Traumatone

Product NDC
44911-0714
11-digit product format
449110714
Labeler code
44911
Product ID
44911-0714_efa49d66-c818-44b4-918e-fe5487c27957
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Symphytum Officinale, Arnica Montana, Bellis Perennis, Camphora, Hamamelis Virginiana, Hypericum Perforatum, Ledum Palustre, Natrum Sulphuricum, Phosphorus, Rhus Tox, Ruta Graveolens, Staphysagria, Strontium Carbonicum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-08-01
Substance
ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; PHOSPHORUS; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; STRONTIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF
Active strength
12; 12; 3; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]/mL
COMFREY ROOT12 [hp_X]/mL
ARNICA MONTANA WHOLE3 [hp_X]/mL
BELLIS PERENNIS WHOLE12 [hp_X]/mL
CAMPHOR (NATURAL)6 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK12 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE12 [hp_X]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
STRONTIUM CARBONATE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18E7415PXQInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
O80TY208ZWInternal UNII lookup
2HU33I03UYInternal UNII lookup
N20HL7Q941Internal UNII lookup
T7S323PKJSInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
877L01IZ0PInternal UNII lookup
0YPR65R21JInternal UNII lookup
27YLU75U4WInternal UNII lookup
6IO182RP7AInternal UNII lookup
N94C2U587SInternal UNII lookup
00543AP1JVInternal UNII lookup
41YPU4MMCAInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5d5c14e-b54d-49c6-aea4-df79a44d1d8dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0714-1Traumatone30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0714TRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, CAMPHORA, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUM) LIQUID [ENERGIQUE, INC.]1Current NDC, 1 package rows20240802_b5d5c14e-b54d-49c6-aea4-df79a44d1d8d.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
TraumatoneCALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, CAMPHORA, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUMEnergique, Inc.b5d5c14e-b54d-49c6-aea4-df79a44d1d8d2024-08-01WarningsExact identifier
ndc (product): 44911-0714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44911-0714-14491107140130 mL in 1 BOTTLE, DROPPER (44911-0714-1) 30 ml2024-08-01NoNoCurrent