Injury Topical

Product NDC
43857-0608
11-digit product format
438570608
Labeler code
43857
Product ID
43857-0608_e0b3d28d-6c2a-4c8d-8f38-4ed2f6a393b7
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album
Dosage form
LOTION
Route
TOPICAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-05-13
Substance
ACHILLEA MILLEFOLIUM WHOLE; ACTIVATED CHARCOAL; ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT
Active strength
12; 12; 1; 12; 1; 6; 12; 3; 12; 12; 12 [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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Injury Topical
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACHILLEA MILLEFOLIUM WHOLE12 [hp_X]/g
ACTIVATED CHARCOAL12 [hp_X]/g
ARNICA MONTANA WHOLE1 [hp_X]/g
BELLIS PERENNIS WHOLE12 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/g
COMFREY ROOT6 [hp_X]/g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK12 [hp_X]/g
HYPERICUM PERFORATUM WHOLE3 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/g
VERATRUM ALBUM ROOT12 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FXJ6SW4PK, 2P3VWU3H10, O80TY208ZW, 2HU33I03UY, 18E7415PXQ, M9VVZ08EKQ, T7S323PKJS, XK4IUX8MNB, N94C2U587S, 6IO182RP7A, QNS6W5US1Z

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0608-12024-10-17C16284748780-1f386c64a-05ec-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0608-12023-01-30C16284748780-1f386c64a-05ec-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0608-1Injury Topical57 g in 1 TUBELOTION572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0608INJURY TOPICAL (CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUM) LOTION [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_c5ed8876-d419-41db-9af3-42d76e1c562e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0608-14385706080157 g in 1 TUBE (43857-0608-1) 57 g2021-05-130000-00-00NoNoCurrent