FDA.reportPublic FDA data

Traumatone

Product NDC
44911-0416
11-digit product format
449110416
Labeler code
44911
Product ID
44911-0416_9df727b1-265a-48e3-ad50-feee3a962f3e
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Symphytum Officinale, Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Phosphorus, Rhus Tox, Ruta Graveolens, Staphysagria, Strontium Carbonicum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-02-08
Marketing end
2027-08-30
Substance
ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM WHOLE; PHOSPHORUS; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; STRONTIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF
Active strength
12; 12; 3; 6; 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
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Traumatone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA WHOLE12 [hp_X]/mL
BELLIS PERENNIS WHOLE12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]/mL
STRONTIUM CARBONATE12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, 2HU33I03UY, 18E7415PXQ, M9VVZ08EKQ, 00543AP1JV, XK4IUX8MNB, 27YLU75U4W, 877L01IZ0P, N94C2U587S, 41YPU4MMCA, 6IO182RP7A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0416-12024-08-01C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:
44911-0416-12024-01-30C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:
44911-0416-12022-03-15C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:
44911-0416-12022-01-28C16284748780-1d6a99b39-fdd4-a426-e053-dadaa90af4c2Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0416-1Traumatone30 mL in 1 BOTTLE, DROPPERLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0416TRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUM) LIQUID [ENERGIQUE, INC.]6Current NDC, Legacy NDC, 1 package rows20240802_d4e72b3a-7336-410d-99e3-df10bcc65e75.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0416-14491104160130 mL in 1 BOTTLE, DROPPER (44911-0416-1) 30 ml2017-02-082027-08-30NoNoCurrent