FDA.reportPublic FDA data

Ear Wax Relief

Manufacturer
Similasan Corporation | Similasan AG
Effective date
2026-08-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-09-04 01:00:56

Label at a glance#

ProductEar Wax Relief
Active ingredientCAUSTICUM, GRAPHITE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE
Label structure15 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: clogged sensation when caused by ear wax ringing in the ear when caused by ear wax dry skin and itching of the ear canal

Dosage and administration

FOR USE IN THE EAR ONLY. For adults and children, over 12 years of age: Remove tamper evident seal from neck of bottle. Twist cap off bottle. Tilt head sideways, squeeze plastic applicator to release 2-3 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 twice daily...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Causticum 12X

Purpose

OTC - PURPOSE SECTION

itching, wax build-up

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Graphites 15X

Purpose

OTC - PURPOSE SECTION

dryness, wax build-up

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lachesis 12X

Purpose

OTC - PURPOSE SECTION

dryness, wax build-up

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lycopodium 12X

Purpose

OTC - PURPOSE SECTION

wax build-up

Uses:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

  • clogged sensation when caused by ear wax
  • ringing in the ear when caused by ear wax
  • dry skin and itching of the ear canal

Warnings:

WARNINGS SECTION

  • According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
  • Avoid contact with eyes.

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.

Do not use:

OTC - DO NOT USE SECTION

  • if you have ear drainage, discharge, ear pain, irritation, a rash in the ear, or are dizzy; consult a doctor
  • if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
  • for more than 48 hours; if excessive ear wax remains after the use of this product, consult a doctor
  • with ear tubes

Directions:

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY.

For adults and children, over 12 years of age:

  • Remove tamper evident seal from neck of bottle.
  • Twist cap off bottle.
  • Tilt head sideways, squeeze plastic applicator to release 2-3 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 twice daily for up to 2 days if needed, or as directed by a doctor.
  • Any wax remaining after treatment may be removed by with warm water, using a soft, rubber bulb ear syringe.
  • 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

Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 59262-272-11
Similasan
Ear Wax Relief
EAR DROPS
10 ml / 0.33 fl oz

Principle Display Panel NDC 59262-272-11 Similasan Ear Wax Relief EAR DROPS 10 ml / 0.33 fl ozPrinciple Display Panel NDC 59262-272-11 Similasan Ear Wax Relief EAR DROPS 10 ml / 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-272-112025-04-09C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112025-04-09C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112025-01-30C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112025-01-30C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112020-04-15C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112020-04-15C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112020-01-31C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief
59262-272-112020-01-31C16284748780-19d75b9cf-d6d3-f424-e053-dadaa90a57ceEar Wax Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-272-11ML - Milliliter59262-2727086031b-2444-4d90-9d55-551265819e2f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU9
GRAPHITEACTIVE INGREDIENT4QQN74LH4O9
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I9
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4799
CAUSTICUMACTIVE MOIETYDD5FO1WKFU9
GRAPHITEACTIVE MOIETY4QQN74LH4O9
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I9
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4799
GLYCERININACTIVE INGREDIENTPDC6A3C0OX9

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
59262-27259262-272-11

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
CAUSTICUMDD5FO1WKFUACTIB
GRAPHITE4QQN74LH4OACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-04-10full-release2026-06-01 02:33:11

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Ear Wax ReliefCAUSTICUM, GRAPHITE, LACHESIS MUTA VENOM AND LYCOPODIUM CLAVATUM SPORESimilasan Corporation1b548338-f9f0-4a63-b553-df4fcd18d5942026-08-05WarningsExact identifier
ndc (package): 59262-272-11
ndc (product): 59262-272
ndc11 (package): 59262027211
spl id: 5851ed73-15f2-1925-e063-6294a90a96a8
spl set id: 1b548338-f9f0-4a63-b553-df4fcd18d594

Reported adverse events (FAERS/openFDA)#

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