Gentian Violet 2%

Product NDC: 54633-014
11-digit product format: 546330014
Labeler code: 54633
Product ID: 54633-014_47e3681f-3a81-c942-e063-6294a90a530c
Type: HUMAN OTC DRUG
Nonproprietary name: gentian violet 2%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: The Podiatree Company
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-14
Substance: GENTIAN VIOLET
Active strength: 2 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Gentian Violet 2%
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTIAN VIOLET	2 g/100mL

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
60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54633-014-02	Gentian Violet 2%	59.14 mL in 1 BOTTLE, PLASTIC	SOLUTION	59.14		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54633-014-02	ML - Milliliter	54633-014	4884732a-fc88-4e16-af9f-31eb44bf42db	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GENTIAN VIOLET	ACTIVE INGREDIENT	J4Z741D6O5	GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]	1
GENTIAN VIOLET CATION	ACTIVE MOIETY	3GVJ31T6YY	GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54633-014	GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]	2	Current NDC, Legacy NDC, 1 package rows	20171220_60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8.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 9 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MISTIFY WATERMELON HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574bf021-6352-e3fc-e063-6394a90ad6de	2026-07-23	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, Fresh	BENZALKONIUM CHLORIDE	Quest USA Corp	5719809b-1c74-4bf3-e063-6294a90ab008	2026-07-23	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE 5%	Walgreen Company	262ea2c8-f571-1c0b-e063-6394a90af20b	2026-07-22	Warnings	Exact identifier application number: M003
Verifine Alcohol Swabs	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co.,LTD.	5738a502-c5ab-21b0-e063-6294a90a20a7	2026-07-22	Warnings	Exact identifier application number: M003
KeepGoing Sting Relief Pad	BENZOCAINE AND ISOPROPYL ALCOHOL	J&A Digital Inc.	a630db1b-1674-4659-a60f-56994b0a1564	2026-07-22	Warnings	Exact identifier application number: M003
KeepGoing Alcohol Prep Pad	ISOPROPYL ALCOHOL	J&A Digital Inc.	5d1e776b-4027-4d05-b02f-8a2701d7bc7a	2026-07-22	Warnings	Exact identifier application number: M003
KeepGoing Non Sting Cleaning Wipe	BENZALKONIUM CHLORIDE	J&A Digital Inc.	1a6303ce-8df7-4e8b-93f2-e162fdd2540c	2026-07-22	Warnings	Exact identifier application number: M003
Lights Povidone Iodine Swabsticks	POVIDONE-IODINE	Lights Medical Manufacture Co., Ltd.	664bbf9f-650a-45fd-b9b8-d93f0ba63190	2026-07-22	Warnings	Exact identifier application number: M003
DOCTOR INKS TOPICAL ANTISEPTIC	BENZALKONIUM CHLORIDE	Enviro Specialty Chemicals Inc	d503a2db-e326-4a31-bc6a-5034ad74bf0b	2026-07-21	Warnings	Exact identifier application number: M003
MY-SHIELD TOPICAL ANTISEPTIC	BENZALKONIUM CHLORIDE	Enviro Specialty Chemicals Inc	c2c1f5d9-cd6e-4314-9dfc-961ed877c293	2026-07-21	Warnings	Exact identifier application number: M003
Germ Free Topical Antiseptic	BENZALKONIUM CHLORIDE	Enviro Specialty Chemicals Inc	5e004412-1797-4cbf-83e3-7001286ad157	2026-07-21	Warnings	Exact identifier application number: M003
Midnight Magic Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	5721d186-ec6d-fa26-e063-6294a90a76d2	2026-07-21	Warnings	Exact identifier application number: M003
McKesson PVP Prep Solution	POVIDONE-IODINE	McKesson Medical-Surgical	33fa233c-b43c-42d8-af37-a58f098a0d51	2026-07-21	Warnings	Exact identifier application number: M003
Twisted Caramel Apple Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	572a82e3-93ec-9af4-e063-6294a90a9c26	2026-07-21	Warnings	Exact identifier application number: M003
Molten Marshmallow Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	572aa67e-52f7-b424-e063-6394a90ac4ae	2026-07-21	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITY	BENZALKONIUM CHLORIDE	Quest USA Corp	57135b3f-884d-1a03-e063-6294a90ae3e9	2026-07-20	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCO	BENZALKONIUM CHLORIDE	Quest USA Corp	571709fb-ca50-f7b1-e063-6394a90a8d35	2026-07-20	Warnings	Exact identifier application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPE	BENZALKONIUM CHLORIDE	Quest USA Corp	57180e7a-1134-9ecd-e063-6294a90af5bf	2026-07-20	Warnings	Exact identifier application number: M003
Biopure 70% Isopropyl Alcohol Wipe	ISOPROPYL ALCOHOL, WIPE	QUEST USA CORP	3a7932c4-6f90-a008-e063-6294a90aa769	2026-07-19	Warnings	Exact identifier application number: M003
Urgent First Aid BZK Antiseptic Wipe	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	5701c813-4346-a727-e063-6294a90a8e05	2026-07-19	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	60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8	3
313997	gentian violet 20 MG/ML Topical Solution	SCD	60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8	3
313997	gentian violet 2 % Topical Solution	SY	60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54633-014-02	54633001402	59.14 mL in 1 BOTTLE, PLASTIC (54633-014-02)	59.14 ml	2014-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentian Violet 2% - The Podiatree Company	The Podiatree Company	2026-01-08	HUMAN OTC DRUG LABEL	3
Gentian Violet 2% - The Podiatree Company \| EMS Contract Packaging	The Podiatree Company \| EMS Contract Packaging	2014-10-14	HUMAN OTC DRUG LABEL	1