Home FDA labels 64379f2e-0201-42b6-924d-a8d1ee244531 Ear 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 Ear
Generic name BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)
Manufacturer BioActive Nutritional, Inc.
Product type HUMAN OTC DRUG
SPL set ID 82774eed-a906-4a19-86d9-05ea1462bd61
SPL ID 64379f2e-0201-42b6-924d-a8d1ee244531
Version 3
Effective date 2026-03-18
Source export date 2026-10-12
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:40:08 Harmonized routes table Harmonized routes ORAL
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 · 18 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name Ear openfda.brand_name generic name BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS) openfda.generic_name manufacturer name BioActive Nutritional, Inc. openfda.manufacturer_name ndc package 43857-0539-1 openfda.package_ndc ndc product 43857-0539 openfda.product_ndc ndc11 package 43857053901 derived:openfda.package_ndc spl id 64379f2e-0201-42b6-924d-a8d1ee244531 id spl set id 82774eed-a906-4a19-86d9-05ea1462bd61 set_id unii 00UK7646FG openfda.unii unii 11E6VI8VEG openfda.unii unii W2469WNO6U openfda.unii unii 91GQH8I5F7 openfda.unii unii VB06AV5US8 openfda.unii unii 660YQ98I10 openfda.unii unii 8E272251DI openfda.unii unii ZW3Z11D0JV openfda.unii unii 5EF0HWI5WU openfda.unii unii G0R4UBI2ZZ openfda.unii
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS: Sore Throat Warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.