WALGREENS EARACHE DROPS

Manufacturer
Walgreen Company
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:56

Label at a glance#

ProductWALGREENS EARACHE DROPS
Active ingredientBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS WHOLE, SULFUR
Label structure10 sections

Indications and uses

Uses* • For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmer’s ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage and administration

Directions Suitable for adults and children overtheageof2.•Forusein the ears only. • Remove any hearing aids before using this product. • Use 3 to 5 drops four times per day or as needed. • Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 1 – 2 m...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose

Belladonna 30C HPUS

Fever
Calcarea Carbonica 30C HPUSThrobbing ear pain
Chamomilla 30C HPUSSleeplessness and irritability
Lycopodium 30C HPUSEar pain
Pulsatilla 30C HPUSEar itching, pain worse at night
Sulphur 30C HPUSEar pain with burning



"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

OTC - PURPOSE SECTION

Belladonna - Fever
Calcarea carbonica - Throbbing ear pain
Chamomilla - Sleeplessness and irritability
Lycopodium - Ear pain Pulsatilla - Ear itching, pain worse at night
Sulphur - Ear pain with burning

Uses

INDICATIONS & USAGE SECTION

Uses*

• For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmer’s ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

WARNINGS SECTION

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. • Keep away from eyes. • Do not take by mouth. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur. • A Physician should always be consulted to rule out serious causes.

• If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not use: • If you have ear drainage, irritation, discharge or rash in the ear, consult a physician • With ear tubes, damaged ear drums or after surgery. • If drops become cloudy.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

• Symptoms worsen or continue for more than 48 hours. • There is discharge from the ear. • A fever greater than 102o F is present.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Suitable for adults and children overtheageof2.•Forusein the ears only. • Remove any hearing aids before using this product. • Use 3 to 5 drops four times per day or as needed.

• Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 1 – 2 minutes or gently place cotton in the ear to keep drops in.

Other information

SPL UNCLASSIFIED SECTION

Active ingredients are micro diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects. • Store at 15 o C - 30 o C (59 o F-86 o F ). • Protect from light and excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium chloride, Citric acid, Glycerin, Purified water.

Questions or comments?

OTC - QUESTIONS SECTION

• 1-800-925-4733 • 9am– 5pm EST Monday - Friday

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917217123GTIN-13: 0311917217123
EAN-13: 0311917217123
GTIN-12: 311917217123
UPC-A: 311917217123
GTIN storage (14 digits): 00311917217123
WAG_EE_201994_EarAcheDrops_BOX.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3233-152025-12-15C16284748780-12cef2736-9395-d83d-e063-dadaa90ab31fWalgreens Earache Drops
0363-3233-152025-01-30C16284748780-12cef2736-9395-d83d-e063-dadaa90ab31fWalgreens Earache Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3233-15WALGREENS EARACHE DROPS10 mL in 1 BOTTLE, DROPPERLIQUID103
0363-3233-15WALGREENS EARACHE DROPS1 in 1 CARTONLIQUID13

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-32330363-3233-15

Ingredients#

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

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

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
WALGREENS EARACHE DROPSBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFURWalgreen Companyc573dc3c-992e-604d-e053-2995a90a0ff42025-11-19WarningsExact identifier
ndc (package): 0363-3233-15
ndc (product): 0363-3233
ndc11 (package): 00363323315
spl id: 43f4e055-220f-beba-e063-6394a90a1085
spl set id: c573dc3c-992e-604d-e053-2995a90a0ff4

Reported adverse events (FAERS/openFDA)#

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