FDA.reportPublic FDA data

Ear Ringing Remedy

Manufacturer
Similasan AG
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:21

Label at a glance#

ProductEar Ringing Remedy
Active ingredientARNICA MONTANA FLOWER, QUININE SULFATE, ERIODICTYON CALIFORNICUM LEAF, CALCIUM SULFIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SILICA DIMETHYL SILYLATE, ALLYLTHIOUREA
Label structure10 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with ear discomfort due to: • ringing       • buzzing       • roaring • humming       • pounding

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 more than 4...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica 15X
Chininum sulphuricum12X
Eriodictyon californicum 12X
Hepar 12X
Lachesis 15X
Lycopodium 12X
Silica15X
Thiosinaminum 15X

Purpose

OTC - PURPOSE SECTION

buzzing
ringing, humming
ear discomfort, dizziness
pulsations/pounding, buzzing
throbbing, tinkling, roaring, cracking, buzzing, rolling, whizzing, resounding noise in ears
ringing, tinkling, buzzing, roaring, humming, whizzing in the ears
tinkling, clucking, roaring, singing, noises in ear
ringing

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with ear discomfort due to:

• ringing       • buzzing       • roaring

• humming       • pounding

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, 

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 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

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

www.SimilasanUSA.com

For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

*Claims base on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Similasan
Ear Ringing Remedy
10 mL/ 0.33 fl oz

Similasan Ear Ringing Remedy 10 mL/ 0.33 fl ozSimilasan Ear Ringing Remedy 10 mL/ 0.33 fl oz

Similasan Ear Ringing Remedy 10 mL/ 0.33 fl ozSimilasan Ear Ringing Remedy 10 mL/ 0.33 fl oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-275-112025-01-30C16284748780-12cef2736-8e14-d83d-e063-dadaa90ab31fEar Ringing Remedy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-275-11Ear Ringing Remedy10 mL in 1 BOTTLE, DROPPERSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-275EAR RINGING REMEDY (ALLYLTHIOUREA, ARNICA MONTANA FLOWER, CALCIUM SULFIDE, ERIODICTYON CALIFORNICUM LEAF, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, QUININE SULFATE, SILICA DIMETHYL SILYLATE) SOLUTION [SIMILASAN AG]2Legacy NDC, 1 package rows20230106_f135892d-75e8-4cab-8938-2cbdaa3e7de1.zip

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
53799-27553799-275-11

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
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
QUININE SULFATEKF7Z0E0Q2BACTIB
ERIODICTYON CALIFORNICUM LEAF2Y7TIQ135HACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SILICA DIMETHYL SILYLATEEU2PSP0G0WACTIB
ALLYLTHIOUREA706IDJ14B7ACTIB
WATER059QF0KO0RIACT
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
ff025d2a-57e4-41b9-b720-80ccb5e9dfc1f135892d-75e8-4cab-8938-2cbdaa3e7de12021-03-11WarningsExact identifier
spl id: ff025d2a-57e4-41b9-b720-80ccb5e9dfc1
spl set id: f135892d-75e8-4cab-8938-2cbdaa3e7de1

Reported adverse events (FAERS/openFDA)#

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