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 13 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio Glow	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5599605b-28f0-a534-e063-6394a90a7213	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559987c0-7abd-13fc-e063-6294a90a9f27	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY STRAWBERRE HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5740a2ed-e77d-3f41-e063-6394a90aec03	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY VANILLA HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574ba9b9-b44d-b014-e063-6394a90af768	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY COTTON CANDY HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574bcf4f-ad36-5ede-e063-6294a90a0eab	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY COCONUT HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	57539bdd-641d-3c27-e063-6394a90af84a	2026-07-01	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Hudson Health LLC	42789576-0ab4-1afb-e063-6294a90a1d27	2026-06-30	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared Plum	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	5572d336-f953-90ac-e063-6394a90a2d4d	2026-06-30	Warnings	Exact identifier application number: M003
McKesson Alcohol Prep Pad	ISOPROPYL ALCOHOL	McKesson Medical-Surgical	a8e759f3-91b1-44ae-960a-3a6cd4f746ce	2026-06-30	Warnings	Exact identifier application number: M003
Tinted Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	f3c1c8a3-6b34-46cf-845e-c89db8f096f1	2026-06-30	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	a04239d8-0fa9-4c00-aa81-d7a1242bc931	2026-06-30	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	555da50d-f106-f27f-e063-6294a90a61f9	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55601f99-b1a7-ffb5-e063-6394a90a37d6	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556073a0-242b-dc26-e063-6394a90a9ccf	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55709e6c-e2ec-9c16-e063-6394a90a269e	2026-06-29	Warnings	Exact identifier application number: M003
MedPride Alcohol Wipes	ISOPROPYL ALCOHOL	Shield Line LLC	ad2a29b2-0511-bbe4-e053-2a95a90ac0b1	2026-06-29	Warnings	Exact identifier application number: M003
Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Pharma Nobis, LLC	e42df0bf-cce7-3961-e053-2995a90a730a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556f24a7-2294-424f-e063-6394a90a0b68	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556fa2a3-38de-1393-e063-6294a90add6a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556fcd84-0b0d-ed0b-e063-6394a90a45eb	2026-06-29	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