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 83 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XTRA Squeeze Antibacterial Hand Juicy Orange	BENZALKONIUM CHLORIDE	Zhejiang Jifu Daily Chemical Co., Ltd.	2f03b094-c470-d0f4-e063-6394a90a47fc	2025-03-19	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 3pk 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	30997964-e81e-2159-e063-6294a90ad5dc	2025-03-18	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 3pk 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	309abafa-0118-dd48-e063-6294a90a6e9f	2025-03-18	Warnings	Exact identifier application number: M003
Smart Care Strawberry Hand Sanitizer strawberry 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3086faf2-e6e3-a7da-e063-6394a90ace54	2025-03-17	Warnings	Exact identifier application number: M003
AEROCLEANSE Instant Hand Sanitizer	INSTANT HAND SANITIZER	Aero Healthcare	45aad3a4-dc7e-4b51-e054-00144ff88e88	2025-03-12	Warnings	Exact identifier application number: M003
Signature Care Instant Hand Sanitizizer Wipes	ALCOHOL	Yiwu Yangjie Daily Chemicals Co.,Ltd.	0f6a30de-4100-4673-ab9e-256bb137919b	2025-03-11	Warnings	Exact identifier application number: M003
Smart Care Assorted Hand Sanitizer Sweet pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2fa8bf7a-8efc-923d-e063-6394a90a6bbb	2025-03-06	Warnings	Exact identifier application number: M003
Jianerkang One Fluid Ounce Hydrogen Peroxide	HYDROGEN PEROXIDE	Jianerkang Medical Co., Ltd	0cd2cefc-89db-49f9-b187-150c21e7f671	2025-03-06	Warnings	Exact identifier application number: M003
XTRA	BENZALKONIUM CHLORIDE	Zhejiang Jifu Daily Chemical Co., Ltd.	27df3fce-3958-d4ea-e063-6394a90a1785	2025-03-06	Warnings	Exact identifier application number: M003
XTRA	BENZALKONIUM CHLORIDE	MY IMPORTS USA LLC	27f4ff15-5480-8842-e063-6294a90ad35b	2025-03-06	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f982aef-4f46-aa85-e063-6394a90a52b1	2025-03-05	Warnings	Exact identifier application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f9846ce-37ca-a95b-e063-6294a90ad260	2025-03-05	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f988951-39e7-ec02-e063-6294a90aaad7	2025-03-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f98a900-6c7c-0161-e063-6294a90ac675	2025-03-05	Warnings	Exact identifier application number: M003
3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Universal Distribution Center LLC	2f98ba8c-0ab1-e256-e063-6394a90abe8f	2025-03-05	Warnings	Exact identifier application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2f800ea4-b8bb-0cb4-e063-6294a90a7e23	2025-03-04	Warnings	Exact identifier application number: M003
Thera Plus Pain Relief Cleansing	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	513a620e-f69a-488d-8abc-36e2efccdc13	2025-03-04	Warnings	Exact identifier application number: M003
Clorox Hand Sanitizer	ALCOHOL	Brand Buzz LLC	bdd47d2f-5332-1430-e053-2a95a90a1c33	2025-03-03	Warnings	Exact identifier application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2f7c4066-3baa-25f2-e063-6394a90a00eb	2025-03-03	Warnings	Exact identifier application number: M003
Procure Products Hand Sanitizing Wipes	ALCOHOL 70% ANTIBACTERIAL WIPES	TWIN MED LLC	1f378bee-88f7-14cf-e063-6394a90a4888	2025-02-28	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