EarAche Relief PM

Manufacturer
TRP Company
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:35:53

Label at a glance#

ProductEarAche Relief PM
Active ingredientVALERIAN, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, MATRICARIA CHAMOMILLA, APIS MELLIFERA, LOESELIA MEXICANA WHOLE, PASSIFLORA INCARNATA FLOWER, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear
Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain
Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability
Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness
Echinacea HPUS 3x...............................................Immune support
Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold
Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness
Passiflora HPUS 5x ................................................Sleep disorders, exhaustion
Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid

"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Apis mellifica HPUS - Discomfort, redness of external ear
Arnica montana HPUS - Bruised aching pain
Calcarea phosphorica HPUS - Itching, irritability
Chamomilla HPUS - Pain disturbs sleep, restlessness
Echinacea HPUS - Immune support
Hepar sulphuris calcareum - Sensitive to touch, water, wind, cold
Hoitzia HPUS - Fever, fullness
Passiflora HPUS - Sleep disorders, exhaustion
Valeriana officinalis HPUS - Relaxing, calming sleep aid

INDICATIONS & USAGE SECTION

Uses:*
• According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Discomfort • Itching, coldness, irritability • Sensitivity to water, wind and touch • Fullness, congestion • Sleeplessness; after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.


*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS SECTION

Warnings:

A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only.

  • This product is intended to complement, not replace, standard medical treatment.
  • Initial worsening of symptoms may occur.

OTC - STOP USE SECTION

Stop use and ask a doctor if: • You experience ear pain or worsening symptoms. • Symptoms last longer than 7 days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - DO NOT USE SECTION

Do not use:

  • If solution changes color or becomes cloudy.
  • If you have ear drainage, discharge, irritation, a rash in the ear or dizziness.
  • If you have ear tubes, after surgery or with damaged ear drums.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

WARNINGS SECTION

  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
  • Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

DOSAGE & ADMINISTRATION SECTION

Directions:
• Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician before use. • For use in ear only.•Use 3 to 5 drops before bedtime. • Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. • Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 20 to 40 seconds. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

SPL UNCLASSIFIED SECTION

Other information:

• Non-prescription drug products cannot treat infections. • Store at room temperature 15o to 30o C (59o to 86o F) • Keep bottle tightly closed. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • EarAche Relief ® PM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Benzalkonium Chloride, Glycerin, Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CartonCarton

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130858961001730GTIN-13: 0858961001730
EAN-13: 0858961001730
GTIN-12: 858961001730
UPC-A: 858961001730
GTIN storage (14 digits): 00858961001730
TRP_NE_EAR_DROP_CTN_1-27-23_r5_USA_F.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17312-173-15EarAche Relief PM10 mL in 1 BOTTLE, DROPPERLIQUID105
17312-173-15EarAche Relief PM1 in 1 PACKAGELIQUID15

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-17317312-173-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
EarAche Relief PMAPIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALISTRP Company92ee4f15-7315-7a46-e053-2995a90a7d0a2025-12-15WarningsExact identifier
ndc (package): 17312-173-15
ndc (product): 17312-173
ndc11 (package): 17312017315
spl id: 4604bc32-4169-9c03-e063-6394a90abae5
spl set id: 92ee4f15-7315-7a46-e053-2995a90a7d0a

Reported adverse events (FAERS/openFDA)#

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