Home NDC 43857-0539 Ear
Product NDC 43857-0539
11-digit product format 438570539
Labeler code 43857
Product ID 43857-0539_64379f2e-0201-42b6-924d-a8d1ee244531
Type HUMAN OTC DRUG
Nonproprietary name Baptisia Tinctoria, Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (Pratensis)
Dosage form LIQUID
Route ORAL
Labeler BioActive Nutritional, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-10-24
Substance BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA ANGUSTIFOLIA WHOLE; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; MATRICARIA CHAMOMILLA WHOLE; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR WHOLE; POTASSIUM CHLORIDE; PULSATILLA PRATENSIS WHOLE
Active strength 3; 12; 3; 12; 5; 12; 4; 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
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 8 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43857-0539-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43857-0539-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43857-0539-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43857-0539-1 8dfbde2a14a4…c9ff85d89658…
Additional Listing Data#
Finished product Yes
Brand name base Ear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE 12 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL GOLDENSEAL 12 [hp_X]/mL CAPSICUM 5 [hp_X]/mL MATRICARIA CHAMOMILLA WHOLE 12 [hp_X]/mL FERROSOFERRIC PHOSPHATE 4 [hp_X]/mL POTASSIUM CHLORIDE 12 [hp_X]/mL PLANTAGO MAJOR WHOLE 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43857-0539-1 Ear 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0539 EAR (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240106_82774eed-a906-4a19-86d9-05ea1462bd61.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 Ear BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS) BioActive Nutritional, Inc. 82774eed-a906-4a19-86d9-05ea1462bd61 2026-03-18 Warnings Exact identifier ndc (product): 43857-0539
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43857-0539-1 43857053901 30 mL in 1 BOTTLE, DROPPER (43857-0539-1) 30 ml 2019-10-24 No No Current