Humco Gentian Violet 2%

Product NDC: 0395-1005
11-digit product format: 003951005
Labeler code: 0395
Product ID: 0395-1005_5634c662-c67b-1824-e063-6294a90ac331
Type: HUMAN OTC DRUG
Nonproprietary name: Gentian Violet 2%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-01-01
Marketing end: 2027-07-01
Substance: GENTIAN VIOLET
Active strength: 20 mg/mL
NDC exclude flag: No
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: Humco Gentian Violet 2%

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTIAN VIOLET	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J4Z741D6O5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313997	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
a07f61e5-0215-419a-a68a-1d814417c35f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-1005-92	Humco Gentian Violet 2%	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-1005-92	ML - Milliliter	0395-1005	ccca0681-0c63-4c85-8642-4c990acc6170	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GENTIAN VIOLET	ACTIVE INGREDIENT	J4Z741D6O5	HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]	1
GENTIAN VIOLET CATION	ACTIVE MOIETY	3GVJ31T6YY	HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-1005	HUMCO GENTIAN VIOLET 2% (GENTIAN VIOLET 2%) LIQUID [HUMCO HOLDING GROUP, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20231216_a07f61e5-0215-419a-a68a-1d814417c35f.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 84 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl alcohol 50 percent Wintergreen ReadyInCase	ISOPROPYL ALCOHOL	P & L Development, LLC	f9ff67b0-c4ad-4162-b3ef-27a85ed0da25	2025-02-18	Warnings	Exact identifier application number: M003
Inverness Home Ear Piercing Kit	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	80909a34-21da-4c54-bb62-fd986fd24b04	2025-02-17	Warnings	Exact identifier application number: M003
Inverness EAR CARE ANTISEPTIC	BENZALKONIUM CHLORIDE	The Richline Group	ac42d2f1-69e3-45f6-8002-d45ebed5ee22	2025-02-17	Warnings	Exact identifier application number: M003
Licensed Hand Sanitizer Barbie 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2e1507f1-a88f-4ef8-e063-6294a90a92fd	2025-02-14	Warnings	Exact identifier application number: M003
Licensed Hand Sanitizer Hot Wheels 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2e159f8f-352c-45ca-e063-6394a90adf9b	2025-02-14	Warnings	Exact identifier application number: M003
Licensed Hand Sanitizer Crayola 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2e1633f1-4b59-6eea-e063-6294a90ae61b	2025-02-14	Warnings	Exact identifier application number: M003
Licensed Hand Sanitizer Spider man 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2e16c9bc-223d-0c65-e063-6294a90a4815	2025-02-14	Warnings	Exact identifier application number: M003
Betadine	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	3007da5f-e2ea-4f3a-905c-770782da014e	2025-02-14	Warnings	Exact identifier application number: M003
50 percent Isopropyl alcohol	ISOPROPYL ALCOHOL	Whole Foods Market	6cb4ccca-96e7-43cb-ae05-95a411e71255	2025-02-14	Warnings	Exact identifier application number: M003
Hand Sanitizer 1.8 oz Lemon Ice	ETHYL ALCOHOL	Ningbo Rejoice International	a266624f-2175-2fd4-e053-2995a90a3305	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.	ETHYL ALCOHOL	Ningbo Rejoice International	a2677a83-8f9a-7470-e053-2a95a90aa289	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pk	ETHYL ALCOHOL	Ningbo Rejoice International	a2695f96-ef8c-bba6-e053-2a95a90a243e	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Original 1.8 oz	ETHYL ALCOHOL	Ningbo Rejoice International	a26a866a-bb5f-4b5f-e053-2995a90a9745	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pk	ETHYL ALCOHOL	Ningbo Rejoice International	a269e72d-c74b-71ed-e053-2995a90ac147	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Vitamin E	ETHYL ALCOHOL	Ningbo Rejoice International	a269a222-95cb-098c-e053-2995a90a21e7	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Antibacterial Vitamin E	ETHYL ALCOHOL	Ningbo Rejoice International	a346ebd2-fc31-b574-e053-2995a90a0d3a	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Antibacterial Vitamin E	ETHYL ALCOHOL	Ningbo Rejoice International	a7364361-f8ad-fc71-e053-2995a90a68a1	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Antibacterial Vitamin E	ETHYL ALCOHOL	Ningbo Rejoice International	a73698ca-2097-3f7d-e053-2a95a90a638a	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer 2pk Lemon 2oz	ALCOHOL	Ningbo Rejoice International	b08ea7ef-a595-6bef-e053-2a95a90a68fb	2025-02-13	Warnings	Exact identifier application number: M003
Hand Sanitizer Original 8oz	ALCOHOL	Ningbo Rejoice International	b08ec92b-e63e-2dab-e053-2995a90a0948	2025-02-13	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J4Z741D6O5	GENTIAN VIOLET	548-62-9	GENTIAN VIOLET

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313997	gentian violet 2 % Topical Solution	PSN	a07f61e5-0215-419a-a68a-1d814417c35f	9
313997	gentian violet 20 MG/ML Topical Solution	SCD	a07f61e5-0215-419a-a68a-1d814417c35f	9
313997	gentian violet 2 % Topical Solution	SY	a07f61e5-0215-419a-a68a-1d814417c35f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-1005-92	00395100592	59 mL in 1 BOTTLE, PLASTIC (0395-1005-92)	59 ml	2017-11-13	2027-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humco Gentian Violet 2%	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2026-07-09	HUMAN OTC DRUG LABEL	10