FDA.reportPublic FDA data

Walgreens Earache Drops

Manufacturer
Walgreens Co | Sheffield Pharmaceuticals LLC
Effective date
2019-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:53

Label at a glance#

ProductWalgreens Earache Drops
Active ingredientATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, SULFUR
Label structure12 sections

Indications and uses

For use I ear only, according to homeopathic indications these ingredients temporaily relieve the symptoms of  fever, pain, throbbing and sleeplessness, with ear aches after diagnosis by a physician. Relieves common pain and itching due ot cold and flu "swimmers ear "& allergies.

Dosage and administration

Adults and children over the age of 2 years :   For use in the ear only  Remove any hearing aids before using this product Use 3 to 5 drops twice per day or as needed  Warm the content to body temperature by holding in your hands Tilt head sideways and let solution drip into ear. Tip of applicator should not enter ear canal.  Keep drops in ear for 1 to 2 minutes by keeping head tilted or placing cotton in the ear. 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna 30C HPUS, Calcarea Carbonica 30C HPUS, Chamomilla 30C HPUS, Lycopodium Clavatum 30C HPUS, Pulsatilla 30C HPUS, Sulphur 30C HPUS

Purpose

OTC - PURPOSE SECTION

Fever, Throbbing ear pain, Sleeplessness and irritability, Ear pain, Ear itching pain worse at night , Ear pain with burning 

Uses

INDICATIONS & USAGE SECTION

For use I ear only, according to homeopathic indications these ingredients temporaily relieve the symptoms of  fever, pain, throbbing and sleeplessness, with ear aches after diagnosis by a physician. Relieves common pain and itching due ot cold and flu "swimmers ear "& allergies.

Warnings

WARNINGS SECTION

Use only after diagonsis by a physcian and under the supervisor or a physcian

Keep away from eyes

  • this product is intended or compliment , not replace standard medical treatment 
  • initial worsening of symptoms may occur
  • A Physician should always be consulted to rule out serious causes 

If pregnant or breast feeding, ask a health care professional before use.

Stop Use and ask a Doctor if

OTC - DO NOT USE SECTION

  • Symptoms worsenor continue for more than 48 hours 
  • There is dischare for the ear
  • A fever greater than 102°F is present

Do not use 

  • If if you have irritation, discharge or rash in the ear, consult a physician 
  • with ear tube, damaged ear drums or after surgery 
  • If product becomes cloudy 

When using this product 

OTC - WHEN USING SECTION

  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions FOR USE IN THE EAR ONLY

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over the age of 2 years :  
  • For use in the ear only 
  • Remove any hearing aids before using this product
  • Use 3 to 5 drops twice per day or as needed 
  • Warm the content to body temperature by holding in your hands
  • Tilt head sideways and let solution drip into ear.
  • Tip of applicator should not enter ear canal. 
  • Keep drops in ear for 1 to 2 minutes by keeping head tilted or placing cotton in the ear. 

Other information

OTHER SAFETY INFORMATION

  • Protect from light and excessive moisture 
  • Active ingredient are micro dilutions in accordance with the Homeopathic Pharmacopeia of the United States and are therefore non toxic with no known side effects 

Inactive ingredients

INACTIVE INGREDIENT SECTION

 Benzalkonium Chloride, Citric Acid, Glycerin, Water

Principal Display Panel -Bottle Label 0.34 FLOZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreen NDC 0363-2120-42

Earache Drops

Homoepathic

  • Releives Pain
  • Calms Irritability

0.34 FLOZ (10ml)

Principal Display Panel -Bottle Label 0.34 FLOZPrincipal Display Panel -Bottle Label 0.34 FLOZ

Principal Display Panel Box label 0.34 FLOZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens NDC 0363-2120-42

Eareache Drops 

Homoepathic

  • Relieves Pain
  • Calms Irritability 

0.34 FLOZ (10ml)

Principal Display Panel Box label 0.34 FLOZPrincipal Display Panel Box label 0.34 FLOZ

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-2120-422021-01-29C16284748780-1ba0f9c33-545c-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2120-42Walgreens Earache Drops1 in 1 CARTONSOLUTION/ DROPS11
0363-2120-42Walgreens Earache Drops10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2120WALGREENS EARACHE DROPS (HPUS EARACHE DROPS) SOLUTION/ DROPS [WALGREENS CO]1Legacy NDC, 2 package rows20191224_43b91ab6-3588-480d-a180-0239043da2e9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-21200363-2120-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SULFUR70FD1KFU70ACTIB
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d12b6f0b-75e8-480c-bf58-c1a9cc403e5d43b91ab6-3588-480d-a180-0239043da2e92019-12-13WarningsExact identifier
spl id: d12b6f0b-75e8-480c-bf58-c1a9cc403e5d
spl set id: 43b91ab6-3588-480d-a180-0239043da2e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.