FDA.reportPublic FDA data

Gentian Violet 1%

Product NDC
82645-917
11-digit product format
826450917
Labeler code
82645
Product ID
82645-917_5634adec-3709-bcdf-e063-6394a90ae5a2
Type
HUMAN OTC DRUG
Nonproprietary name
Gentian Violet 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Marketing end
2029-02-01
Substance
GENTIAN VIOLET
Active strength
10 mg/mL
NDC exclude flag
No
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 1%

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIAN VIOLET10 mg/mL

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
310481Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42fa7d2-47ef-0e82-e053-2995a90a67c5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-917-91Gentian Violet 1%30 mL in 1 BOTTLE, PLASTICLIQUID302
82645-917-92Gentian Violet 1%59 mL in 1 BOTTLE, PLASTICLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-917GENTIAN VIOLET 1% LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 2 package rows20231227_e42fa7d2-47ef-0e82-e053-2995a90a67c5.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 84 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLWalgreens78ed5594-433a-4f90-ad39-51e2a7dd2e212025-02-21WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLWalgreens9effa6c9-020d-4a2d-ad26-449d4119b6a02025-02-21WarningsExact identifier
application number: M003
Isopropyl alcohol 50 percent Wintergreen ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCf9ff67b0-c4ad-4162-b3ef-27a85ed0da252025-02-18WarningsExact identifier
application number: M003
Inverness Home Ear Piercing KitBENZALKONIUM CHLORIDEThe Richline Group, Inc.80909a34-21da-4c54-bb62-fd986fd24b042025-02-17WarningsExact identifier
application number: M003
Inverness EAR CARE ANTISEPTICBENZALKONIUM CHLORIDEThe Richline Groupac42d2f1-69e3-45f6-8002-d45ebed5ee222025-02-17WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1507f1-a88f-4ef8-e063-6294a90a92fd2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e159f8f-352c-45ca-e063-6394a90adf9b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1633f1-4b59-6eea-e063-6294a90ae61b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Spider man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e16c9bc-223d-0c65-e063-6294a90a48152025-02-14WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.3007da5f-e2ea-4f3a-905c-770782da014e2025-02-14WarningsExact identifier
application number: M003
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Lemon IceETHYL ALCOHOLNingbo Rejoice Internationala266624f-2175-2fd4-e053-2995a90a33052025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.ETHYL ALCOHOLNingbo Rejoice Internationala2677a83-8f9a-7470-e053-2a95a90aa2892025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala2695f96-ef8c-bba6-e053-2a95a90a243e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 1.8 ozETHYL ALCOHOLNingbo Rejoice Internationala26a866a-bb5f-4b5f-e053-2995a90a97452025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala269e72d-c74b-71ed-e053-2995a90ac1472025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala269a222-95cb-098c-e053-2995a90a21e72025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala346ebd2-fc31-b574-e053-2995a90a0d3a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala7364361-f8ad-fc71-e053-2995a90a68a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala73698ca-2097-3f7d-e053-2a95a90a638a2025-02-13WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310481gentian violet 1 % Topical SolutionPSNe42fa7d2-47ef-0e82-e053-2995a90a67c52
310481gentian violet 10 MG/ML Topical SolutionSCDe42fa7d2-47ef-0e82-e053-2995a90a67c52
310481gentian violet 1 % Topical SolutionSYe42fa7d2-47ef-0e82-e053-2995a90a67c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-917-918264509179130 mL in 1 BOTTLE, PLASTIC (82645-917-91) 30 ml2017-11-132028-04-01NoNoCurrent
82645-917-928264509179259 mL in 1 BOTTLE, PLASTIC (82645-917-92) 59 ml2017-11-132029-02-01NoNoCurrent