FDA label b52e2115-f703-477e-9419-1122228d9151

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)

SPL set ID: f5488c09-e06c-4223-bc35-db7d533ed897
SPL ID: b52e2115-f703-477e-9419-1122228d9151
Version: 7
Effective date: 2021-03-24
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:49:57

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 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b52e2115-f703-477e-9419-1122228d9151	id
spl set id		f5488c09-e06c-4223-bc35-db7d533ed897	set_id

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

Medicamento Homeopatico. Mantengase fuera del alcance de los ninos. DIRECTIONS: Shake 10 times before use. Hold close to mouth and spray 3 times directly under the tongue every 15 minutes, extend interval as symptoms improve or as directed by a health care professional. Manufactured according to HPUS standards. CONDICIONES DE ALMACENAMIENTO: Conservar el producto protegido del calor, luz y humedad. Alcamacenar a no mas de 30C. INACTIVE INGREDIENTS: USP Ethanol Alcohol 20% Mfg. By: OHM PHARMA INC. Mineral Wells, TX 76067 R.S. INVIMA: MH2010-0001531 Importado y Distribuido para Colombia por: OHM PHARMA COLOMBIA Ltda. DG. 39 NO 34 C SUR 30 Envigado, Antioquia Tel: (57) 4-379 5995

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.