Pollen Mix

Alfalfa, American Elm, Sycamore, Ash, Beech, Black Walnut, Black Willow, Box Elder, Eastern Cottonwood, False Ragweed, Giant Ragweed, Goldenrod, Kentucky Bluegrass, Orchard Grass, Red Birch, Red Clover, Red Oak, Redtop Grass, Hickory, Sheep Sorrel, Short Ragweed, Timothy Grass, Western Ragweed, Yellow Dock

Bioactive Nutritional, Inc.
Human Otc Drug
NDC 43857-0007

Pollen Mix also known as Alfalfa, American Elm, Sycamore, Ash, Beech, Black Walnut, Black Willow, Box Elder, Eastern Cottonwood, False Ragweed, Giant Ragweed, Goldenrod, Kentucky Bluegrass, Orchard Grass, Red Birch, Red Clover, Red Oak, Redtop Grass, Hickory, Sheep Sorrel, Short Ragweed, Timothy Grass, Western Ragweed, Yellow Dock is a human otc drug labeled by 'Bioactive Nutritional, Inc.'. National Drug Code (NDC) number for Pollen Mix is 43857-0007. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Pollen Mix drug includes Acer Negundo Pollen - 9 [hp_X]/mL Agrostis Gigantea Top - 9 [hp_X]/mL Alfalfa - 9 [hp_X]/mL Ambrosia Acanthicarpa Pollen - 9 [hp_X]/mL Ambrosia Artemisiifolia - 9 [hp_X]/mL Ambrosia Psilostachya Top - 9 [hp_X]/mL Ambrosia Trifida Pollen - 9 [hp_X]/mL Betula Occidentalis Pollen - 9 [hp_X]/mL Carya Ovata Pollen - 9 [hp_X]/mL Dactylis Glomerata Top - 9 [hp_X]/mL and more. The currest status of Pollen Mix drug is Active.

Drug Information:

Drug NDC:	43857-0007
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Pollen Mix
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Alfalfa, American Elm, Sycamore, Ash, Beech, Black Walnut, Black Willow, Box Elder, Eastern Cottonwood, False Ragweed, Giant Ragweed, Goldenrod, Kentucky Bluegrass, Orchard Grass, Red Birch, Red Clover, Red Oak, Redtop Grass, Hickory, Sheep Sorrel, Short Ragweed, Timothy Grass, Western Ragweed, Yellow Dock
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bioactive Nutritional, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACER NEGUNDO POLLEN - 9 [hp_X]/mL AGROSTIS GIGANTEA TOP - 9 [hp_X]/mL ALFALFA - 9 [hp_X]/mL AMBROSIA ACANTHICARPA POLLEN - 9 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA - 9 [hp_X]/mL AMBROSIA PSILOSTACHYA TOP - 9 [hp_X]/mL AMBROSIA TRIFIDA POLLEN - 9 [hp_X]/mL BETULA OCCIDENTALIS POLLEN - 9 [hp_X]/mL CARYA OVATA POLLEN - 9 [hp_X]/mL DACTYLIS GLOMERATA TOP - 9 [hp_X]/mL Load more... FAGUS GRANDIFOLIA POLLEN - 9 [hp_X]/mL FRAXINUS AMERICANA POLLEN - 9 [hp_X]/mL JUGLANS NIGRA POLLEN - 9 [hp_X]/mL PHLEUM PRATENSE TOP - 9 [hp_X]/mL PLATANUS OCCIDENTALIS POLLEN - 9 [hp_X]/mL POA PRATENSIS TOP - 9 [hp_X]/mL POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN - 9 [hp_X]/mL QUERCUS RUBRA POLLEN - 9 [hp_X]/mL RUMEX ACETOSELLA POLLEN - 9 [hp_X]/mL RUMEX CRISPUS TOP - 9 [hp_X]/mL SALIX NIGRA POLLEN - 9 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 9 [hp_X]/mL TRIFOLIUM PRATENSE FLOWER - 9 [hp_X]/mL ULMUS AMERICANA POLLEN - 9 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	14 Jan, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	06 Mar, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	09 May, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	BioActive Nutritional, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185367 N0000175629 N0000184306 N0000185001 M0017130 M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	P6K070AR8V A5ODF78EPD DJO934BRBD U2AI3H2J5Y 9W34L2CQ9A 3WIG5E69QL KU1V1898XX R889N2L976 54UN9R2798 J41552QKAK Load more... 34X886W1H4 G684LX721Q 1BV28146ZR S7PW24BX20 E03U1K03LK 7EA48700V9 476DVV63WP SVW19ET93C N52MIQ81ZW S9T422Q956 6M2JIH93ZN 5405K23S50 4JS0838828 89BAT511BD
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Non-Standardized Pollen Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Pollen [CS] Allergens [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Pollen Allergenic Extract [EPC] Pollen [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
43857-0007-1	30 mL in 1 BOTTLE, DROPPER (43857-0007-1)	06 Apr, 2016	06 Mar, 2024	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Pollen Mix

Alfalfa & more..

Liquid
BioActive Nutritional, Inc.
NDC: 43857-0007

Purpose:

Indications: for temporary relief of allergies due to pollen.

Product Elements:

Pollen mix alfalfa, american elm, sycamore, ash, beech, black walnut, black willow, box elder, eastern cottonwood, false ragweed, giant ragweed, goldenrod, kentucky bluegrass, orchard grass, red birch, red clover, red oak, redtop grass, hickory, sheep sorrel, short ragweed, timothy grass, western ragweed, yellow dock alfalfa alfalfa ulmus americana pollen ulmus americana pollen platanus occidentalis pollen platanus occidentalis pollen fraxinus americana pollen fraxinus americana pollen fagus grandifolia pollen fagus grandifolia pollen juglans nigra pollen juglans nigra pollen salix nigra pollen salix nigra bark acer negundo pollen acer negundo pollen populus deltoides subsp. deltoides pollen populus deltoides pollen ambrosia acanthicarpa pollen ambrosia acanthicarpa pollen ambrosia trifida pollen ambrosia trifida pollen solidago virgaurea flowering top solidago virgaurea flowering top poa pratensis top poa pratensis top dactylis glomerata top dactylis glomerata top betula occidentalis pollen betula occidentalis pollen trifolium pratense flower trifolium pratense flower quercus rubra pollen quercus rubra pollen agrostis gigantea top agrostis gigantea top carya ovata pollen carya ovata pollen rumex acetosella pollen rumex acetosella pollen ambrosia artemisiifolia ambrosia artemisiifolia phleum pratense top phleum pratense top ambrosia psilostachya top ambrosia psilostachya top rumex crispus top rumex crispus top water alcohol

Indications and Usage:

Indications: for temporary relief of allergies due to pollen.

Warnings:

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.

Dosage and Administration:

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

Package Label Principal Display Panel:

Package label display: bio active nutritional pollen mix homeopathic 1 fl oz (30 ml) pollen mix

Further Questions:

Questions: distributed by: bioactive nutritional, inc. 1803 n. wickham rd. melbourne, fl 32935 bioactivenutritional.com *for a complete list of pollen allersodes contact bioactive nutritional, inc.

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.