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 104 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safly BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	5cd9043e-daf2-43eb-9568-54775fc4f84a	2024-05-15	Warnings	Exact identifier application number: M003
Noshinku Bergamot Hand Sanitizer	ALCOHOL	Noshinku	53fea81e-4482-6fae-e054-00144ff8d46c	2024-05-14	Warnings	Exact identifier application number: M003
Noshinku Eucalyptus Hand Sanitizer	ALCOHOL	Noshinku	9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0	2024-05-14	Warnings	Exact identifier application number: M003
Noshinku Lavender Hand Sanitizer	ALCOHOL	Noshinku	a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf	2024-05-14	Warnings	Exact identifier application number: M003
LEADER 2% Mild Iodine Tincture	IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID	Cardinal Health, 110 dba Leader	7f810b92-60f6-2f72-e053-2991aa0ab973	2024-05-13	Warnings	Exact identifier application number: M003
Leader Decolorized Iodine	ALCOHOL LIQUID	Cardinal Health, 110 dba Leader	822f6f28-956f-dd82-e053-2991aa0ae752	2024-05-13	Warnings	Exact identifier application number: M003
Inverness Ear Care	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	180a2995-334c-2e93-e063-6294a90aecf7	2024-05-09	Warnings	Exact identifier application number: M003
Helzberg Diamonds Ear Care	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	180a3776-0edd-26f3-e063-6294a90a740d	2024-05-09	Warnings	Exact identifier application number: M003
Ulta Beauty Ear Care	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	180a37f4-8718-3e40-e063-6294a90acaad	2024-05-09	Warnings	Exact identifier application number: M003
Guardian Vaginal	BENZALKONIUM CHLORIDE	Eastern Century Pharmaceuticals	1605ba44-02b7-4c72-9fec-89a5aa962b44	2024-04-24	Warnings	Exact identifier application number: M003
Inverness Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	0ccd72e7-16a2-47c7-9ce6-dffb63a0344b	2024-04-18	Warnings	Exact identifier application number: M003
Lovisa Piercing Care Solution	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	74f46b81-cc5b-4e3f-a36e-0bd86d370c22	2024-04-18	Warnings	Exact identifier application number: M003
CliniClean BZK Cleansing Contains Benzalkonium Chloride	BENZALKONIUM CHLORIDE	HR HealthCare	b6916466-0931-408f-a430-0797a449c32e	2024-04-18	Warnings	Exact identifier application number: M003
Handy Solutions First Aid Kit	BENZALKONIUM CHLORIDE	Navajo Manufacturing Company Inc.	130237ff-3db4-1288-e063-6394a90ab1af	2024-04-16	Warnings	Exact identifier application number: M003
BZK	BENZALKONIUM CHLORIDE	Henry Schein Inc.	ff877b63-fa58-4770-a882-694eda33203b	2024-04-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	8e1f35ff-d4e6-4940-ad8f-dce2b73e595d	2024-04-01	Warnings	Exact identifier application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICAS	BENZALKONIUM CHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	b267e186-cf7a-458f-9c28-a48a8554af40	2024-04-01	Warnings	Exact identifier application number: M003
Antiseptic Povidone Iodine Prep Pad	POVIDONE-IODINE	M-star (Hubei) Health&Care Products Co., Ltd.	fc76c1f3-b48e-4276-890d-5b8e5a894e62	2024-04-01	Warnings	Exact identifier application number: M003
Novex Hand Sanitizer	BENZALKONIUM CHLORIDE	Natural Essentials, Inc.	8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3	2024-03-20	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE 0.13%	Trifecta Pharmaceuticals USA, LLC.	13f1c70f-3b44-8eef-e063-6294a90af634	2024-03-18	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