NDC 44911-0414 Lyme HP

Baptisia Tinctoria, Echinacea (angustifolia), Hydrastis Canadensis, Borrelia Burgdorferi Nosode, Meningococcus Nosode, Encephalitis Nosode, Hepatitis B Nosode, Arsenicum Album, Bryonia (alba), Chelidonium Majus, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox

NDC Product Code 44911-0414

NDC Code: 44911-0414

Proprietary Name: Lyme HP 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: Baptisia Tinctoria, Echinacea (angustifolia), Hydrastis Canadensis, Borrelia Burgdorferi Nosode, Meningococcus Nosode, Encephalitis Nosode, Hepatitis B Nosode, Arsenicum Album, Bryonia (alba), Chelidonium Majus, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox 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

  • 44911 - Energique, Inc.
    • 44911-0414 - Lyme

NDC 44911-0414-1

Package Description: 120 mL in 1 BOTTLE, DROPPER

NDC Product Information

Lyme HP with NDC 44911-0414 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Lyme HP is baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, borrelia burgdorferi nosode, meningococcus nosode, encephalitis nosode, hepatitis b nosode, arsenicum album, bryonia (alba), chelidonium majus, colchicum autumnale, kalmia latifolia, ledum palustre, lycopodium clavatum, phosphorus, rhus tox. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, 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.

Lyme HP 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.

  • BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • GOLDENSEAL 6 [hp_X]/mL
  • BORRELIA BURGDORFERI 12 [hp_X]/mL
  • NEISSERIA MENINGITIDIS 15 [hp_X]/mL
  • JAPANESE ENCEPHALITIS VIRUS 18 [hp_X]/mL
  • HEPATITIS B VIRUS 30 [hp_X]/mL
  • ARSENIC TRIOXIDE 30 [hp_C]/mL
  • BRYONIA ALBA ROOT 30 [hp_C]/mL
  • CHELIDONIUM MAJUS 30 [hp_C]/mL
  • COLCHICUM AUTUMNALE BULB 30 [hp_C]/mL
  • KALMIA LATIFOLIA LEAF 30 [hp_C]/mL
  • LEDUM PALUSTRE TWIG 30 [hp_C]/mL
  • LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL
  • PHOSPHORUS 30 [hp_C]/mL
  • TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/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: Energique, Inc.
Labeler Code: 44911
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: 01-10-2017 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’.

* Please review the disclaimer below.

Lyme HP Product Label Images

Lyme HP 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:

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Hydrastis Canadensis 6X, Borrelia Burgdorferi Nosode 12X, 30X, 200X, Meningococcus Nosode 15X, 30X,200X, Encephalitis Nosode 18X, 30X, 200X, Hepatitis B Nosode 30X, 200X, Arsenicum Album 30C, Bryonia (Alba) 30C, Chelidonium Majus 30X, Colchicum Autumnale 30C, Kalmia Latifolia 30C, Ledum Palustre 30C, Lycopodium Clavatum 30C, Phosphorus 30C, Rhus Tox 30C.

Indications:

For temporary relief of aches and pains of joints and muscles as a consequence of Lyme Disease infection.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of aches and pains of joints and muscles as a consequence of Lyme Disease infection.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

If pregnant or breastfeeding, ask a health 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:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 20% Ethanol

Questions:

Dist. by Energique, Inc.201 Apple Blvd.Woodbine, IA 51579     800.868.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYLYME HP4 fl. oz. (120 ml)

* Please review the disclaimer below.

Previous Code
44911-0413
Next Code
44911-0415