Earache Relief Solution
NDC 53799-277

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 53799-277?
  4. Earache Relief Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Earache Relief (chamomilla and mercurius solubilis and sulphur) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Similasan Ag. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a solution for auricular (otic) administration. This product entry covers the primary NDC 53799-277 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53799-277
Proprietary Name:
Earache Relief
Non-Proprietary Name: [1]
Chamomilla And Mercurius Solubilis And Sulphur
Substance Name: [2]
Chamomile; Mercurius Solubilis; Sulfur
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
Auricular (otic) - Administration to or by way of the ear.

Labeler & Regulatory Data

Labeler Name: [5]
Similasan Ag
Labeler Code:
53799
Product Label ID:
b9749db9-a2e4-4460-8769-6150285a7413
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
07-02-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 53799-277?

The NDC code 53799-277 is assigned by the FDA to the product Earache Relief. It is commonly known by its generic name, chamomilla and mercurius solubilis and sulphur. This pharmaceutical product is labeled by Similasan Ag and is currently categorized as listed product. The medication is a solution administered via auricular (otic) route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 53799-277-11. 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?

FOR USE IN THE EAR ONLY.• Remove tamper-evident seal from neck of bottle.• Twist cap off bottle.• Tilt head sideways.• DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.• Children under 12 years of age consult a doctor.

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.
  • CHAMOMILE 10 [hp_X]/10mL - Common name for several daisy-like plants (MATRICARIA; TRIPLEUROSPERMUM; ANTHEMIS; CHAMAEMELUM) native to Europe and Western Asia, now naturalized in the United States and Australia.
  • MERCURIUS SOLUBILIS 15 [hp_X]/10mL
  • SULFUR 12 [hp_X]/10mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.

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:

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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".