Ototone

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: Ototone
Generic name: BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)
Manufacturer: Energique, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c34e0abf-02d8-4dee-a89b-3f61ab593dc3
SPL ID: 16dcd12c-ba0d-4cb5-afec-6de76a1bbfae
Version: 3
Effective date: 2024-10-29
Source export date: 2026-10-27
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/2026-10-27/9122bd1bdced046e8f62ea012d80757473b7d83ea1faeea61faef490e06fd630/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 21:09:48

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		Ototone	openfda.brand_name
generic name		BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)	openfda.generic_name
manufacturer name		Energique, Inc.	openfda.manufacturer_name
ndc	package	44911-0467-1	openfda.package_ndc
ndc	product	44911-0467	openfda.product_ndc
ndc11	package	44911046701	derived:openfda.package_ndc
spl id		16dcd12c-ba0d-4cb5-afec-6de76a1bbfae	id
spl set id		c34e0abf-02d8-4dee-a89b-3f61ab593dc3	set_id
unii		11E6VI8VEG	openfda.unii
unii		324Y4038G2	openfda.unii
unii		2E32821G6I	openfda.unii
unii		91GQH8I5F7	openfda.unii
unii		VB06AV5US8	openfda.unii
unii		8E272251DI	openfda.unii
unii		ZW3Z11D0JV	openfda.unii
unii		WQZ3G9PF0H	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: 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.