Traulevium

Product NDC
70857-001
11-digit product format
708570001
Labeler code
70857
Product ID
70857-001_d44c2b78-496a-70f3-e053-2a95a90a9ffd
Type
HUMAN OTC DRUG
Nonproprietary 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.
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medical Technology Products, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-10-12
Substance
ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS
Active strength
45; 4; 3; 1; 50; 6; 225; 6; 75; 75; 225; 6; 75; 6 mg/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; mg/50g; [hp_X]/50g; mg/50g; [hp_X]/50g; mg/50g; mg/50g; mg/50g; [hp_X]/50g; mg/50g; [hp_X]/50g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Traulevium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA ROOT3 [hp_X]/50g
CALENDULA OFFICINALIS FLOWERING TOP225 mg/50g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK225 mg/50g
ECHINACEA, UNSPECIFIED75 mg/50g
ECHINACEA PURPUREA75 mg/50g
MATRICARIA RECUTITA75 mg/50g
COMFREY ROOT6 [hp_X]/50g
BELLIS PERENNIS50 mg/50g
HYPERICUM PERFORATUM6 [hp_X]/50g
ACHILLEA MILLEFOLIUM45 mg/50g
ACONITUM NAPELLUS4 [hp_X]/50g
ATROPA BELLADONNA1 [hp_X]/50g
MERCURIUS SOLUBILIS6 [hp_X]/50g
CALCIUM SULFIDE6 [hp_X]/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MUE8Y11327Internal UNII lookup
18E7415PXQInternal UNII lookup
T7S323PKJSInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
QI7G114Y98Internal UNII lookup
G0R4UBI2ZZInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
2HU33I03UYInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
2FXJ6SW4PKInternal UNII lookup
U0NQ8555JDInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
324Y4038G2Internal UNII lookup
1MBW07J51QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797f448f-a4c7-4c7a-980d-7c3b074e6499Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70857-001-50Traulevium50 g in 1 TUBEOINTMENT503
70857-001-50Traulevium1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70857-001TRAULEVIUM (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.) OINTMENT [MEDICAL TECHNOLOGY PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20211230_797f448f-a4c7-4c7a-980d-7c3b074e6499.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrauleviumARNICA 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.Medical Technology Products, Inc.797f448f-a4c7-4c7a-980d-7c3b074e64992021-12-29WarningsExact identifier
ndc (product): 70857-001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70857-001-50708570001501 TUBE in 1 BOX (70857-001-50) / 50 g in 1 TUBE1 tube2016-10-120000-00-00NoNoCurrent