germstarLuxe

Product NDC: 57915-007
11-digit product format: 579150007
Labeler code: 57915
Product ID: 57915-007_2cd1af31-de7d-d32b-e063-6294a90a430b
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: 2017-02-01
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 · 28 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	57915-007-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57915-007-11	`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	57915-007-17	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-19	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57915-007-11	`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: germstarLuxe
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
471b466f-e3e5-3601-e054-00144ff88e88	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57915-007-01	germstarLuxe	8 g in 1 BOTTLE, SPRAY	SOLUTION	8	7
57915-007-02	germstarLuxe	8 g in 1 BOTTLE, SPRAY	SOLUTION	8	7
57915-007-03	germstarLuxe	8 g in 1 BOTTLE, SPRAY	SOLUTION	8	7
57915-007-10	germstarLuxe	15 g in 1 BOTTLE, SPRAY	SOLUTION	15	7
57915-007-11	germstarLuxe	15 g in 1 BOTTLE, SPRAY	SOLUTION	15	7
57915-007-12	germstarLuxe	15 g in 1 BOTTLE, SPRAY	SOLUTION	15	7
57915-007-13	germstarLuxe	15 g in 1 BOTTLE, SPRAY	SOLUTION	15	7
57915-007-14	germstarLuxe	15 g in 1 BOTTLE, SPRAY	SOLUTION	15	7
57915-007-15	germstarLuxe	118 g in 1 BOTTLE	SOLUTION	118	7
57915-007-16	germstarLuxe	118 g in 1 BOTTLE	SOLUTION	118	7
57915-007-17	germstarLuxe	118 g in 1 BOTTLE	SOLUTION	118	7
57915-007-18	germstarLuxe	118 g in 1 BOTTLE	SOLUTION	118	7
57915-007-19	germstarLuxe	118 g in 1 BOTTLE	SOLUTION	118	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57915-007	GERMSTARLUXE (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]	7	Current NDC, Legacy NDC, 13 package rows	20250130_471b466f-e3e5-3601-e054-00144ff88e88.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 89 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Up and Up Max Pain Relieving Cleansing	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	TARGET CORPORATION	2c3e72eb-5d98-1f3f-e063-6394a90ab00c	2025-01-21	Warnings	Exact identifier application number: M003
Sierrasoft Clear Antibacterial Wash Foam	CHLOROXYLENOL	CWGC LA Inc.	013a36fa-5a9a-46ea-b9d0-ac366257612e	2025-01-20	Warnings	Exact identifier application number: M003
TM TITUS MEDICAL ANTISEPTIC Non Sterile	POVIDONE-IODINE	Titus Medical LLC	690b87d0-d889-43c6-b99e-cd9f26fd682a	2025-01-17	Warnings	Exact identifier application number: M003
TM Titus Medical Povidone Iodine	POVIDONE-IODINE	Titus Medical LLC	af7840c0-239e-4ff6-8d27-614e7d71ca99	2025-01-17	Warnings	Exact identifier application number: M003
Smart Care Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1b125c5d-7041-c71b-e063-6394a90add9b	2025-01-17	Warnings	Exact identifier application number: M003
Berry Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1f128054-4c57-8055-e063-6294a90adc4e	2025-01-17	Warnings	Exact identifier application number: M003
ROAME Moisturizing Hand Sanitizer Cloud 999	ALCOHOL HAND SANITIZER	Roame LLC	2bb1003e-8e4c-8dd8-e063-6294a90ad37d	2025-01-14	Warnings	Exact identifier application number: M003
Antiseptic Towelettes	BENZALKONIUM CHLORIDE	CMC Group Inc.	d7470f98-4278-415b-92e7-9eca2036bc09	2025-01-13	Warnings	Exact identifier application number: M003
Alcohol Cleansing	ISOPROPYL ALCOHOL	CMC Group Inc.	e3985ef1-503a-4193-a5b5-7910aefa7814	2025-01-13	Warnings	Exact identifier application number: M003
Antibiotic Application	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	da436c35-a98f-4df7-9d23-885564734cef	2025-01-13	Warnings	Exact identifier application number: M003
Burn Treatment	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40	2025-01-13	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	CMC Group Inc.	dcca50e6-0935-401d-a23e-be4d1231dde9	2025-01-13	Warnings	Exact identifier application number: M003
Refill 2	BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	45dde3f0-546c-4ec5-beb0-c3d0432f4983	2025-01-13	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	e5cb395f-5037-4b0e-9c9d-2d78b5b01b25	2025-01-13	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	CMC Group Inc.	6f4a4538-7522-4bcf-b3cf-8dea60438a4d	2025-01-13	Warnings	Exact identifier application number: M003
Refill 6	ALCOHOL, WATER	CMC Group, Inc.	7849ae59-5484-4b86-a0b9-ec9b93d9afe0	2025-01-13	Warnings	Exact identifier application number: M003
EVR Povidone lodine Wipe	POVIDONE LODINE	Changzhou Maokang Medical Products Co., Ltd.	2b57e301-74e0-e1db-e063-6294a90a6c18	2025-01-10	Warnings	Exact identifier application number: M003
EVR Sting Relief Wipe	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	2b584d09-916c-00f8-e063-6294a90adbcf	2025-01-10	Warnings	Exact identifier application number: M003
Medzah Ditek Alcohol Prep Pads	ISOPROPYL ALCOHOL	Medzah Industries	4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac	2025-01-10	Warnings	Exact identifier application number: M003
Alcohol Prep Pad-Large	ISOPROPYL ALCOHOL	Global Biomedical Technologies, LLC	93d00515-e93f-48a3-b66b-7d933e734e54	2025-01-10	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	471b466f-e3e5-3601-e054-00144ff88e88	7
1041807	ethanol 0.63 ML/ML Topical Solution	SCD	471b466f-e3e5-3601-e054-00144ff88e88	7
1041807	ethanol 63 % Topical Solution	SY	471b466f-e3e5-3601-e054-00144ff88e88	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57915-007-01	57915000701	8 g in 1 BOTTLE, SPRAY (57915-007-01)	8 g	2017-02-01	0000-00-00	No	No	Current
57915-007-02	57915000702	8 g in 1 BOTTLE, SPRAY (57915-007-02)	8 g	2017-02-01	0000-00-00	No	No	Current
57915-007-03	57915000703	8 g in 1 BOTTLE, SPRAY (57915-007-03)	8 g	2017-02-01	0000-00-00	No	No	Current
57915-007-10	57915000710	15 g in 1 BOTTLE, SPRAY (57915-007-10)	15 g	2019-02-01	0000-00-00	No	No	Current
57915-007-11	57915000711	15 g in 1 BOTTLE, SPRAY (57915-007-11)	15 g	2019-02-01	0000-00-00	No	No	Current
57915-007-12	57915000712	15 g in 1 BOTTLE, SPRAY (57915-007-12)	15 g	2019-02-01	0000-00-00	No	No	Current
57915-007-13	57915000713	15 g in 1 BOTTLE, SPRAY (57915-007-13)	15 g	2019-02-01	0000-00-00	No	No	Current
57915-007-14	57915000714	15 g in 1 BOTTLE, SPRAY (57915-007-14)	15 g	2019-02-01	0000-00-00	No	No	Current
57915-007-15	57915000715	118 g in 1 BOTTLE (57915-007-15)	118 g	2019-02-01	0000-00-00	No	No	Current
57915-007-16	57915000716	118 g in 1 BOTTLE (57915-007-16)	118 g	2019-02-01	0000-00-00	No	No	Current
57915-007-17	57915000717	118 g in 1 BOTTLE (57915-007-17)	118 g	2019-02-01	0000-00-00	No	No	Current
57915-007-18	57915000718	118 g in 1 BOTTLE (57915-007-18)	118 g	2019-02-01	0000-00-00	No	No	Current
57915-007-19	57915000719	118 g in 1 BOTTLE (57915-007-19)	118 g	2019-02-01	0000-00-00	No	No	Current