80961-125 NDC - ALLERGY DESENSITIZATION (ONION, APIS MELLIFERA, SCHOENOCAULON OFFICINALE SEED, EUPHRASIA STRICTA)

Drug Information

Product NDC: 80961-125

Proprietary Name: Allergy Desensitization

Non Proprietary Name: Onion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia Stricta

Active Ingredient(s):
  • 6 [hp_X]/mL APIS MELLIFERA;
  • 4 [hp_X]/mL EUPHRASIA STRICTA;
  • 6 [hp_X]/mL ONION;
  • 6 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED


Administration Route(s): OPHTHALMIC

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Bee Venoms [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Standardized Insect Venom Allergenic Extract [EPC];
  • Vegetable Proteins [CS]

Labeler Information

Labeler Name: Peak Manufacturing and Fulfillment Inc
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/6/2020

Package Information

No. Package Code Package Description Billing Unit
180961-125-101 BOTTLE, DROPPER in 1 PACKAGE (80961-125-10) / 10 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name Field Value Definition
PRODUCT NDC80961-125The 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 NAMEAllergy DesensitizationThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEOnion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia StrictaThe 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 NAMEOPHTHALMICThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/6/2020This 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 NAMEPeak Manufacturing and Fulfillment IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAPIS MELLIFERA; EUPHRASIA STRICTA; ONION; SCHOENOCAULON OFFICINALE SEEDAn 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; 4; 6; 6 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS] 

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