NDC 54973-3172 Earache Drops

Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Anemone Patens, And Sulfur

NDC Product Code 54973-3172

NDC CODE: 54973-3172

Proprietary Name: Earache Drops 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: Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Anemone Patens, And Sulfur 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

NDC 54973-3172-1

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC 54973-3172-2

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 12 mL in 1 BOTTLE, DROPPER

NDC Product Information

Earache Drops with NDC 54973-3172 is a a human over the counter drug product labeled by Hyland's. The generic name of Earache Drops is belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Hyland's

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.

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.

  • BELLADONNA LEAF 30 [hp_C]/mL
  • CALCIUM CARBONATE 30 [hp_C]/mL
  • CHAMOMILE 30 [hp_C]/mL
  • LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL
  • ANEMONE PATENS WHOLE 30 [hp_C]/mL
  • SULFUR 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Hyland's
Labeler Code: 54973
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: 06-17-2004 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: 12-31-2021 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.

Earache Drops Product Label Images

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

Other

Drug Facts

Otc - Active Ingredient

Active ingredientsPurposeBelladonna 30C HPUS
(0.000000000001% Alkaloids, Calculated
feverCalcarea Carbonica 30C HPUSthrobbing ear painChamomilla 30C HPUSoccasional sleeplessness and irritabilityLycopodium 30C HPUSear painPulsatilla 30C HPUSear itching, pain worse at nightSulphur 30C HPUSear pain with burning"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of fever, pain, throbbing, irritability and occasional sleeplessness associated with earaches after diagnosis by a physician. Relieves common pain and itching of "swimmer's" ear.

Warnings

Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal.

Otc - Pregnancy Or Breast Feeding

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Otc - Ask Doctor

  • Consult a physician if:Symptoms persist for more than 48 hoursDischarge from the ear is present

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.

Otc - Do Not Use

Do not use if imprinted tamper band is broken or missing.

Otc - Ask Doctor/Pharmacist

In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

Adults and children 2 years and up: Tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in.

Inactive Ingredients

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Otc - Purpose

Temporarily relieves the symptoms of fever, pain, throbbing, irritability and occasional sleeplessness associated with earaches after diagnosis by a physician. Relieves common pain and itching of "swimmer's" ear.

* Please review the disclaimer below.