59469-313 NDC - OPSONAT (SILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS, LYTTA VESICATORIA, GRATIOLA OFFICINALIS, GOLDENSEAL, LACHESIS MUTA VENOM, AND GLECHOMA HEDERACEA FLOWERING TOP)

Drug Information

Product NDC: 59469-313

Proprietary Name: OPSONAT

Non Proprietary Name: silver nitrate, sulfuric acid, bellis perennis, lytta vesicatoria, gratiola officinalis, goldenseal, lachesis muta venom, and glechoma hederacea flowering top

Active Ingredient(s):
  • 1 [hp_X]/100mL BELLIS PERENNIS WHOLE;
  • 1602 mg/100mL GLECHOMA HEDERACEA FLOWERING TOP;
  • 5 [hp_X]/100mL GOLDENSEAL;
  • 4 [hp_X]/100mL GRATIOLA OFFICINALIS WHOLE;
  • 8 [hp_X]/100mL LACHESIS MUTA VENOM;
  • 4 [hp_X]/100mL LYTTA VESICATORIA;
  • 6 [hp_X]/100mL SILVER NITRATE;
  • 6 [hp_X]/100mL SULFURIC ACID


Administration Route(s): ORAL

Dosage Form(s): SOLUTION/ DROPS

Labeler Information

Labeler Name: PEKANA Naturheilmittel GmbH
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:6/24/2019

Package Information

No. Package Code Package Description Billing Unit
159469-313-101 BOTTLE, GLASS in 1 BOX (59469-313-10) / 50 mL in 1 BOTTLE, GLASS
259469-313-401 BOTTLE, GLASS in 1 BOX (59469-313-40) / 100 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-313The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEOPSONATThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEsilver nitrate, sulfuric acid, bellis perennis, lytta vesicatoria, gratiola officinalis, goldenseal, lachesis muta venom, and glechoma hederacea flowering topThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEPEKANA Naturheilmittel GmbHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBELLIS PERENNIS WHOLE; GLECHOMA HEDERACEA FLOWERING TOP; GOLDENSEAL; GRATIOLA OFFICINALIS WHOLE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; SILVER NITRATE; SULFURIC ACIDAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH1; 1602; 5; 4; 8; 4; 6; 6 
ACTIVE INGRED UNIT[hp_X]/100mL; mg/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 

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This page was last updated on: 2/1/2023