MedPath

Hylands Naturals Earache Drops

Hyland's Earache Drops

Approved
Approval ID

017ed754-9fe8-2cb5-e063-6294a90ab2f6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

Hyland's Inc.

DUNS: 008316655

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54973-4124
Product Classification
G
Generic Name
belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (9)

PULSATILLA PATENS WHOLEActive
Quantity: 30 [hp_C] in 1 mL
Code: 4M1169RWJD
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SULFURActive
Quantity: 30 [hp_C] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 30 [hp_C] in 1 mL
Code: H0G9379FGK
Classification: ACTIB
CHAMOMILEActive
Quantity: 30 [hp_C] in 1 mL
Code: FGL3685T2X
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 30 [hp_C] in 1 mL
Code: C88X29Y479
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BELLADONNA LEAFActive
Quantity: 30 [hp_C] in 1 mL
Code: 6GZW20TIOI
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/27/2023

Principal Display Panel

Hyland's

Earache Drops 0.33 FL. OZ. (10 mL)

EARS000L0.33CTNH2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/27/2023

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/27/2023

***CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL

EVIDENCE. NOT FDA EVALUATED.**

WARNINGS SECTION

LOINC: 34071-1Updated: 7/27/2023

Warnings

Keep away from eyes.

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

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.

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

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/27/2023

Inactive ingredients

Citric Acid, Glycerine, Purified Water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/27/2023

Questions?

www.hylands.com
or care@hylands.com

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/27/2023

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/27/2023

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Hylands Naturals Earache Drops - FDA Drug Approval Details