ear

Generic: baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (pratensis)

Labeler: bioactive nutritional, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name ear
Generic Name baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (pratensis)
Labeler bioactive nutritional, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

baptisia tinctoria root 3 [hp_X]/mL, capsicum 12 [hp_X]/mL, echinacea angustifolia whole 3 [hp_X]/mL, ferrosoferric phosphate 12 [hp_X]/mL, goldenseal 5 [hp_X]/mL, matricaria chamomilla whole 12 [hp_X]/mL, phytolacca americana root 4 [hp_X]/mL, plantago major whole 12 [hp_X]/mL, potassium chloride 12 [hp_X]/mL, pulsatilla pratensis whole 12 [hp_X]/mL

Manufacturer
BioActive Nutritional, Inc.

Identifiers & Regulatory

Product NDC 43857-0539
Product ID 43857-0539_203fdd03-48d8-4ef0-ae5f-8e0f38c8e900
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2019-10-24

Pharmacologic Class

Established (EPC)
non-standardized plant allergenic extract [epc] non-standardized food allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs] vegetable proteins [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 438570539
Hyphenated Format 43857-0539

Supplemental Identifiers

UNII
5EF0HWI5WU 00UK7646FG VB06AV5US8 91GQH8I5F7 ZW3Z11D0JV G0R4UBI2ZZ 11E6VI8VEG W2469WNO6U 660YQ98I10 8E272251DI
NUI
N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ear (source: ndc)
Generic Name baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (pratensis) (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 [hp_X]/mL
  • 12 [hp_X]/mL
  • 5 [hp_X]/mL
  • 4 [hp_X]/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (43857-0539-1)
source: ndc

Packages (1)

43857-0539-1 30 mL in 1 BOTTLE, DROPPER (43857-0539-1)

Ingredients (10)

baptisia tinctoria root (3 [hp_X]/mL) capsicum (12 [hp_X]/mL) echinacea angustifolia whole (3 [hp_X]/mL) ferrosoferric phosphate (12 [hp_X]/mL) goldenseal (5 [hp_X]/mL) matricaria chamomilla whole (12 [hp_X]/mL) phytolacca americana root (4 [hp_X]/mL) plantago major whole (12 [hp_X]/mL) potassium chloride (12 [hp_X]/mL) pulsatilla pratensis whole (12 [hp_X]/mL)

Linked Drug Pages (1)

Ear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "203fdd03-48d8-4ef0-ae5f-8e0f38c8e900", "openfda": {"nui": ["N0000185375", "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0022575"], "unii": ["5EF0HWI5WU", "00UK7646FG", "VB06AV5US8", "91GQH8I5F7", "ZW3Z11D0JV", "G0R4UBI2ZZ", "11E6VI8VEG", "W2469WNO6U", "660YQ98I10", "8E272251DI"], "spl_set_id": ["82774eed-a906-4a19-86d9-05ea1462bd61"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Vegetable Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Plant Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]"], "manufacturer_name": ["BioActive Nutritional, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (43857-0539-1)", "package_ndc": "43857-0539-1", "marketing_start_date": "20191024"}], "brand_name": "Ear", "product_id": "43857-0539_203fdd03-48d8-4ef0-ae5f-8e0f38c8e900", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "43857-0539", "generic_name": "Baptisia Tinctoria, Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (Pratensis)", "labeler_name": "BioActive Nutritional, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ear", "active_ingredients": [{"name": "BAPTISIA TINCTORIA ROOT", "strength": "3 [hp_X]/mL"}, {"name": "CAPSICUM", "strength": "12 [hp_X]/mL"}, {"name": "ECHINACEA ANGUSTIFOLIA WHOLE", "strength": "3 [hp_X]/mL"}, {"name": "FERROSOFERRIC PHOSPHATE", "strength": "12 [hp_X]/mL"}, {"name": "GOLDENSEAL", "strength": "5 [hp_X]/mL"}, {"name": "MATRICARIA CHAMOMILLA WHOLE", "strength": "12 [hp_X]/mL"}, {"name": "PHYTOLACCA AMERICANA ROOT", "strength": "4 [hp_X]/mL"}, {"name": "PLANTAGO MAJOR WHOLE", "strength": "12 [hp_X]/mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "12 [hp_X]/mL"}, {"name": "PULSATILLA PRATENSIS WHOLE", "strength": "12 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20191024", "listing_expiration_date": "20261231"}