Home NDC 53499-7290 Triflora
Product NDC 53499-7290
11-digit product format 534997290
Labeler code 53499
Product ID 53499-7290_be615942-cb86-4d3d-8177-efc815ac4ff8
Type HUMAN OTC DRUG
Nonproprietary name Urtica doicia, Rhus Toxicodendron, Ledum Palustre
Dosage form GEL
Route TOPICAL
Labeler Schwabe North America, Inc
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-10-01
Substance LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA
Active strength 2; 4; 1 [hp_X]/77g; [hp_X]/77g; [hp_X]/77g
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 · 1 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53499-7290 53499-7290-4 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Additional Listing Data#
Finished product Yes
Brand name base Triflora
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URTICA DIOICA 2 [hp_X]/77g TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/77g LEDUM PALUSTRE TWIG 1 [hp_X]/77g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 710FLW4U46 Internal UNII lookup 6IO182RP7A Internal UNII lookup 877L01IZ0P Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-7290 TRIFLORA (URTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRE) GEL [SCHWABE NORTH AMERICA, INC] 4 Current NDC, Legacy NDC, 4 package rows 20241215_0f7796ae-a20e-431f-bdec-bca7415b468f.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 Triflora URTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRE Schwabe North America, Inc 0f7796ae-a20e-431f-bdec-bca7415b468f 2025-11-18 Warnings Exact identifier ndc (product): 53499-7290
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53499-7290-4 53499729004 1 TUBE in 1 CARTON (53499-7290-4) > 28 g in 1 TUBE 1 tube 2021-10-01 0000-00-00 No No Current 53499-7290-8 53499729008 1 TUBE in 1 CARTON (53499-7290-8) / 77 g in 1 TUBE 1 tube 2021-10-01 0000-00-00 No No Current