FDA.reportPublic FDA data

Kids Earache Relief

Manufacturer
Similasan Corporation
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:19:18

Label at a glance#

ProductKids Earache Relief
Active ingredientMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, PULSATILLA PATENS WHOLE, 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. For children ages 2 and over: • Remove tamper-evident seal from neck of bottle. • Twist cap off bottle. • Tilt child’s head sideways. • DON'T squeeze bottle, squeeze plastic tip to release 4-5 drops into ear (tip of applicator should not enter ear canal). • Keep drops in ear for 3-5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear. ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts – Kids Earache Relief

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 10X

Mercurius solubilis 15X

Pulsatilla 12X

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

sensitivity to drafts, soothing

fullness, sensitivity to cold

night time calmative

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.

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 the child has:

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.

For children ages 2 and over:

• Remove tamper-evident seal from neck of bottle.

• Twist cap off bottle.

• Tilt child’s head sideways.

• DON'T squeeze bottle, squeeze plastic tip to release 4-5 drops into ear (tip of applicator should not enter ear canal).

• Keep drops in ear for 3-5 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.

Other information

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-276-11
Similasan
Kids 
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz

Text, calendar Description automatically generatedText, calendar Description automatically generated

Diagram Description automatically generatedDiagram Description automatically generated

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-276-112025-01-30C16284748780-1ba0f9c33-37d7-a910-e053-dadaa90a0b85Kids Earache Relief
59262-276-112021-04-21C16284748780-1ba0f9c33-37d7-a910-e053-dadaa90a0b85Kids Earache Relief
59262-276-112021-01-29C16284748780-1ba0f9c33-37d7-a910-e053-dadaa90a0b85Kids Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-276-11Kids Earache Relief1 in 1 BOXSOLUTION14
59262-276-11Kids Earache Relief10 mL in 1 BOTTLE, DROPPERSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-276KIDS EARACHE RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]4Legacy NDC, 2 package rows20230106_a3faf900-0d32-4566-8af2-b06da7512792.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
59262-27659262-276-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PULSATILLA PATENS WHOLE4M1169RWJDACTIB
SULFUR70FD1KFU70ACTIB
GLYCERINPDC6A3C0OXIACT

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
9055bf93-f2ed-42ae-8415-637b0f93cdf1a3faf900-0d32-4566-8af2-b06da75127922021-10-07WarningsExact identifier
spl id: 9055bf93-f2ed-42ae-8415-637b0f93cdf1
spl set id: a3faf900-0d32-4566-8af2-b06da7512792

Reported adverse events (FAERS/openFDA)#

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