NDC 43857-0535 Pollen Mix

American Elm, Plane (sycamore), Ash, Beech, Willow, Elder (box Elder), Alder, Cedar, Maple, Hazel, Poplar, Kentucky Bluegrass, Orchard Grass, Silver Birch, Bermuda Grass, Johnson Grass, Rye Grass, Vernal Grass, Bahia Grass, Oak, Hickory, Timothy Grass

NDC Product Code 43857-0535

NDC CODE: 43857-0535

Proprietary Name: Pollen Mix 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: American Elm, Plane (sycamore), Ash, Beech, Willow, Elder (box Elder), Alder, Cedar, Maple, Hazel, Poplar, Kentucky Bluegrass, Orchard Grass, Silver Birch, Bermuda Grass, Johnson Grass, Rye Grass, Vernal Grass, Bahia Grass, Oak, Hickory, Timothy Grass 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 43857-0535-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Pollen Mix with NDC 43857-0535 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Pollen Mix is american elm, plane (sycamore), ash, beech, willow, elder (box elder), alder, cedar, maple, hazel, poplar, kentucky bluegrass, orchard grass, silver birch, bermuda grass, johnson grass, rye grass, vernal grass, bahia grass, oak, hickory, timothy grass. 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.

Pollen Mix 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.

  • ULMUS AMERICANA POLLEN 16 [hp_X]/mL
  • PLATANUS X ACERIFOLIA POLLEN 16 [hp_X]/mL
  • FRAXINUS EXCELSIOR POLLEN 16 [hp_X]/mL
  • FAGUS SYLVATICA POLLEN 16 [hp_X]/mL
  • SALIX X FRAGILIS POLLEN 16 [hp_X]/mL
  • SAMBUCUS CANADENSIS FLOWER 16 [hp_X]/mL
  • ALNUS RUBRA POLLEN 16 [hp_X]/mL
  • JUNIPERUS VIRGINIANA POLLEN 16 [hp_X]/mL
  • ACER SACCHARUM POLLEN 16 [hp_X]/mL
  • CORYLUS AVELLANA POLLEN 16 [hp_X]/mL
  • POPULUS ALBA POLLEN 16 [hp_X]/mL
  • POA PRATENSIS POLLEN 16 [hp_X]/mL
  • DACTYLIS GLOMERATA POLLEN 16 [hp_X]/mL
  • BETULA PENDULA POLLEN 16 [hp_X]/mL
  • CYNODON DACTYLON POLLEN 16 [hp_X]/mL
  • SORGHUM HALEPENSE POLLEN 16 [hp_X]/mL
  • SECALE CEREALE POLLEN 16 [hp_X]/mL
  • ANTHOXANTHUM ODORATUM POLLEN 16 [hp_X]/mL
  • PASPALUM NOTATUM POLLEN 16 [hp_X]/mL
  • QUERCUS ROBUR POLLEN 16 [hp_X]/mL
  • CARYA GLABRA POLLEN 16 [hp_X]/mL
  • PHLEUM PRATENSE POLLEN 16 [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: 10-29-2019 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.

Pollen Mix Product Label Images

Pollen Mix 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:

American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X.

Indications:

For temporary relief of allergies due to pollen.

For temporary relief of allergies due to pollen.

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*For a complete list of Pollen Allersodes contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalPOLLEN MIXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.