Earache Drops

Manufacturer
Similasan AG | Walgreen Company
Effective date
2021-09-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:13

Label at a glance#

ProductEarache Drops
Active ingredientCHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Label structure10 sections

Indications and uses

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

Dosage and administration

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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients -

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

sensitivity to drafts, soothing

fullness, sensitivity to cold

itchiness, sensitivity to water

Uses*

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• 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:

OTC - ASK DOCTOR SECTION

• ear drainage or discharge

• pain, irritation, or rash in the ear

• had ear surgery

• dizziness

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Purified water, Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

1-800-250-9780

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Earache
Drops

0.33 FL OZ (10 mL)

Earache Drops 0.33 FL OZ (10 mL)Earache Drops 0.33 FL OZ (10 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-405-112025-01-30C16284748780-12cef2736-a3da-d83d-e063-dadaa90ab31fWalgreens Earache Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-405-11Earache Drops10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-405EARACHE DROPS (CHAMOMILLA, MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION/ DROPS [SIMILASAN AG]2Legacy NDC, 1 package rows20230106_4dd41edd-84a5-4e13-b6a9-7d6000ad787f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-40553799-405-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
89edf769-8377-4ab3-bd37-5f12a07ac7ee4dd41edd-84a5-4e13-b6a9-7d6000ad787f2021-09-10WarningsExact identifier
spl id: 89edf769-8377-4ab3-bd37-5f12a07ac7ee
spl set id: 4dd41edd-84a5-4e13-b6a9-7d6000ad787f

Reported adverse events (FAERS/openFDA)#

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