Home NDC 44911-0416 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Traumatone CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUM Energique, Inc. d4e72b3a-7336-410d-99e3-df10bcc65e75 2024-08-01 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS: If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Additional Listing Data#
Finished product Yes
Brand name base Traumatone Active Ingredients# Ingredient, Strength table Ingredient Strength CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X]/mL COMFREY ROOT 12 [hp_X]/mL ARNICA MONTANA WHOLE 3 [hp_X]/mL BELLIS PERENNIS WHOLE 6 [hp_X]/mL HYPERICUM PERFORATUM WHOLE 12 [hp_X]/mL RHODODENDRON TOMENTOSUM LEAFY TWIG 12 [hp_X]/mL PHOSPHORUS 12 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF 12 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/mL STRONTIUM CARBONATE 12 [hp_X]/mL
Harmonized Identifiers# Field, Values table Field Values Unii 18E7415PXQ, M9VVZ08EKQ, O80TY208ZW, 2HU33I03UY, XK4IUX8MNB, 877L01IZ0P, 27YLU75U4W, 6IO182RP7A, N94C2U587S, 00543AP1JV, 41YPU4MMCA
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0416-1 Traumatone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0416 TRAUMATONE (CALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, STAPHYSAGRIA, STRONTIUM CARBONICUM) LIQUID [ENERGIQUE, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240802_d4e72b3a-7336-410d-99e3-df10bcc65e75.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0416-1 44911041601 30 mL in 1 BOTTLE, DROPPER (44911-0416-1) 30 ml 2017-02-08 2027-08-30 No No Current