GENTANX

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: GENTANX
Generic name: MELISSA OFFICINALIS LEAF, THUJA OCCIDENTALIS LEAF, GERANIUM MACULATUM, CALENDULA OFFICINALIS
Manufacturer: Outbreaks, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 33f0f4b8-1aca-4b52-bec3-ded7ac08dcd7
SPL ID: 29f05aaf-89b3-e293-e063-6394a90ad0e5
Version: 2
Effective date: 2025-01-14
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:38:10

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		GENTANX	openfda.brand_name
generic name		MELISSA OFFICINALIS LEAF, THUJA OCCIDENTALIS LEAF, GERANIUM MACULATUM, CALENDULA OFFICINALIS	openfda.generic_name
manufacturer name		Outbreaks, Inc.	openfda.manufacturer_name
ndc	package	83243-002-01	openfda.package_ndc
ndc	product	83243-002	openfda.product_ndc
ndc11	package	83243000201	derived:openfda.package_ndc
spl id		29f05aaf-89b3-e293-e063-6394a90ad0e5	id
spl set id		33f0f4b8-1aca-4b52-bec3-ded7ac08dcd7	set_id
unii		0T0DQN8786	openfda.unii
unii		50D2ZE9219	openfda.unii
unii		93IXI5B6OJ	openfda.unii
unii		P0M7O4Y7YD	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Flammable, keep away from fire or flame. Do not use if you are allergic to any ingredient in this product over large areas of the body When using this product apply only to affected area do not use in or near eyes avoid applying directly inside the vagina or rectum. you may feel a brief burning sensation when you apply it. It should go away in a short time. do not share or reuse an applicator, as spreading or reinfection may occur. do not remove cardboard sleeve after crushing,as cuts from glass may occur. Stop use and ask a doctor if – your symptoms worsen or condition clears up and occurs again within a few days Ask a doctor if – you are pregnant or nursing Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.