62106-1157 NDC - UNDA 220 (GRINDELIA, PILOCARPUS, SALVIA OFFICINALIS, SENEGA OFFICINALIS, STRAMONIUM, VALERIANA OFFICINALIS)

Drug Information

Product NDC: 62106-1157

Proprietary Name: UNDA 220

Non Proprietary Name: Grindelia, Pilocarpus, Salvia officinalis, Senega officinalis, Stramonium, Valeriana officinalis

Active Ingredient(s):
  • 6 [hp_X]/20mL DATURA STRAMONIUM;
  • 6 [hp_X]/20mL GRINDELIA HIRSUTULA FLOWERING TOP;
  • 6 [hp_X]/20mL PILOCARPUS MICROPHYLLUS LEAF;
  • 6 [hp_X]/20mL POLYGALA SENEGA ROOT;
  • 6 [hp_X]/20mL SAGE;
  • 6 [hp_X]/20mL VALERIAN


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Increased Histamine Release [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Plant Proteins [CS]

Labeler Information

Labeler Name: Seroyal USA
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/22/2015

Package Information

No. Package Code Package Description Billing Unit
162106-1157-81 BOTTLE, GLASS in 1 CARTON (62106-1157-8) / 20 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC62106-1157The 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 NAMEUNDA 220The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGrindelia, Pilocarpus, Salvia officinalis, Senega officinalis, Stramonium, Valeriana officinalisThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE9/22/2015This 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 NAMESeroyal USAName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDATURA STRAMONIUM; GRINDELIA HIRSUTULA FLOWERING TOP; PILOCARPUS MICROPHYLLUS LEAF; POLYGALA SENEGA ROOT; SAGE; VALERIANAn 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 STRENGTH6; 6; 6; 6; 6; 6 
ACTIVE INGRED UNIT[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] 

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