FDA.reportPublic FDA data

EarStill

Manufacturer
Silver Star Brands | OHM Pharma
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:29:57

Label at a glance#

ProductEarStill
Active ingredientSALICYLIC ACID, CARBON DISULFIDE, QUININE SULFATE, MANGANESE, CALCIUM FLUORIDE
Label structure10 sections

Indications and uses

Uses*: Homeopathic remedy to relieve occasional ringing and buzzing in the ears. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Directions: Mix in 1/4 cup water and sip slowly. Alternatively, drops may be taken directly into the mouth. Adults & children 12+: Take 0.50 mL every hour for 6 doses. Thereafter, use as needed until symptoms improve.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Equal volumnes of each ingredient: Calc fluor 30C, Carboneum sulph 6C, Chininum sulph 6C, Mang met 6C, Salicylicum ac 6C.

Uses*:

INDICATIONS & USAGE SECTION

Uses*: Homeopathic remedy to relieve occasional ringing and buzzing in the ears.

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

Warnings

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Mix in 1/4 cup water and sip slowly. Alternatively, drops may be taken directly into the mouth. Adults & children 12+: Take 0.50 mL every hour for 6 doses. Thereafter, use as needed until symptoms improve.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if safety seals is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Grain alcohol (20% by volume), USP Purified water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - PURPOSE SECTION

Relieves occasional ringin, roaring, & buzzing sounds*

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EarStillEarStill

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
68703-322-022023-03-06C16284748780-1ba0f9c33-2f07-a910-e053-dadaa90a0b85NativeRemedies® EarStill™
68703-322-022021-01-29C16284748780-1ba0f9c33-2f07-a910-e053-dadaa90a0b85NativeRemedies® EarStill™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-322-02EarStill59 mL in 1 BOTTLE, GLASSLIQUID595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-322EARSTILL (CALC FLUOR, CARBONEUM SULPH, CHININUM SULPH, MANG MET, SALICYLICUM AC) LIQUID [SILVER STAR BRANDS]5Current NDC, Legacy NDC, 1 package rows20250103_8258987a-d9ea-fc24-e053-2991aa0a7e24.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-32268703-322-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
CARBON DISULFIDES54S8B99E8ACTIB
QUININE SULFATEKF7Z0E0Q2BACTIB
MANGANESE42Z2K6ZL8PACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
EarStillCALC FLUOR, CARBONEUM SULPH, CHININUM SULPH, MANG MET, SALICYLICUM ACSilver Star Brands8258987a-d9ea-fc24-e053-2991aa0a7e242025-01-01WarningsExact identifier
ndc (package): 68703-322-02
ndc (product): 68703-322
ndc11 (package): 68703032202
spl id: 2ab0f66a-fdaf-1f10-e063-6294a90af7bc
spl set id: 8258987a-d9ea-fc24-e053-2991aa0a7e24

Reported adverse events (FAERS/openFDA)#

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