Injury

Product NDC
43857-0404
11-digit product format
438570404
Labeler code
43857
Product ID
43857-0404_ad03f0d7-93aa-4fa4-86e2-7634c6b7d6dd
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana, Calendula Officinalis, Hypericum Perforatum, Symphytum Officinale, Belladonna, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-07-08
Substance
ARNICA MONTANA WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM WHOLE; COMFREY ROOT; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS WHOLE; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM WHOLE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT
Active strength
3; 3; 3; 6; 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; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Injury
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA WHOLE3 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE3 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
ATROPA BELLADONNA WHOLE12 [hp_X]/mL
BELLIS PERENNIS WHOLE12 [hp_X]/mL
ACTIVATED CHARCOAL12 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK12 [hp_X]/mL
ACHILLEA MILLEFOLIUM WHOLE12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]/mL
VERATRUM ALBUM ROOT12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
18E7415PXQInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
DSV74G1P2JInternal UNII lookup
2HU33I03UYInternal UNII lookup
2P3VWU3H10Internal UNII lookup
T7S323PKJSInternal UNII lookup
2FXJ6SW4PKInternal UNII lookup
6IO182RP7AInternal UNII lookup
N94C2U587SInternal UNII lookup
QNS6W5US1ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1189c23-f8a8-47fd-8a5e-e7d29a676188Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0404-1Injury30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0404INJURY (ARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLADONNA, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, Legacy NDC, 1 package rows20160712_a1189c23-f8a8-47fd-8a5e-e7d29a676188.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
InjuryARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLADONNA, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUMBioActive Nutritional, Inc.a1189c23-f8a8-47fd-8a5e-e7d29a6761882026-06-08WarningsExact identifier
ndc (product): 43857-0404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0404-14385704040130 mL in 1 BOTTLE, DROPPER (43857-0404-1) 30 ml2016-07-080000-00-00NoNoCurrent