FDA.reportPublic FDA data

DoloEar

Manufacturer
Pharmadel LLC
Effective date
2023-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:23:01

Label at a glance#

ProductDoloEar
Active ingredientATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, LACHESIS MUTA VENOM, THUJA OCCIDENTALIS LEAFY TWIG, MATRICARIA CHAMOMILLA
Label structure9 sections

Indications and uses

Temporarily relieves earache symptoms associated with common pain and itching of swimmer's ear clogged ears ear pain or itching from other earaches after diagnosis by a doctor

Dosage and administration

shake before use adults and children ages 6 and older: tilt head sideways and apply 2-3 drops into the ear (tip of dropper should not enter the ear canal) keep head tilted and allow drops to remain in the ear for 2 minutes or gently place cotton in ear to keep drops in repeat as needed, up to 4 times a day

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients** (HPUS)Purposes*
Apis melifica 6C .......................

Ear pain, inflammation

Aristolochia clematitis 6C.........Earache inflammation
Belladonna 6C..........................Throbbing pain
Chamomilla vulgaris 6C ..........

Ear pain irritability

Lachesis mutus 6C ..................Ear inflammation
Thuja occidentalis 6C ..............Earache from pressur

The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

Uses*

INDICATIONS & USAGE SECTION

Temporarily relieves earache symptoms associated with

  • common pain and itching of swimmer's ear
  • clogged ears
  • ear pain or itching from other earaches after diagnosis by a doctor

Warnings

WARNINGS SECTION

For use in ears only.

Do not use

OTC - DO NOT USE SECTION

if you have ear tubes, a damaged eardrum, or after surgery

Stop use and ask your doctor if

OTC - STOP USE SECTION

  • symptoms persist for more than 48 hours or worsen
  • symptoms are accompanied by a fever
  • any discharge from the ear is present

If pregnant or breatfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

seek professional advice before taking this product.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake before use

adults and children ages 6 and older:

  • tilt head sideways and apply 2-3 drops into the ear (tip of dropper should not enter the ear canal)
  • keep head tilted and allow drops to remain in the ear for 2 minutes or gently place cotton in ear to keep drops in
  • repeat as needed, up to 4 times a day

Other Information

OTHER SAFETY INFORMATION

  • store in a cool dry place
  • do not use if neckband seal is torn, broken, or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

castor oil

Questions, Comments?

OTC - QUESTIONS SECTION

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Homeopathic Statements

SPL UNCLASSIFIED SECTION

*These “USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based on traditional homeopathic practices.

**C, K, CK and X are homeopathic dilutions.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DoloEar PDPDoloEar PDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-401DOLOEAR (APIS MELIFICA, ARISTOLOCHIA CLEMATITIS, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, THUJA OCCIDENTALIS) SOLUTION/ DROPS [PHARMADEL LLC]1Unmatched20231030_04cd8bf5-9758-8d87-e063-6394a90afbb7.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-40155758-401-15

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
CASTOR OILD5340Y2I9GIACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARISTOLOCHIA CLEMATITIS ROOTZY0NX0W00DACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB

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
364c8795-31b7-cb2e-e063-6394a90a9d8204cd8bf5-9758-8d87-e063-6394a90afbb72025-05-29WarningsExact identifier
spl set id: 04cd8bf5-9758-8d87-e063-6394a90afbb7

Reported adverse events (FAERS/openFDA)#

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