FDA.reportPublic FDA data

OPSONAT

Product NDC
59469-313
11-digit product format
594690313
Labeler code
59469
Product ID
59469-313_78966d8c-4e59-42a5-b818-a4f191e94ae0
Type
HUMAN OTC DRUG
Nonproprietary name
silver nitrate, sulfuric acid, bellis perennis, lytta vesicatoria, gratiola officinalis, goldenseal, lachesis muta venom, and glechoma hederacea flowering top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
BELLIS PERENNIS WHOLE; GLECHOMA HEDERACEA FLOWERING TOP; GOLDENSEAL; GRATIOLA OFFICINALIS WHOLE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; SILVER NITRATE; SULFURIC ACID
Active strength
1; 1602; 5; 4; 8; 4; 6; 6 [hp_X]/100mL; mg/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OPSONAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER NITRATE1 [hp_X]/100mL
SULFURIC ACID1602 mg/100mL
BELLIS PERENNIS WHOLE5 [hp_X]/100mL
LYTTA VESICATORIA4 [hp_X]/100mL
GRATIOLA OFFICINALIS WHOLE8 [hp_X]/100mL
GOLDENSEAL4 [hp_X]/100mL
LACHESIS MUTA VENOM6 [hp_X]/100mL
GLECHOMA HEDERACEA FLOWERING TOP6 [hp_X]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95IT3W8JZEInternal UNII lookup
O40UQP6WCFInternal UNII lookup
2HU33I03UYInternal UNII lookup
3Q034RO3BTInternal UNII lookup
BDD9991A36Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
VSW71SS07IInternal UNII lookup
2458J91U39Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
506f8227-207c-462c-a71c-5f8f00b4f8deAvailable on FDA.report

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

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 (product): 59469-313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-313-10594690313101 BOTTLE, GLASS in 1 BOX (59469-313-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent
59469-313-40594690313401 BOTTLE, GLASS in 1 BOX (59469-313-40) / 100 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent