Home NDC 59469-309 ITIRES
Product NDC 59469-309
11-digit product format 594690309
Labeler code 59469
Product ID 59469-309_d5273f5c-c438-4f63-b7a6-fc209c1ff1c4
Type HUMAN OTC DRUG
Nonproprietary name Arnica montana Root, CALCIUM FLUORIDE, CALCIUM IODIDE, Clematis recta Flowering Top, Scrophularia nodosa, Conium maculatum Flowering Top, HORSE CHESTNUT, and Hedera helix Flowering Twig
Dosage form OINTMENT
Route CUTANEOUS
Labeler PEKANA Naturheilmittel GmbH
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-06-24
Substance ARNICA MONTANA ROOT; CALCIUM FLUORIDE; CALCIUM IODIDE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HORSE CHESTNUT; SCROPHULARIA NODOSA WHOLE
Active strength 8; 8; 6; 4; 6; 6; 4; 2 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ITIRES
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARNICA MONTANA ROOT 8 [hp_X]/35g CALCIUM FLUORIDE 8 [hp_X]/35g CALCIUM IODIDE 6 [hp_X]/35g CLEMATIS RECTA FLOWERING TOP 4 [hp_X]/35g SCROPHULARIA NODOSA WHOLE 6 [hp_X]/35g CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/35g HORSE CHESTNUT 4 [hp_X]/35g HEDERA HELIX FLOWERING TWIG 2 [hp_X]/35g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59469-309-30 ITIRES 30 g in 1 TUBE OINTMENT 30 3 59469-309-30 ITIRES 1 in 1 BOX OINTMENT 1 3 59469-309-35 ITIRES 35 g in 1 TUBE OINTMENT 35 3 59469-309-35 ITIRES 1 in 1 BOX OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59469-309 ITIRES (ARNICA MONTANA ROOT, CALCIUM FLUORIDE, CALCIUM IODIDE, CLEMATIS RECTA FLOWERING TOP, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, HORSE CHESTNUT, AND HEDERA HELIX FLOWERING TWIG) OINTMENT [PEKANA NATURHEILMITTEL GMBH] 3 Current NDC, Legacy NDC, 4 package rows 20221224_8d93bb65-8021-4ef2-87a8-ee90ebd7dc06.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 ITIRES ARNICA MONTANA ROOT, CALCIUM FLUORIDE, CALCIUM IODIDE, CLEMATIS RECTA FLOWERING TOP, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, HORSE CHESTNUT, AND HEDERA HELIX FLOWERING TWIG PEKANA Naturheilmittel GmbH 8d93bb65-8021-4ef2-87a8-ee90ebd7dc06 2022-12-23 Warnings Exact identifier ndc (product): 59469-309
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59469-309-30 59469030930 1 TUBE in 1 BOX (59469-309-30) / 30 g in 1 TUBE 1 tube 2019-06-24 0000-00-00 No No Current 59469-309-35 59469030935 1 TUBE in 1 BOX (59469-309-35) / 35 g in 1 TUBE 1 tube 2019-06-24 0000-00-00 No No Current