DoloEar

Manufacturer: Pharmadel LLC
Effective date: 2023-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 21:21:03

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 children under 6 years of age : do not use

Contacts and useful links#

PhoneLabel contact+1-866-359-3478

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.........	Ear inflammation
Belladonna 6C..........................	Throbbing pain
Chamomilla vulgaris 6C ..........	Ear pain irritability
Lachesis mutus 6C ..................	Ear inflammation
Thuja occidentalis 6C ..............	Earache from pressure

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

children under 6 years of age: do not use

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

glycerin, water

Distributed by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC.
New Castle DE, 19720

+1-866-359-3478

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 PDP HC

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-327	DOLOEAR (APIS MELIFICA, ARISTOLOCHIA CLEMATITIS, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, THUJA OCCIDENTALIS) SOLUTION/ DROPS [PHARMADEL LLC]	8	Legacy NDC	20231114_cfbf183d-962b-2e66-e053-2995a90a12d5.zip

Products#

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

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

DoloEar
Apis Melifica, Aristolochia Clematitis, Belladonna, Chamomilla, Lachesis Mutus, Thuja Occidentalis
GLYCERIN
WATER
ATROPA BELLADONNA
APIS MELLIFERA
ARISTOLOCHIA CLEMATITIS ROOT
LACHESIS MUTA VENOM
THUJA OCCIDENTALIS LEAFY TWIG
MATRICARIA CHAMOMILLA
MATRICARIA RECUTITA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-327	55758-327-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
APIS MELLIFERA	7S82P3R43Z	ACTIB
ARISTOLOCHIA CLEMATITIS ROOT	ZY0NX0W00D	ACTIB
LACHESIS MUTA VENOM	VSW71SS07I	ACTIB
THUJA OCCIDENTALIS LEAFY TWIG	1NT28V9397	ACTIB
MATRICARIA CHAMOMILLA	G0R4UBI2ZZ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
369ae719-25b1-a6f8-e063-6294a90a9d87			cfbf183d-962b-2e66-e053-2995a90a12d5	2025-06-02	Warnings	Exact identifier spl set id: cfbf183d-962b-2e66-e053-2995a90a12d5

Reported adverse events (FAERS/openFDA)#

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