NDC 54973-3392 4 Kids Earache Relief

Atropa Belladonna,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore,anemone Pulsatilla,sulfur And Matricaria Chamomilla

NDC Product Code 54973-3392

NDC Code: 54973-3392

Proprietary Name: 4 Kids Earache Relief 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: Atropa Belladonna,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore,anemone Pulsatilla,sulfur And Matricaria Chamomilla 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

  • 54973 - Hyland�s
    • 54973-3392 - 4 Kids Earache Relief

NDC 54973-3392-1

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

NDC Product Information

4 Kids Earache Relief with NDC 54973-3392 is a a human over the counter drug product labeled by Hyland�s. The generic name of 4 Kids Earache Relief is atropa belladonna,oyster shell calcium carbonate, crude,lycopodium clavatum spore,anemone pulsatilla,sulfur and matricaria chamomilla. 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.

4 Kids Earache Relief 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.

  • 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.

  • 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: 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: 03-01-2019 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: 12-31-2020 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.

4 Kids Earache Relief Product Label Images

4 Kids Earache Relief 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

Belladonna 30C HPUS (less than 0.000000000001% Alkaloids,calculated)Calcarea Carbonica 30C HPUSChamomilla 30C HPUSLycopodium 30C HPUSPulsatilla 30C HPUSSulphur 30C HPUS“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.


Belladonna 30C HPUS..............minor feverCalcarea Carbonica 30C HPUS...throbbing ear painChamomilla 30C HPUS .............occasional sleeplessness and irritabilityLycopodium 30C HPUS ................ ear painPulsatilla 30C HPUS................. ear itching, pain worse at nightSulphur 30C HPUS... ear pain with burning


  • Temporarily relieves the symptoms of:minor feverear pain or throbbingirritability or occasional sleeplessness associated with earaches after diagnosis by a physiciancommon pain or itching of “swimmer’s ear”

Keep Away From Eyes. Do Not Take By Mouth.

Earache drops are only to be used in 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 - Do Not Use

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

Consult A Physician If

  • Symptoms persist for more than 48 hours or worsen.discharge from ear is present.symptoms are accompanied by a high fever (over 101ºF).

Keep This And All Medications Out Of The Reach Of Children.

If swallowed, 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.


Children ages 2 years and
over: Tilt head sideways and apply 3–4 drops into involved ear 4 times daily until relieved.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.



* Please review the disclaimer below.

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