NDC 43857-0435 Systemic Detox

Systemic Detox with NDC 43857-0435 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Systemic Detox is berberis vulgaris, boldo, chelidonium majus, lappa major, taraxacum officinale, trifolium pratense, hydrastis canadensis, condurango, ginkgo biloba, tabebuia impetiginosa, conium maculatum, hepar sulphuris calcareum, lycopodium clavatum, sarsaparilla (smilax regelii), aloe, echinacea (angustifolia), natrum sulphuricum, nux vomica, thuja occidentalis. 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.

Systemic Detox 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.

• BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
• PEUMUS BOLDUS LEAF 3 [hp_X]/mL
• CHELIDONIUM MAJUS 3 [hp_X]/mL
• ARCTIUM LAPPA ROOT 3 [hp_X]/mL
• TARAXACUM OFFICINALE 3 [hp_X]/mL
• TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
• GOLDENSEAL 5 [hp_X]/mL
• MARSDENIA CONDURANGO BARK 6 [hp_X]/mL
• GINKGO 6 [hp_X]/mL
• TABEBUIA IMPETIGINOSA BARK 6 [hp_X]/mL
• CONIUM MACULATUM FLOWERING TOP 12 [hp_X]/mL
• CALCIUM SULFIDE 12 [hp_X]/mL
• LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
• SMILAX REGELII ROOT 12 [hp_X]/mL
• ALOE 30 [hp_X]/mL
• ECHINACEA ANGUSTIFOLIA 30 [hp_X]/mL
• SODIUM SULFATE 30 [hp_X]/mL
• STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/mL
• THUJA OCCIDENTALIS LEAFY TWIG 30 [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, 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: 03-01-2017 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’.

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