65808-322 NDC - REAL RELIEF (CHAMOMILA, COFFEA CRUDA, ERIODICTYON CALIFORNICUM, HISTAMINUM, IPECACUANHA, LOBELIA INFLATA, SAMBUCUS NIGRA, SOLIDAGO VIRGAUREA)

Drug Information

Product NDC: 65808-322

Proprietary Name: Real Relief

Non Proprietary Name: Chamomila, Coffea Cruda, Eriodictyon californicum, Histaminum, Ipecacuanha, Lobelia inflata, Sambucus nigra, Solidago virgaurea

Active Ingredient(s):
  • 8 [hp_X]/1 ARABICA COFFEE BEAN;
  • 8 [hp_X]/1 ERIODICTYON CALIFORNICUM LEAF;
  • 8 [hp_X]/1 HISTAMINE DIHYDROCHLORIDE;
  • 8 [hp_X]/1 IPECAC;
  • 8 [hp_X]/1 LOBELIA INFLATA;
  • 8 [hp_X]/1 MATRICARIA CHAMOMILLA;
  • 8 [hp_X]/1 SAMBUCUS NIGRA FLOWERING TOP;
  • 8 [hp_X]/1 SOLIDAGO VIRGAUREA FLOWERING TOP


Administration Route(s): ORAL

Dosage Form(s): TABLET

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];
  • Seed Storage Proteins [CS]

Labeler Information

Labeler Name: GMP Laboratories of America, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/1/2020

Package Information

No. Package Code Package Description Billing Unit
165808-322-011 BOTTLE in 1 CARTON (65808-322-01) / 90 TABLET in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC65808-322The 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 NAMEReal ReliefThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEChamomila, Coffea Cruda, Eriodictyon californicum, Histaminum, Ipecacuanha, Lobelia inflata, Sambucus nigra, Solidago virgaureaThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE1/1/2020This 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 NAMEGMP Laboratories of America, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; MATRICARIA CHAMOMILLA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOPAn 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 STRENGTH8; 8; 8; 8; 8; 8; 8; 8 
ACTIVE INGRED UNIT[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 
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], Seed Storage Proteins [CS] 

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