NDC 53799-275 Ear Ringing Remedy

Allylthiourea, Arnica Montana Flower, Calcium Sulfide, Eriodictyon Californicum Leaf, Lachesis Muta Venom, Lycopodium Clavatum Spore, Quinine Sulfate, Silica Dimethyl Silylate

NDC Product Code 53799-275

NDC CODE: 53799-275

Proprietary Name: Ear Ringing Remedy 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: Allylthiourea, Arnica Montana Flower, Calcium Sulfide, Eriodictyon Californicum Leaf, Lachesis Muta Venom, Lycopodium Clavatum Spore, Quinine Sulfate, Silica Dimethyl Silylate 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

  • 53799 - Similasan Ag

NDC 53799-275-11

Package Description: 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ear Ringing Remedy with NDC 53799-275 is a a human over the counter drug product labeled by Similasan Ag. The generic name of Ear Ringing Remedy is allylthiourea, arnica montana flower, calcium sulfide, eriodictyon californicum leaf, lachesis muta venom, lycopodium clavatum spore, quinine sulfate, silica dimethyl silylate. The product's dosage form is solution and is administered via auricular (otic) form.

Labeler Name: Similasan Ag

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.

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.

Ear Ringing Remedy 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.

  • QUININE SULFATE 12 [hp_X]/10mL
  • CALCIUM SULFIDE 12 [hp_X]/10mL
  • LACHESIS MUTA VENOM 15 [hp_X]/10mL
  • ALLYLTHIOUREA 15 [hp_X]/10mL

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Auricular (otic) - Administration to or by way of the ear.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Similasan Ag
Labeler Code: 53799
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: 03-09-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ear Ringing Remedy 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

Arnica 15XChininum sulphuricum12XEriodictyon californicum 12XHepar 12XLachesis 15XLycopodium 12XSilica15XThiosinaminum 15X


Buzzingringing, hummingear discomfort, dizzinesspulsations/pounding, buzzingthrobbing, tinkling, roaring, cracking, buzzing, rolling, whizzing, resounding noise in earsringing, tinkling, buzzing, roaring, humming, whizzing in the earstinkling, clucking, roaring, singing, noises in earringing


According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with ear discomfort due to:• ringing
• buzzing
• roaring• humming
• pounding


  • Do not use in the eyes.According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If:

  • Symptoms persist for more than 48 hoursthere is discharge from the earthere is a fever of 102°F or greater

Ask A Doctor Before Use If You Have:

  • Ear drainage or dischargepain, irritation, or rash in the earhad ear surgerydizziness


  • 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.

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredient

Purified water, Vegetable glycerin


Reach our representatives at 1-800-240-9780 or [email protected] your protection do not use if tamper evident seal around neck of bottle is missing or broken.*Claims base on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

* Please review the disclaimer below.