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#
Contacts and useful links#
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
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.
Questions or comments?
www.thereliefproducts.com, 1-888-969-6855
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0858961001730 | GTIN-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 | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17312-173-15 | EarAche Relief PM | 10 mL in 1 BOTTLE, DROPPER | LIQUID | 10 | 5 | |
| 17312-173-15 | EarAche Relief PM | 1 in 1 PACKAGE | LIQUID | 1 | 5 |
Products#
Every source-derived product name is available through these pages.
- EarAche Relief PM
- Apis mellifica, Arnica montana, Calcarea phosphorica, Chamomilla,Echinacea, Hepar sulphuris calcareum, Hoitzia, Passiflora, Valeriana officinalis
- BENZALKONIUM CHLORIDE
- VALERIAN
- GLYCERIN
- WATER
- ARNICA MONTANA
- ECHINACEA ANGUSTIFOLIA
- MATRICARIA CHAMOMILLA
- APIS MELLIFERA
- LOESELIA MEXICANA WHOLE
- PASSIFLORA INCARNATA FLOWER
- TRIBASIC CALCIUM PHOSPHATE
- PHOSPHATE ION
- CALCIUM SULFIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 17312-173 | 17312-173-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| VALERIAN | JWF5YAW3QW | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| ECHINACEA ANGUSTIFOLIA | VB06AV5US8 | ACTIB |
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | ACTIB |
| LOESELIA MEXICANA WHOLE | XA8YCV5M3E | ACTIB |
| PASSIFLORA INCARNATA FLOWER | K8F3G29S6Z | ACTIB |
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EarAche Relief PM | APIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALIS | TRP Company | 92ee4f15-7315-7a46-e053-2995a90a7d0a | 2025-12-15 | Warnings | 17312-173-15 17312-173 17312017315 4604bc32-4169-9c03-e063-6394a90abae5 92ee4f15-7315-7a46-e053-2995a90a7d0a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

