Home NDC 43857-0608 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Injury Topical CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUM BioActive Nutritional, Inc. c5ed8876-d419-41db-9af3-42d76e1c562e 2024-10-17 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place. For External Use Only.
Additional Listing Data#
Finished product Yes
Brand name base Injury Topical
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X]/g ARNICA MONTANA WHOLE 12 [hp_X]/g HYPERICUM PERFORATUM WHOLE 1 [hp_X]/g COMFREY ROOT 12 [hp_X]/g BELLIS PERENNIS WHOLE 1 [hp_X]/g ACTIVATED CHARCOAL 6 [hp_X]/g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 12 [hp_X]/g ACHILLEA MILLEFOLIUM WHOLE 3 [hp_X]/g TOXICODENDRON PUBESCENS LEAF 12 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X]/g VERATRUM ALBUM ROOT 12 [hp_X]/g
Harmonized Identifiers# Field, Values table Field Values Unii 18E7415PXQ, O80TY208ZW, XK4IUX8MNB, M9VVZ08EKQ, 2HU33I03UY, 2P3VWU3H10, T7S323PKJS, 2FXJ6SW4PK, 6IO182RP7A, N94C2U587S, QNS6W5US1Z
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43857-0608-1 Injury Topical 57 g in 1 TUBE LOTION 57 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0608 INJURY 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.] 2 Current NDC, Legacy NDC, 1 package rows 20241019_c5ed8876-d419-41db-9af3-42d76e1c562e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43857-0608-1 43857060801 57 g in 1 TUBE (43857-0608-1) 57 g 2021-05-13 0000-00-00 No No Current