NDC 55714-2329 Edema - Fluid Retention

Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.

NDC Product Code 55714-2329

NDC Code: 55714-2329

Proprietary Name: Edema - Fluid Retention 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: Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur. 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-2329 - Edema - Fluid Retention

NDC 55714-2329-0

Package Description: 7.08 g in 1 BOTTLE, GLASS

NDC 55714-2329-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-2329-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Edema - Fluid Retention with NDC 55714-2329 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Edema - Fluid Retention is elaps corallinus, apis mel., arsenicum alb., cantharis, cinchona, colchicum, convallaria, crotalus horridus, digitalis, juniperus com., lachesis, merc. viv., naja, nat. carb., nat.sulphuricum, rhus toxicodendron, sambucus nig., strophanthus hispidus, thuja occ., vipera berus, echinacea, lappa, solidago, taraxacum, urtica ur.. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Edema - Fluid Retention 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.

  • MICRURUS CORALLINUS VENOM 30 [hp_X]/g
  • APIS MELLIFERA 10 [hp_X]/g
  • ARSENIC TRIOXIDE 10 [hp_X]/g
  • LYTTA VESICATORIA 10 [hp_X]/g
  • CINCHONA OFFICINALIS BARK 10 [hp_X]/g
  • COLCHICUM AUTUMNALE BULB 10 [hp_X]/g
  • CONVALLARIA MAJALIS 10 [hp_X]/g
  • CROTALUS HORRIDUS HORRIDUS VENOM 10 [hp_X]/g
  • DIGITALIS 10 [hp_X]/g
  • JUNIPERUS COMMUNIS FRUIT 10 [hp_X]/g
  • LACHESIS MUTA VENOM 10 [hp_X]/g
  • MERCURY 10 [hp_X]/g
  • NAJA NAJA VENOM 10 [hp_X]/g
  • SODIUM CARBONATE 10 [hp_X]/g
  • SODIUM SULFATE 10 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/g
  • SAMBUCUS NIGRA FLOWERING TOP 10 [hp_X]/g
  • STROPHANTHUS HISPIDUS SEED 10 [hp_X]/g
  • THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]/g
  • VIPERA BERUS VENOM 10 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/g
  • ARCTIUM LAPPA ROOT 3 [hp_X]/g
  • SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]/g
  • TARAXACUM OFFICINALE 3 [hp_X]/g
  • URTICA URENS 3 [hp_X]/g

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.

  • SUCROSE (UNII: C151H8M554)

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: Newton Laboratories, Inc.
Labeler Code: 55714
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: 03-01-2011 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.

Edema - Fluid Retention Product Label Images

Edema - Fluid Retention 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

Indications & Usage Section

Edema - Fluid Retention  Formulated for associated symptoms such as skin discoloration, discomfort and swelling due to fluid retention.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc - Active Ingredient Section

Elaps corallinus 30x, Apis mel. 10x, Arsenicum alb. 10x, Cantharis 10x, Cinchona 10x, Colchicum 10x, Convallaria 10x, Crotalus horridus 10x, Digitalis 10x, Juniperus com.10x, Lachesis 10x, Merc. viv. 10x, Naja 10x, Nat. carb. 10x, Nat.sulphuricum 10x, Rhus toxicodendron 10x, Sambucus nig. 10x, Strophanthus hispidus 10x, Thuja occ. 10x, Vipera berus 10x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.

Otc - Purpose Section

Formulated for associated symptoms such as skin discoloration, discomfort and swelling due to fluid retention.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Questions Section

Www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

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