OPSONAT

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:35

Label at a glance#

ProductOPSONAT
Active ingredientSILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS WHOLE, LYTTA VESICATORIA, GRATIOLA OFFICINALIS WHOLE, GOLDENSEAL, LACHESIS MUTA VENOM, GLECHOMA HEDERACEA FLOWERING TOP
Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ingredients:
Acidum nitricum6X
Acidum sulfuricum6X
Gratiola officinalis4X
Hydrastis canadensis5X
Lachesis muta8X
Lytta vesicatoria (Cantharis)4X
Bellis perennis1X
Glechoma hederacea16.02 mg/ml

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT SECTION

Contains 24% alcohol by volume.

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use this product if tamper evident strip is broken or removed from base of cap.

OTC - QUESTIONS SECTION

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OPSONAT™

Oral Drops

Homeopathic Medicine

For relief of minor
mucous membrane
inflammation, such
as the mouth

3.34 FL OZ
(100 ml)

PEKANA®

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-313-10OPSONAT50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-313-10OPSONAT1 in 1 BOXSOLUTION/ DROPS12
59469-313-40OPSONAT100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1002
59469-313-40OPSONAT1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-313OPSONAT (SILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS, LYTTA VESICATORIA, GRATIOLA OFFICINALIS, GOLDENSEAL, LACHESIS MUTA VENOM, AND GLECHOMA HEDERACEA FLOWERING TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 4 package rows20230113_506f8227-207c-462c-a71c-5f8f00b4f8de.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-31359469-313-40, 59469-313-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPSONATSILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS, LYTTA VESICATORIA, GRATIOLA OFFICINALIS, GOLDENSEAL, LACHESIS MUTA VENOM, AND GLECHOMA HEDERACEA FLOWERING TOPPEKANA Naturheilmittel GmbH506f8227-207c-462c-a71c-5f8f00b4f8de2023-01-11WarningsExact identifier
ndc (package): 59469-313-10
ndc (package): 59469-313-40
ndc (product): 59469-313
ndc11 (package): 59469031310
ndc11 (package): 59469031340
spl id: 78966d8c-4e59-42a5-b818-a4f191e94ae0
spl set id: 506f8227-207c-462c-a71c-5f8f00b4f8de

Reported adverse events (FAERS/openFDA)#

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