63388-918 NDC - REAL RELIEF (DROSERA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM)

Drug Information

Product NDC: 63388-918

Proprietary Name: Real Relief

Non Proprietary Name: DROSERA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM

Active Ingredient(s):
  • 3 [hp_C]/100mL ARNICA MONTANA;
  • 3 [hp_C]/100mL BRYONIA ALBA WHOLE;
  • 1 [hp_C]/100mL CETRARIA ISLANDICA SUBSP. ISLANDICA;
  • 3 [hp_C]/100mL CORALLIUM RUBRUM WHOLE;
  • 1 [hp_C]/100mL DROSERA ROTUNDIFOLIA FLOWERING TOP;
  • 3 [hp_C]/100mL IPECAC;
  • 3 [hp_C]/100mL PROTORTONIA CACTI;
  • 3 [hp_C]/100mL TIN


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Laboratoire Atlas Inc
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/3/2018

Package Information

No. Package Code Package Description Billing Unit
163388-918-5430 mL in 1 BOTTLE (63388-918-54)
263388-918-551 BOTTLE in 1 CARTON (63388-918-55) / 100 mL in 1 BOTTLE
363388-918-591 BOTTLE in 1 CARTON (63388-918-59) / 250 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC63388-918The 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 NAMEDROSERA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUMThe 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 DATE3/3/2018This 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 NAMELaboratoire Atlas IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; CORALLIUM RUBRUM WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PROTORTONIA CACTI; TINAn 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 STRENGTH3; 3; 1; 3; 1; 3; 3; 3 
ACTIVE INGRED UNIT[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 

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