FDA.reportPublic FDA data

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
IngredientStrength
GENTIAN VIOLET2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J4Z741D6O5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313997Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-014-02Gentian Violet 2%59.14 mL in 1 BOTTLE, PLASTICSOLUTION59.143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54633-014-02ML - Milliliter54633-0144884732a-fc88-4e16-af9f-31eb44bf42db12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTIAN VIOLETACTIVE INGREDIENTJ4Z741D6O5GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1
GENTIAN VIOLET CATIONACTIVE MOIETY3GVJ31T6YYGENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54633-014GENTIAN VIOLET 2% SOLUTION [THE PODIATREE COMPANY]2Current NDC, Legacy NDC, 1 package rows20171220_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 57 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe8cdf841-cf56-26cc-e053-2995a90aab512025-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLCc17603f2-3548-4225-b611-216c2763e51f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc601d9ea-25ab-cd1d-e053-2995a90ae2522025-10-23WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCardinal Healthcc0a6e1e-ec95-cb48-e053-2a95a90ac0ce2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions, LLCd07d103d-420b-5307-e053-2995a90a14f52025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHtl-Strefa, Inc.d72ddf5a-72e7-c37d-e053-2995a90ad48b2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc92524fd-8b91-592d-e053-2a95a90a88c62025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLCardinal Health89852887-ae62-4277-b615-75663afb54362025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.b9826baa-b976-14c6-e053-2995a90a7d092025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc9261c7f-9f8f-6476-e053-2a95a90a0e932025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLRugby Laboratoriesea28b27a-456e-4042-b769-f060727599332025-10-23WarningsExact identifier
application number: M003
School Health Sterile Alcohol Prep PadISOPROPYL ALCOHOLSchool Health Corporation718640e1-826b-4b65-a021-3f82cd4c983a2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313997gentian violet 2 % Topical SolutionPSN60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b83
313997gentian violet 20 MG/ML Topical SolutionSCD60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b83
313997gentian violet 2 % Topical SolutionSY60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54633-014-025463300140259.14 mL in 1 BOTTLE, PLASTIC (54633-014-02) 59.14 ml2014-10-140000-00-00NoNoCurrent