Humco Gentian Violet 1%

Product NDC: 0395-1003
11-digit product format: 003951003
Labeler code: 0395
Product ID: 0395-1003_5634a424-3290-eefc-e063-6294a90a2290
Type: HUMAN OTC DRUG
Nonproprietary name: Gentian Violet 1%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-01-01
Marketing end: 2029-02-01
Substance: GENTIAN VIOLET
Active strength: 10 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 1%

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTIAN VIOLET	10 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
310481	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
7b4e6572-cb44-491d-8063-f7519307a8e5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-1003-92	Humco Gentian Violet 1%	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-1003-92	ML - Milliliter	0395-1003	af2eb031-223d-422e-801b-7005137c6826	1	2014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-1003	HUMCO GENTIAN VIOLET 1% (GENTIAN VIOLET 1%) LIQUID [HUMCO HOLDING GROUP, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20231216_7b4e6572-cb44-491d-8063-f7519307a8e5.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 86 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Cucumber Melon	ETHYL ALCOHOL	Rejoice International	021fa2a0-d2ea-4699-a3d8-3c0af18c5aa3	2025-02-12	Warnings	Exact identifier application number: M003
XtraCare Lavender Chamomile	ETHYL ALCOHOL	Rejoice International	6e611e87-1835-49f8-aa52-b724bd251527	2025-02-12	Warnings	Exact identifier application number: M003
XtraCare Sweet Pea Blossom	ETHYL ALCOHOL	Rejoice International	1a5408f2-910c-4c6a-b6b3-c1304dd1cdf0	2025-02-12	Warnings	Exact identifier application number: M003
XtraCare Warm Vanilla	ETHYL ALCOHOL	Rejoice International	46e7b4fa-3722-4487-9325-f8552ea92acf	2025-02-12	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer 2oz Bonus pack	ETHYL ALCOHOL	Rejoice International Inc.	5b209df6-d896-170c-e053-2a91aa0a52a8	2025-02-12	Warnings	Exact identifier application number: M003
Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus pack	ETHYL ALCOHOL	Rejoice International Inc.	6e62eb50-ebb8-361e-e053-2991aa0aba6f	2025-02-12	Warnings	Exact identifier application number: M003
Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus pack	ETHYL ALCOHOL	Rejoice International Inc.	6e6585a3-61e1-30ec-e053-2a91aa0a6039	2025-02-12	Warnings	Exact identifier application number: M003
Smart Care Assorted Licensed Sanitizer Spider Man 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2dedab76-3f5a-febf-e063-6394a90a6993	2025-02-12	Warnings	Exact identifier application number: M003
Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus pack	ETHYL ALCOHOL	Rejoice International Inc.	6e65856c-0e14-1ab6-e053-2991aa0a3f3e	2025-02-12	Warnings	Exact identifier application number: M003
Smart Care Assorted Licensed Sanitizer Barbie 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2dfd2ffd-a85a-f63e-e063-6294a90a6a5e	2025-02-12	Warnings	Exact identifier application number: M003
Smart Care Assorted Licensed Sanitizer Crayola 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2dfd4acb-451b-12d3-e063-6294a90a4873	2025-02-12	Warnings	Exact identifier application number: M003
Smart Care Assorted Licensed Sanitizer Hot Wheels 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2dfdd225-24f4-6d57-e063-6394a90a8a24	2025-02-12	Warnings	Exact identifier application number: M003
Smart Care Cucumber Melon Hand Sanitizer 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2dfe0ac7-99d5-aac3-e063-6294a90a31b3	2025-02-12	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent	ISOPROPYL ALCOHOL	Good Sense (Geiss, Destin & Dunn, Inc.)	ac66be77-d358-44ea-8904-88186a7c2bbb	2025-02-07	Warnings	Exact identifier application number: M003
Rubbing Alcohol 70 Percent Isopropyl	ISOPROPYL ALCOHOL	Harris Teeter, LLC	4196dd97-9041-4712-8196-02237a3b0cb2	2025-02-07	Warnings	Exact identifier application number: M003
Isopropyl alcohol 91 percent	ISOPROPYL ALCOHOL	Harris Teeter, LLC	1b044f47-45e1-40a3-81b0-2717ed425f16	2025-02-07	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International Corp.	4e042f5b-3f0c-1830-e054-00144ff88e88	2025-02-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International Corp.	4e04fa70-c25d-4499-e054-00144ff8d46c	2025-02-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International Corp.	4e05cceb-b8f3-48f7-e054-00144ff88e88	2025-02-06	Warnings	Exact identifier application number: M003
Hand Sanitizer 1.8 oz Antiseptic	ETHYL ALCOHOL	REJOICE INTERNATIONAL CORP.	a0313f20-11dc-6c7d-e053-2a95a90a60f1	2025-02-06	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
310481	gentian violet 1 % Topical Solution	PSN	7b4e6572-cb44-491d-8063-f7519307a8e5	6
310481	gentian violet 10 MG/ML Topical Solution	SCD	7b4e6572-cb44-491d-8063-f7519307a8e5	6
310481	gentian violet 1 % Topical Solution	SY	7b4e6572-cb44-491d-8063-f7519307a8e5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-1003-92	00395100392	59 mL in 1 BOTTLE, PLASTIC (0395-1003-92)	59 ml	2017-11-13	2029-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humco Gentian Violet 1%	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2026-07-09	HUMAN OTC DRUG LABEL	7