Home FDA labels b1b1bae2-148d-43f0-a7fe-f35c19a1bd31 Otoflam HP 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 Otoflam HP
Generic name BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.
Manufacturer Energique, Inc.
Product type HUMAN OTC DRUG
SPL set ID 76c6b494-43d1-4508-bea4-4f9026b4a5fa
SPL ID b1b1bae2-148d-43f0-a7fe-f35c19a1bd31
Version 3
Effective date 2024-10-29
Source export date 2026-09-28
Source partition 2
Source file https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:15:20 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 Otoflam HP openfda.brand_name generic name BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA. openfda.generic_name manufacturer name Energique, Inc. openfda.manufacturer_name ndc package 44911-0513-1 openfda.package_ndc ndc product 44911-0513 openfda.product_ndc ndc11 package 44911051301 derived:openfda.package_ndc spl id b1b1bae2-148d-43f0-a7fe-f35c19a1bd31 id spl set id 76c6b494-43d1-4508-bea4-4f9026b4a5fa set_id unii KPS1B1162N openfda.unii unii 324Y4038G2 openfda.unii unii Q28R5GF371 openfda.unii unii ETJ7Z6XBU4 openfda.unii unii DSV74G1P2J openfda.unii unii 91GQH8I5F7 openfda.unii unii 8E272251DI openfda.unii unii T4423S18FM openfda.unii unii G0R4UBI2ZZ openfda.unii unii 1MBW07J51Q 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: If pregnant or breast-feeding, ask a health 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.