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 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43857-0608-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43857-0608-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43857-0608-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43857-0608-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43857-0608-1 1332a3947898…d4bfe170f9cd…
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 UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 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 ndc (product): 43857-0608
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