El Valle Gentian Violet

Product NDC
55758-373
11-digit product format
557580373
Labeler code
55758
Product ID
55758-373_4f5ea8bd-610f-3a7f-e063-6394a90af8dd
Type
HUMAN OTC DRUG
Nonproprietary name
Gentian Violet 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-31
Substance
GENTIAN VIOLET
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
El Valle Gentian Violet
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIAN VIOLET10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ4Z741D6O5
Rxcui310481

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-373-01El Valle Gentian Violet30 mL in 1 BOTTLE, PLASTICLIQUID307
55758-373-02El Valle Gentian Violet15 mL in 1 BOTTLE, PLASTICLIQUID157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-373EL VALLE GENTIAN VIOLET (GENTIAN VIOLET 1%) LIQUID [PHARMADEL LLC]5Current NDC, 2 package rows20241120_fc75aa2b-0e6e-e2f7-e053-6294a90ac01f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310481gentian violet 1 % Topical SolutionPSNfc75aa2b-0e6e-e2f7-e053-6294a90ac01f7
310481gentian violet 10 MG/ML Topical SolutionSCDfc75aa2b-0e6e-e2f7-e053-6294a90ac01f7
310481gentian violet 1 % Topical SolutionSYfc75aa2b-0e6e-e2f7-e053-6294a90ac01f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-373-015575803730130 mL in 1 BOTTLE, PLASTIC (55758-373-01) 30 ml2023-05-31NoNoCurrent
55758-373-025575803730215 mL in 1 BOTTLE, PLASTIC15 mlHistorical