Traumatone

Product NDC: 44911-0416
Requested package NDC: 44911-0416-1
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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
18E7415PXQ	Internal UNII lookup
M9VVZ08EKQ	Internal UNII lookup
O80TY208ZW	Internal UNII lookup
2HU33I03UY	Internal UNII lookup
XK4IUX8MNB	Internal UNII lookup
877L01IZ0P	Internal UNII lookup
27YLU75U4W	Internal UNII lookup
6IO182RP7A	Internal UNII lookup
N94C2U587S	Internal UNII lookup
00543AP1JV	Internal UNII lookup
41YPU4MMCA	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d4e72b3a-7336-410d-99e3-df10bcc65e75	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-08-01	Drug Facts:
2024-01-30	Drug Facts:
2022-03-15	Drug Facts:
2022-01-28	Drug Facts:

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 (package): 44911-0416-1 ndc (product): 44911-0416 ndc11 (package): 44911041601

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
18E7415PXQ	CALENDULA OFFICINALIS FLOWERING TOP		CALENDULA OFFICINALIS FLOWERING TOP
M9VVZ08EKQ	COMFREY ROOT		COMFREY ROOT
877L01IZ0P	RHODODENDRON TOMENTOSUM LEAFY TWIG		RHODODENDRON TOMENTOSUM LEAFY TWIG
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
6IO182RP7A	TOXICODENDRON PUBESCENS LEAF		TOXICODENDRON PUBESCENS LEAF
N94C2U587S	RUTA GRAVEOLENS FLOWERING TOP		RUTA GRAVEOLENS FLOWERING TOP
00543AP1JV	DELPHINIUM STAPHISAGRIA SEED		DELPHINIUM STAPHISAGRIA SEED
41YPU4MMCA	STRONTIUM CARBONATE	1633-05-2	STRONTIUM CARBONATE

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