NDC 43857-0539 Ear

Baptisia Tinctoria, Echinacea (angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (pratensis)

NDC Product Code 43857-0539

NDC Code: 43857-0539

Proprietary Name: Ear What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Baptisia Tinctoria, Echinacea (angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (pratensis) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0539-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ear with NDC 43857-0539 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Ear is baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (pratensis). The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ear Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 4 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • CAPSICUM 12 [hp_X]/mL
  • MATRICARIA RECUTITA 12 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL
  • POTASSIUM CHLORIDE 12 [hp_X]/mL
  • PLANTAGO MAJOR 12 [hp_X]/mL
  • ANEMONE PRATENSIS 12 [hp_X]/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-24-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ear Product Label Images