NDC 43857-0223 Dairy Antigens

American Cheese, Blue Cheese, Brie Cheese, Cheddar Cheese, Cottage Cheese, Swiss Cheese, Lac Vaccinum, Goat Milk, Calcarea Carbonica, Lac Defloratum, Sepia, Sulphur

NDC Product Code 43857-0223

NDC Code: 43857-0223

Proprietary Name: Dairy Antigens 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 Cheese, Blue Cheese, Brie Cheese, Cheddar Cheese, Cottage Cheese, Swiss Cheese, Lac Vaccinum, Goat Milk, Calcarea Carbonica, Lac Defloratum, Sepia, Sulphur 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
    • 43857-0223 - Dairy Antigens

NDC 43857-0223-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Dairy Antigens with NDC 43857-0223 is a a human over the counter drug product labeled by Bioactive Nutritional. The generic name of Dairy Antigens is american cheese, blue cheese, brie cheese, cheddar cheese, cottage cheese, swiss cheese, lac vaccinum, goat milk, calcarea carbonica, lac defloratum, sepia, sulphur. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional

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.

Dairy Antigens 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.

  • WHEY 9 [hp_X]/mL
  • CALCIUM PHOSPHATE, UNSPECIFIED FORM 9 [hp_X]/mL
  • SODIUM CITRATE, UNSPECIFIED FORM 9 [hp_X]/mL
  • SODIUM CHLORIDE 9 [hp_X]/mL
  • SODIUM PHOSPHATE 9 [hp_X]/mL
  • SORBIC ACID 9 [hp_X]/mL
  • CITRIC ACID MONOHYDRATE 9 [hp_X]/mL
  • APOCAROTENAL 9 [hp_X]/mL
  • .BETA.-CAROTENE 9 [hp_X]/mL
  • CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED 9 [hp_X]/mL
  • CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED 9 [hp_X]/mL
  • CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED 9 [hp_X]/mL
  • CASEIN, LACTOCOCCUS LACTIS CULTURED 9 [hp_X]/mL
  • CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED 9 [hp_X]/mL
  • CASEIN, EMMENTAL CULTURED 9 [hp_X]/mL
  • COW MILK 9 [hp_X]/mL
  • GOAT MILK 9 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL
  • SKIM MILK 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 12 [hp_X]/mL
  • SULFUR 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.

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
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: 09-20-2013 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: 12-31-2019 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.

Dairy Antigens Product Label Images

Dairy Antigens 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 Cheese 9X, 12X, 15X, 30X, Blue Cheese 9X, 12X, 15X, 30X, Brie Cheese 9X, 12X, 15X, 30X, Cheddar Cheese 9X, 12X, 15X, 30X, Cottage Cheese 9X, 12X, 15X, 30X, Swiss Cheese 9X, 12X, 15X, 30X, Lac Vaccinum 9X, 12X, 15X, 30X, Goat Milk 9X, 12X, 15X, 30X, Calcarea Carbonica 12X, Lac Defloratum 12X, Sepia 12X, Sulphur 12X.

Indications:

For temporary relief of allergies due to milk products.

For temporary relief of allergies due to milk products.

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 a 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 NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935*For a complete list of Dairy Allersodes contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalDAIRY ANTIGENSHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.

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