Traulevium

Product NDC
70857-004
11-digit product format
708570004
Labeler code
70857
Product ID
70857-004_d44c63cf-1825-746a-e053-2a95a90adf65
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana, 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
GEL
Route
TOPICAL
Labeler
Medical Technology Products, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-09-19
Substance
ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; 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
.09; 4; 3; 1; .1; 6; .45; 6; .15; .15; .45; 6; .15; 6 g/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; g/100g; [hp_X]/100g; g/100g; [hp_X]/100g; g/100g; g/100g; g/100g; [hp_X]/100g; g/100g; [hp_X]/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Traulevium
Brand name suffix
Pain Relief Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA.09 g/100g
CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]/100g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]/100g
ECHINACEA, UNSPECIFIED1 [hp_X]/100g
ECHINACEA PURPUREA.1 g/100g
MATRICARIA RECUTITA6 [hp_X]/100g
COMFREY ROOT.45 g/100g
BELLIS PERENNIS6 [hp_X]/100g
HYPERICUM PERFORATUM.15 g/100g
ACHILLEA MILLEFOLIUM.15 g/100g
ACONITUM NAPELLUS.45 g/100g
ATROPA BELLADONNA6 [hp_X]/100g
MERCURIUS SOLUBILIS.15 g/100g
CALCIUM SULFIDE6 [hp_X]/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal 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
692daf7a-11e2-4f08-bdcf-1b9ac866d213Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70857-004-16TrauleviumPain Relief Gel454 g in 1 BOTTLE, PUMPGEL4545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70857-004TRAULEVIUM PAIN RELIEF GEL (ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.) GEL [MEDICAL TECHNOLOGY PRODUCTS, INC.]5Current NDC, Legacy NDC, 1 package rows20211230_692daf7a-11e2-4f08-bdcf-1b9ac866d213.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
Traulevium Pain Relief GelARNICA MONTANA, 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.692daf7a-11e2-4f08-bdcf-1b9ac866d2132021-12-29WarningsExact identifier
ndc (product): 70857-004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70857-004-1670857000416454 g in 1 BOTTLE, PUMP (70857-004-16) 454 g2016-09-190000-00-00NoNoCurrent