NDC 43857-0406 Teething

Arnica Montana, Trifolium Pratense, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Chamomilla, Kreosotum, Silicea

NDC Product Code 43857-0406

NDC CODE: 43857-0406

Proprietary Name: Teething 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: Arnica Montana, Trifolium Pratense, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Chamomilla, Kreosotum, Silicea 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 43857-0406-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Teething with NDC 43857-0406 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Teething is arnica montana, trifolium pratense, calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, kreosotum, silicea. 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.

Teething 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.

  • ARNICA MONTANA 3 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL
  • CALCIUM FLUORIDE 12 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/mL
  • MATRICARIA RECUTITA 12 [hp_X]/mL
  • WOOD CREOSOTE 12 [hp_X]/mL
  • SILICON DIOXIDE 12 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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.
  • 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: 07-27-2016 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.

Teething Product Label Images

Teething Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X

Indications:

For temporary relief of pain due to teething and delayed teething.

For temporary relief of pain due to teething and delayed teething.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in cool, dry place.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalTEETHINGHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.