Ear Care Liquid
NDC 55714-4846

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 55714-4846?
  4. Ear Care Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Ear Care (influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, causticum, cinchona, conium, dulcamara, ferrum phosphoricum, hepar sulph. calc.,kali sulph., lycopodium, merc. viv., mezereum, phosphorus, plantago, pulsatilla, silicea, verbascum, echinacea, hydrastis) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Newton Laboratories, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 55714-4846 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
55714-4846
Proprietary Name:
Ear Care
Non-Proprietary Name: [1]
Influenzinum, Tellurium Metallicum, Apis Mel., Arsenicum Alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum Phosphoricum, Hepar Sulph. Calc., Kali Sulph., Lycopodium, Merc. Viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis
Substance Name: [2]
Anemone Pulsatilla; Apis Mellifera; Arsenic Trioxide; Atropa Belladonna; Bryonia Alba Root; Calcium Sulfide; Capsicum; Causticum; Cinchona Officinalis Bark; Conium Maculatum Flowering Top; Daphne Mezereum Bark; Echinacea, Unspecified; Ferrosoferric Phosphate; Goldenseal; Influenza A Virus; Influenza B Virus; Lycopodium Clavatum Spore; Mercury; Phosphorus; Plantago Major; Potassium Sulfate; Silicon Dioxide; Solanum Dulcamara Top; Tellurium; Verbascum Thapsus
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Newton Laboratories, Inc.
Labeler Code:
55714
Product Label ID:
da821d05-b2f0-3582-e053-2a95a90afe59
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
03-07-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 55714-4846?

The NDC code 55714-4846 is assigned by the FDA to the product Ear Care. It is commonly known by its generic name, influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, causticum, cinchona, conium, dulcamara, ferrum phosphoricum, hepar sulph. calc., kali sulph., lycopodium, merc. viv., mezereum, phosphorus, plantago, pulsatilla, silicea, verbascum, echinacea, hydrastis. This pharmaceutical product is labeled by Newton Laboratories, Inc. and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 55714-4846-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ANEMONE PULSATILLA 15 [hp_X]/mL
  • APIS MELLIFERA 15 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL - An inorganic compound with the chemical formula As2O3 that is used for the treatment of ACUTE PROMYELOCYTIC LEUKEMIA in patients who have relapsed from, or are resistant to, conventional drug therapy.
  • ATROPA BELLADONNA 15 [hp_X]/mL - A plant species of the genus ATROPA, family SOLANACEAE that contains ATROPINE; SCOPOLAMINE; BELLADONNA ALKALOIDS and other SOLANACEOUS ALKALOIDS. Some species in this genus are called deadly nightshade which is also a common name for SOLANUM.
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • CALCIUM SULFIDE 15 [hp_X]/mL - RN given refers to parent cpd; see also record for lime sulfur (calcium polysulfide)
  • CAPSICUM 15 [hp_X]/mL - A plant genus of the family SOLANACEAE. The hot peppers yield CAPSAICIN, which activates VANILLOID RECEPTORS. Several varieties have sweet or pungent edible fruits that are used as vegetables when fresh and spices when the pods are dried.
  • CAUSTICUM 15 [hp_X]/mL - contains calcium hydroxide & potassium bisulfite; Homeopathic drug
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/mL
  • CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/mL
  • DAPHNE MEZEREUM BARK 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 6 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 15 [hp_X]/mL
  • GOLDENSEAL 6 [hp_X]/mL
  • INFLUENZA A VIRUS 30 [hp_X]/mL - The type species of the genus ALPHAINFLUENZAVIRUS that causes influenza and other diseases in humans and animals. Antigenic variation occurs frequently between strains, allowing classification into subtypes and variants. Transmission is usually by aerosol (human and most non-aquatic hosts) or waterborne (ducks). Infected birds shed the virus in their saliva, nasal secretions, and feces.
  • INFLUENZA B VIRUS 30 [hp_X]/mL - Species of the genus BETAINFLUENZAVIRUS that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
  • MERCURY 15 [hp_X]/mL - A silver metallic element that exists as a liquid at room temperature. It has the atomic symbol Hg (from hydrargyrum, liquid silver), atomic number 80, and atomic weight 200.59. Mercury is used in many industrial applications and its salts have been employed therapeutically as purgatives, antisyphilitics, disinfectants, and astringents. It can be absorbed through the skin and mucous membranes which leads to MERCURY POISONING. Because of its toxicity, the clinical use of mercury and mercurials is diminishing.
  • PHOSPHORUS 15 [hp_X]/mL - A non-metal element that has the atomic symbol P, atomic number 15, and atomic weight 31. It is an essential element that takes part in a broad variety of biochemical reactions.
  • PLANTAGO MAJOR 15 [hp_X]/mL
  • POTASSIUM SULFATE 15 [hp_X]/mL - RN given refers to cpd with MF of K2-H2SO4
  • SILICON DIOXIDE 15 [hp_X]/mL - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.
  • SOLANUM DULCAMARA TOP 15 [hp_X]/mL
  • TELLURIUM 16 [hp_X]/mL - An element that is a member of the chalcogen family. It has the atomic symbol Te, atomic number 52, and atomic weight 127.60. It has been used as a coloring agent and in the manufacture of electrical equipment. Exposure may cause nausea, vomiting, and CNS depression.
  • VERBASCUM THAPSUS 15 [hp_X]/mL - A plant genus of the family Scrophulariaceae.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".