FDA.reportPublic FDA data

Hyland's Earache Drops

Manufacturer
Hyland's Inc.
Effective date
2026-08-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-08-27 00:01:33

Label at a glance#

ProductHylands Naturals Earache Drops
Active ingredientCHAMOMILE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA PATENS WHOLE, SULFUR, CALCIUM CARBONATE, BELLADONNA LEAF
Label structure9 sections

Indications and uses

Temporarily relieves: ■ common pain or itching from swimmer’s ear ■ clogged ears ■ ear pain or itching from other earaches, after diagnosis by a physician

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)ear pain
Calcarea Carbonica 30C HPUSear pain, sensitivity to cold
Chamomilla 30C HPUSear pain, sensitivity to
drafts, plugged ears
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching
Sulphur 30C HPUSear pain with burning,
sensitivity to water

HPUS" is the Homeopathic Pharmacopoeia of the
United States.

Uses*

INDICATIONS & USAGE SECTION

Temporarily relieves:
■ common pain or itching from swimmer’s ear
■ clogged ears
■ ear pain or itching from other earaches,
after diagnosis by a physician

Warnings

WARNINGS SECTION

Keep away from eyes.

OTC - DO NOT USE SECTION

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if:
■ symptoms persist for more than 48 hours or worsen.
■ any discharge from ear is present.
■ symptoms are accompanied by a fever.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children ages
4 years and over:
■ Tilt head sideways and apply
3-4 drops into involved ear
(tip of applicator should not
enter ear canal).
■ Keep head tilted for at least
2 minutes to keep drops in ear.
■ Repeat until relieved, up to
4 times per day.
■ Use as directed.
■ Do not refrigerate.
■ Shake well before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Purified Water.

OTHER SAFETY INFORMATION

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

OTC - PURPOSE SECTION

Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

Earache Drops 0.33 FL. OZ. (10 mL)

EARS000L0.33CTNH3EARS000L0.33CTNH3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-412454973-4124-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILEFGL3685T2XACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PULSATILLA PATENS WHOLE4M1169RWJDACTIB
SULFUR70FD1KFU70ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
BELLADONNA LEAF6GZW20TIOIACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-05-14full-release2026-06-01 02:38:38

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
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
ndc (package): 54973-4124-1
ndc (product): 54973-4124
ndc11 (package): 54973412401
spl id: 59d42624-de71-d5fa-e063-6394a90a7363
spl set id: 017ed754-9fe8-2cb5-e063-6294a90ab2f6

Reported adverse events (FAERS/openFDA)#

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