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 CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; HYPERICUM PERFORATUM WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; STRONTIUM CARBONATE
Active strength 3; 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
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0416-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0416-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0416-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0416-1 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Traumatone Active Ingredients# Ingredient, Strength table Ingredient Strength CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL COMFREY ROOT 6 [hp_X]/mL ARNICA MONTANA WHOLE 12 [hp_X]/mL BELLIS PERENNIS WHOLE 12 [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 UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 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 ndc (product): 44911-0416
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