand Sanitizer	59 g in 1 BOTTLE, SPRAY	SOLUTION	59	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57915-008	GERMSTAR PREMIUM HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC LLC]	4	Current NDC, Legacy NDC, 5 package rows	20250126_489652af-7333-628a-e054-00144ff8d46c.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 98 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dynarex Green	ALCOHOL	Dynarex Corporation	072572be-49dd-4594-bc40-b56db57ada5b	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	CHLOROXYLENOL	Dynarex Corporation	59b098d2-08de-4fdb-a209-ae226abf37d6	2024-11-20	Warnings	Exact identifier application number: M003
Baby Wipes	PROPYLENE GLYCOL	Shandong Yayun Sanitary Products Co., Ltd.	aeb9a12c-955f-5030-e053-2995a90a2dd6	2024-11-20	Warnings	Exact identifier application number: M003
Pet wipes	BENZALKONIUM CHLORIDE	Shandong Yayun Sanitary Products Co., Ltd.	2764ea79-32d8-b7f6-e063-6394a90a5501	2024-11-20	Warnings	Exact identifier application number: M003
Premium Hand Sanitizer	ETHANOL	MCKESSON MEDICAL-SURGICAL INC.	a9514466-e0c6-4792-984a-9f07d94ee887	2024-11-18	Warnings	Exact identifier application number: M003
MARVEL BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	93ed0bb4-834d-44ca-9c0a-20086fc09ab8	2024-11-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	McKesson Medical-Surgical Inc.	98b0bcc2-539b-4471-ba98-bbe17bb881bd	2024-11-15	Warnings	Exact identifier application number: M003
CVS Health Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	CVS PHARMACY, INC	7a930a5e-5b69-428f-9cbb-d03dae180295	2024-11-12	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Prep Pad	POVIDONE-IODINE	Acme United Corporation	509b6c8e-6a9f-2656-e054-00144ff8d46c	2024-11-09	Warnings	Exact identifier application number: M003
MED NAP Cleansing Towelette	BENZALKONIUM CHLORIDE	Acme United Corporation	d92cd45a-234c-4872-e053-2a95a90a3e1c	2024-11-09	Warnings	Exact identifier application number: M003
MED NAP Obstetrical Towelette	BENZALKONIUM CHLORIDE	Acme United Corporation	d83d2fab-6972-9b18-e053-2995a90a5cb5	2024-11-09	Warnings	Exact identifier application number: M003
MED NAP Benzalkonium Chloride Antiseptic	BENZALKONIUM CHLORIDE	Acme United Corporation	d7c404c1-c765-a67c-e053-2995a90a6b8e	2024-11-09	Warnings	Exact identifier application number: M003
Barbie BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	d675eb91-80a8-4874-a2b0-c2bf69264911	2024-11-08	Warnings	Exact identifier application number: M003
Barbie ALCOHOL WIPE	ISOPROPYL ALCOHOL	Ashtel Studios, Inc.	a4a6beb0-5781-4d74-9120-7ca64e035c23	2024-11-08	Warnings	Exact identifier application number: M003
MARVEL ALCOHOL WIPE	ISOPROPYL ALCOHOL	Ashtel Studios, Inc.	f6cd4757-d6e0-46bd-827f-3f380c71858f	2024-11-07	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	HAND SANITIZER	Raining Rose, Inc.	2656d129-df88-4489-e063-6394a90a4b49	2024-11-07	Warnings	Exact identifier application number: M003
HealthWise Advanced Hand Sanitizer	ETHYL ALCOHOL 70%	Veridian Healthcare	261bd056-c2f9-2a69-e063-6394a90af8df	2024-11-04	Warnings	Exact identifier application number: M003
Hand Sanitizer Cucumber Aloe	ORGANIC ETHYL ALCOHOL	Whole Foods Market, Inc.	0588ae1b-f29a-e1b6-e063-6394a90a0de1	2024-11-02	Warnings	Exact identifier application number: M003
Hand Sanitizer Cucumber Aloe	ETHYL ALCOHOL	Whole Foods Market, Inc.	074334af-c26e-4126-e063-6394a90ae4c4	2024-11-02	Warnings	Exact identifier application number: M003
Hand Sanitizer Orange Blossom	ORGANIC ETHYL ALCOHOL	Whole Foods Market, Inc.	07f708d1-11c8-eb50-e063-6294a90a3a81	2024-11-02	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	489652af-7333-628a-e054-00144ff8d46c	4
1041807	ethanol 0.63 ML/ML Topical Solution	SCD	489652af-7333-628a-e054-00144ff8d46c	4
1041807	ethanol 63 % Topical Solution	SY	489652af-7333-628a-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57915-008-01	57915000801	59 g in 1 BOTTLE, SPRAY (57915-008-01)	59 g	2017-03-01	0000-00-00	No	No	Current
57915-008-02	57915000802	59 g in 1 BOTTLE, SPRAY (57915-008-02)	59 g	2017-03-01	0000-00-00	No	No	Current
57915-008-03	57915000803	59 g in 1 BOTTLE, SPRAY (57915-008-03)	59 g	2017-03-01	0000-00-00	No	No	Current
57915-008-04	57915000804	59 g in 1 BOTTLE, SPRAY (57915-008-04)	59 g	2017-03-01	0000-00-00	No	No	Current
57915-008-05	57915000805	59 g in 1 BOTTLE, SPRAY (57915-008-05)	59 g	2017-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Germstar Premium Hand Sanitizer	Soaptronic LLC \| Soaptronic, LLC	2025-01-24	HUMAN OTC DRUG LABEL	4