NDC 53799-405 Earache Drops

Chamomilla, Mercurius Solubilis And Sulphur

NDC Product Code 53799-405

NDC 53799-405-11

Package Description: 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Earache Drops with NDC 53799-405 is a a human over the counter drug product labeled by Similasan Ag. The generic name of Earache Drops is chamomilla, mercurius solubilis and sulphur. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Earache Drops 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.

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: 09-08-2021 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.

Earache Drops 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 -

Chamomilla 10XMercurius solubilis 15XSulphur 12X


Sensitivity to drafts, soothingfullness, sensitivity to colditchiness, sensitivity to water


According to homeopathic principles, the active ingredients in this product temporarily relieve earache symptoms such as:• sensation of fullness of the ear• sensitivity to cold, drafts, and water• the annoyance of water-clogged ears by helping clear water trapped in the ear


• 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. 1-800-222-1222

Stop Use And Ask A Doctor If:

• symptoms persist for more than 48 hours• there is discharge from the ear• there is a fever of 102°F or greater

Ask A Doctor Before Use If You Have:

• ear drainage or discharge• pain, irritation, or rash in the ear• had ear surgery• dizziness


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



* Please review the disclaimer below.