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 109 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RevitaDERM Wound Care	BENZALKONIUM CHLORIDE	Blaine Labs Inc.	9254dada-4e32-43a0-892b-c488d68e23e7	2023-12-21	Warnings	Exact identifier application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep Pad	ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD	Spectra Medical Devices, LLC	07d20040-9dd9-0aba-e063-6294a90ab7cf	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodides	ALCOHOL	Strategic Sourcing Services LLC	8d9f2112-c678-4559-b567-9d6d287c5fa3	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Strategic Sourcing Services LLC	72eeb3e6-c0a1-4b18-87f1-8db06f9bd111	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	cbe02fa1-c167-4b77-8f63-817362090e19	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	fbd2aa69-b1c7-4a28-9642-a436ae09faaf	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Market Association	9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Chain Drug Market Association	55c970ed-13a9-4ea2-a8cb-aaf14d3a214d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodides Tincture	ETHYL ALCOHOL	Chain Drug Market Association	71aedfd5-e81f-4b69-b163-527ff1ce30b1	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Merthiolate	BENZALKONIUM CHLORIDE	Chain Drug Market Association	5b7303b9-b8c4-4e7c-876f-70ed76443055	2023-12-20	Warnings	Exact identifier application number: M003
Premier Value Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Consortium	5cc9d782-5f7e-27d9-e053-2991aa0a2428	2023-12-20	Warnings	Exact identifier application number: M003
Harris Teeter Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Harris Teeter, LLC	5c88d7cb-2917-54e9-e053-2991aa0a0bd9	2023-12-20	Warnings	Exact identifier application number: M003
CVS Iodine	IODINE, SODIUM IODIDE AND ALCOHOL	CVS Pharmacy	b11db4e5-6a6d-4d4a-b980-600692b54176	2023-12-20	Warnings	Exact identifier application number: M003
CVS Povidone-Iodine	POVIDONE IODINE	CVS Pharmacy	402d571f-e1e8-43fd-9e7b-05aab1837905	2023-12-20	Warnings	Exact identifier application number: M003
Sanitizing wipes with aloe Grapefruit Grove	ALCOHOL	The Honest Company	faa3690b-ce0d-43d4-9e5c-f2ce77daabe7	2023-12-19	Warnings	Exact identifier application number: M003
Sanitizing Wipes Fragrance Free	ALCOHOL	The Honest Company	0ce3e7ee-aa50-16bc-e063-6294a90a527d	2023-12-19	Warnings	Exact identifier application number: M003
sunmark Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	46da2750-37d1-4ed1-baf3-1fd426617567	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Iodine	IODINE, SODIUM IODIDE, ALCOHOL	Strategic Sourcing Services LLC	e8dae2d6-58b1-4c4e-a4c1-371db055b7ae	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	515dd733-1b44-4df0-928f-a3b202b5f9c2	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e	2023-12-19	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