Home NDC 83243-002 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 83243-002 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83243-002 83243-002-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base GENTANX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MELISSA OFFICINALIS LEAF 3 [hp_X]/.5mL THUJA OCCIDENTALIS LEAF 3 [hp_X]/.5mL GERANIUM MACULATUM ROOT 3 [hp_X]/.5mL CALENDULA OFFICINALIS FLOWER 3 [hp_X]/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83243-002-01 GENTANX 0.5 mL in 1 APPLICATOR LIQUID 0.5 2 83243-002-01 GENTANX 9 in 1 PACKAGE LIQUID 9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83243-002 GENTANX (MELISSA OFFICINALIS LEAF, THUJA OCCIDENTALIS LEAF, GERANIUM MACULATUM, CALENDULA OFFICINALIS) LIQUID [OUTBREAKS, INC.] 2 Current NDC, 2 package rows 20250116_33f0f4b8-1aca-4b52-bec3-ded7ac08dcd7.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GENTANX MELISSA OFFICINALIS LEAF, THUJA OCCIDENTALIS LEAF, GERANIUM MACULATUM, CALENDULA OFFICINALIS Outbreaks, Inc. 33f0f4b8-1aca-4b52-bec3-ded7ac08dcd7 2025-01-14 Warnings Exact identifier ndc (product): 83243-002
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83243-002-01 83243000201 9 APPLICATOR in 1 PACKAGE (83243-002-01) / .5 mL in 1 APPLICATOR 9 applicator 2023-09-07 No No Current