Home FDA labels 4604bc32-4169-9c03-e063-6394a90abae5 EarAche Relief PM openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name EarAche Relief PM
Generic name APIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALIS
Manufacturer TRP Company
Product type HUMAN OTC DRUG
SPL set ID 92ee4f15-7315-7a46-e053-2995a90a7d0a
SPL ID 4604bc32-4169-9c03-e063-6394a90abae5
Version 5
Effective date 2025-12-15
Source export date 2026-11-06
Source partition 14
Source file https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/b433ab6a44616055e476a7876dbdd70a7f81f656e17ee28dc50dad20e67316bd/drug-label-0014-of-0014.json.zip
Source manifest SHA-256 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run 20261106T075659Z
Imported at 2026-11-06 09:26:20 Harmonized routes table Harmonized routes AURICULAR (OTIC)
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 17 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name EarAche Relief PM openfda.brand_name generic name APIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALIS openfda.generic_name manufacturer name TRP Company openfda.manufacturer_name ndc package 17312-173-15 openfda.package_ndc ndc product 17312-173 openfda.product_ndc ndc11 package 17312017315 derived:openfda.package_ndc spl id 4604bc32-4169-9c03-e063-6394a90abae5 id spl set id 92ee4f15-7315-7a46-e053-2995a90a7d0a set_id unii O80TY208ZW openfda.unii unii 91D9GV0Z28 openfda.unii unii VB06AV5US8 openfda.unii unii JWF5YAW3QW openfda.unii unii 7S82P3R43Z openfda.unii unii G0R4UBI2ZZ openfda.unii unii K8F3G29S6Z openfda.unii unii 1MBW07J51Q openfda.unii unii XA8YCV5M3E openfda.unii
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings 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. Stop use and ask a doctor if: • You experience ear pain or worsening symptoms. • Symptoms last longer than 7 days.
warnings 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.