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 112 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BZK Cleansing Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	52c74f75-d7ef-481b-b580-fba402d03d75	2023-11-09	Warnings	Exact identifier application number: M003
MK Alcohol Swabstick Sterile	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	48d198f0-d505-4e45-b7c9-dd70658fd5fa	2023-11-09	Warnings	Exact identifier application number: M003
Maokang 3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Changzhou Maokang Medical Products Co., Ltd	b4b478b9-426d-4864-a64c-31de9bbf5dc3	2023-11-09	Warnings	Exact identifier application number: M003
MK Sting Relief Pads	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	1a60dd1b-0116-42a2-a501-4f74e326a2e9	2023-11-09	Warnings	Exact identifier application number: M003
terrasil First Aid Antiseptic Wound and Burn Care Kit	HEXYLRESORCINOL	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	5ddb84e9-cdf7-4034-acd2-625f8d6e4601	2023-11-08	Warnings	Exact identifier application number: M003
Inverness Ear Piercing	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	bcec8099-939b-4cff-b388-f4046164f2d4	2023-11-08	Warnings	Exact identifier application number: M003
Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	98b70f22-cd53-e61b-e053-2995a90a730d	2023-11-06	Warnings	Exact identifier application number: M003
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	Degasa, S.A. de C.V.	b4145aa4-d810-4c20-8493-311a7e222eb9	2023-11-05	Warnings	Exact identifier application number: M003
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	DEGASA SA DE CV	26bae595-6e76-4946-b98f-1aba2e69250d	2023-11-05	Warnings	Exact identifier application number: M003
Hand Sanitizer	ETHYL ALCOHOL	Raining Rose, Inc.	416267f2-85c5-6633-e054-00144ff8d46c	2023-11-03	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	70%ISOPROPYL ALCOHOL	Raya Pharmaceuticals LLC	da108e12-4327-db1c-e053-2a95a90a211b	2023-10-27	Warnings	Exact identifier application number: M003
POVIDONE-IODINE PAD- povidone-iodine swab	POVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)	Raya Pharmaceuticals LLC	dbcbd1be-5274-3de3-e053-2995a90abf1c	2023-10-27	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	4bfea435-f40d-4976-8450-a699f7640c65	2023-10-23	Warnings	Exact identifier application number: M003
Sting Relief	BENZOCAINE, ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	3a32398a-3f7e-4da0-bb1d-b3f369914b2a	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a504b8-b0c0-030a-e054-00144ff88e88	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a504b8-b0af-030a-e054-00144ff88e88	2023-10-23	Warnings	Exact identifier application number: M003
BZK	BENZALKONIUM CHLORIDE	Jianerkang Medical Co., Ltd	d96c6ad2-c7e9-4079-9db2-59d108f284bb	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5690c-08bf-5092-e054-00144ff8d46c	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5726f-d314-50d9-e054-00144ff8d46c	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5690c-08ad-5092-e054-00144ff8d46c	2023-10-23	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