Traulevium

Product NDC
70857-002
Requested package NDC
70857-002-10
11-digit product format
708570002
Labeler code
70857
Product ID
70857-002_d44bff7e-57cc-a6fa-e053-2a95a90a4e04
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Arnica Montana Radix, Aconitum Napellus, Chamomilla, Symphytum Officinale, Calendula Officinalis, Hamamelis Virginiana, Millefolium, Hepar Sulphuris Calcareum, Mercurius Solubilis, Hypericum Perforatum, Bellis Perennis, Echinacea Angustifolia, Echinacea Purpurea.
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Medical Technology Products, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-10-03
Substance
ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS
Active strength
3; 3; 3; 4; 2; 8; 2; 8; 2; 2; 2; 3; 3; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
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
ATROPA BELLADONNA3 [hp_X]/1
ARNICA MONTANA3 [hp_X]/1
ACONITUM NAPELLUS3 [hp_X]/1
MATRICARIA RECUTITA4 [hp_X]/1
COMFREY ROOT2 [hp_X]/1
CALENDULA OFFICINALIS FLOWERING TOP8 [hp_X]/1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]/1
ACHILLEA MILLEFOLIUM8 [hp_X]/1
CALCIUM SULFIDE2 [hp_X]/1
MERCURIUS SOLUBILIS2 [hp_X]/1
HYPERICUM PERFORATUM2 [hp_X]/1
BELLIS PERENNIS3 [hp_X]/1
ECHINACEA ANGUSTIFOLIA3 [hp_X]/1
ECHINACEA PURPUREA8 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WQZ3G9PF0HInternal UNII lookup
O80TY208ZWInternal UNII lookup
U0NQ8555JDInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
18E7415PXQInternal UNII lookup
T7S323PKJSInternal UNII lookup
2FXJ6SW4PKInternal UNII lookup
1MBW07J51QInternal UNII lookup
324Y4038G2Internal UNII lookup
XK4IUX8MNBInternal UNII lookup
2HU33I03UYInternal UNII lookup
VB06AV5US8Internal UNII lookup
QI7G114Y98Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6123d145-4edf-4ecd-8b30-196e52273127Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70857-002-10Traulevium100 in 1 BOTTLETABLET, CHEWABLE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70857-002TRAULEVIUM (BELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA.) TABLET, CHEWABLE [MEDICAL TECHNOLOGY PRODUCTS, INC.]4Current NDC, Legacy NDC, 1 package rows20211230_6123d145-4edf-4ecd-8b30-196e52273127.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
TrauleviumBELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA.Medical Technology Products, Inc.6123d145-4edf-4ecd-8b30-196e522731272021-12-29WarningsExact identifier
ndc (package): 70857-002-10
ndc (product): 70857-002
ndc11 (package): 70857000210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70857-002-1070857000210100 TABLET, CHEWABLE in 1 BOTTLE (70857-002-10) 2016-10-030000-00-00NoNoCurrent