Traulevium

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: Traulevium
Generic name: ARNICA MONTANA RADIX, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.
Manufacturer: Medical Technology Products, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 797f448f-a4c7-4c7a-980d-7c3b074e6499
SPL ID: d44c2b78-496a-70f3-e053-2a95a90a9ffd
Version: 3
Effective date: 2021-12-29
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:18:06

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Traulevium	openfda.brand_name
generic name		ARNICA MONTANA RADIX, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.	openfda.generic_name
manufacturer name		Medical Technology Products, Inc.	openfda.manufacturer_name
ndc	package	70857-001-50	openfda.package_ndc
ndc	product	70857-001	openfda.product_ndc
ndc11	package	70857000150	derived:openfda.package_ndc
spl id		d44c2b78-496a-70f3-e053-2a95a90a9ffd	id
spl set id		797f448f-a4c7-4c7a-980d-7c3b074e6499	set_id
unii		2FXJ6SW4PK	openfda.unii
unii		XK4IUX8MNB	openfda.unii
unii		324Y4038G2	openfda.unii
unii		18E7415PXQ	openfda.unii
unii		2HU33I03UY	openfda.unii
unii		M9VVZ08EKQ	openfda.unii
unii		4N9P6CC1DX	openfda.unii
unii		WQZ3G9PF0H	openfda.unii
unii		QI7G114Y98	openfda.unii
unii		U0NQ8555JD	openfda.unii
unii		G0R4UBI2ZZ	openfda.unii
unii		T7S323PKJS	openfda.unii
unii		1MBW07J51Q	openfda.unii
unii		MUE8Y11327	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 Warnings For external use only. Do not apply over open wounds or broken skin. If symptoms worsen or persist for more than a week, or if a rash develops, a healthcare provider should be consulted. In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to Traulevium or any of its ingredients exists. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, consult a healthcare provider before use. Contraindications: Known allergy (hypersensitivity) to one of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Chamomilla (German chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy) and emulsifying cetylstearyl alcohol. Keep out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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