Trauma plus Gel

Product NDC
44911-0446
11-digit product format
449110446
Labeler code
44911
Product ID
44911-0446_a953cf42-4285-40cb-a1fe-f84a6b365987
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum
Dosage form
GEL
Route
TOPICAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-02-08
Substance
CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE
Active strength
1; 1; 1; 6; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Trauma plus Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/g
ARNICA MONTANA1 [hp_X]/g
HYPERICUM PERFORATUM1 [hp_X]/g
COMFREY ROOT6 [hp_X]/g
BELLIS PERENNIS12 [hp_X]/g
LEDUM PALUSTRE TWIG12 [hp_X]/g
SULFURIC ACID12 [hp_X]/g
CALCIUM FLUORIDE30 [hp_X]/g
FERROSOFERRIC PHOSPHATE30 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF30 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP30 [hp_X]/g
SODIUM SULFATE30 [hp_C]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18E7415PXQInternal UNII lookup
O80TY208ZWInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
2HU33I03UYInternal UNII lookup
877L01IZ0PInternal UNII lookup
O40UQP6WCFInternal UNII lookup
O3B55K4YKIInternal UNII lookup
91GQH8I5F7Internal UNII lookup
6IO182RP7AInternal UNII lookup
N94C2U587SInternal UNII lookup
0YPR65R21JInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6da04ff9-4088-427c-9757-36092c8f7585Available 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
44911-0446-1Trauma plus Gel57 g in 1 TUBEGEL571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0446TRAUMA PLUS GEL (CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUM) GEL [ENERGIQUE, INC.]1Current NDC, Legacy NDC, 1 package rows20180209_6da04ff9-4088-427c-9757-36092c8f7585.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
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.6da04ff9-4088-427c-9757-36092c8f75852018-02-08WarningsExact identifier
ndc (product): 44911-0446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0446-14491104460157 g in 1 TUBE (44911-0446-1) 57 g2018-02-080000-00-00NoNoCurrent