FDA.reportPublic FDA data

GENTANX

Product NDC
83243-002
11-digit product format
832430002
Labeler code
83243
Product ID
83243-002_29f05aaf-89b3-e293-e063-6394a90ad0e5
Type
HUMAN OTC DRUG
Nonproprietary name
melissa officinalis leaf, thuja occidentalis leaf, geranium maculatum, calendula officinalis
Dosage form
LIQUID
Route
TOPICAL
Labeler
Outbreaks, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-09-07
Substance
CALENDULA OFFICINALIS FLOWER; GERANIUM MACULATUM ROOT; MELISSA OFFICINALIS LEAF; THUJA OCCIDENTALIS LEAF
Active strength
3; 3; 3; 3 [hp_X]/.5mL; [hp_X]/.5mL; [hp_X]/.5mL; [hp_X]/.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GENTANX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWER3 [hp_X]/.5mL
GERANIUM MACULATUM ROOT3 [hp_X]/.5mL
MELISSA OFFICINALIS LEAF3 [hp_X]/.5mL
THUJA OCCIDENTALIS LEAF3 [hp_X]/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP0M7O4Y7YD, 93IXI5B6OJ, 50D2ZE9219, 0T0DQN8786

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83243-002-01GENTANX0.5 mL in 1 APPLICATORLIQUID0.52
83243-002-01GENTANX9 in 1 PACKAGELIQUID92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83243-002GENTANX (MELISSA OFFICINALIS LEAF, THUJA OCCIDENTALIS LEAF, GERANIUM MACULATUM, CALENDULA OFFICINALIS) LIQUID [OUTBREAKS, INC.]2Current NDC, 2 package rows20250116_33f0f4b8-1aca-4b52-bec3-ded7ac08dcd7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83243-002-01832430002019 APPLICATOR in 1 PACKAGE (83243-002-01) / .5 mL in 1 APPLICATOR9 applicator2023-09-07NoNoCurrent