Gentian Violet

Product NDC: 10095-101
11-digit product format: 100950101
Labeler code: 10095
Product ID: 10095-101_419cc9a2-bfdf-a516-e063-6294a90a065c
Type: HUMAN OTC DRUG
Nonproprietary name: Gentian Violet
Dosage form: SOLUTION
Route: TOPICAL
Labeler: World Perfumes Inc
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-01
Substance: GENTIAN VIOLET
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTIAN VIOLET	1 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
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
419cc9a2-bfde-a516-e063-6294a90a065c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10095-101-02	Gentian Violet	30 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	30		1

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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone-Iodine Pad	POVIDONE-IODINE	Shandong Haiyan Medical Manufacture Co., Ltd.	c9187a07-92d5-15ac-e053-2995a90af4cb	2022-03-19	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Shandong Haiyan Medical Manufacture Co., Ltd.	1a117840-22d0-4a88-b1a6-e43162a444ab	2022-03-19	Warnings	Exact identifier application number: M003
FIRSTAR BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	28591a97-9291-48c8-a8e3-c419180331b3	2021-07-06	Warnings	Exact identifier application number: M003
Bactine Max	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	28e8a311-20a4-45a1-8d5d-ca42b101c275	2021-02-24	Warnings	Exact identifier application number: M003
Hand Sanitizer Lemon 2oz	ALCOHOL	Ningbo Rejoice International	b0a4159a-cb07-4ce6-e053-2995a90a76e7	2020-10-02	Warnings	Exact identifier application number: M003
Sanix Alcohol Hand Rub	ALCOHOL	Topiderm, Inc	a4fbb714-4f20-400a-ab98-f1c8807ce6fc	2020-03-24	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	419cc9a2-bfde-a516-e063-6294a90a065c	1
310481	gentian violet 10 MG/ML Topical Solution	SCD	419cc9a2-bfde-a516-e063-6294a90a065c	1
310481	gentian violet 1 % Topical Solution	SY	419cc9a2-bfde-a516-e063-6294a90a065c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10095-101-02	10095010102	30 mL in 1 BOTTLE, WITH APPLICATOR (10095-101-02)	30 ml	2025-10-01	No	No	Current