63479-0603 NDC - F03 (ASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINE)

Drug Information

Product NDC: 63479-0603

Proprietary Name: F03

Non Proprietary Name: ASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINE

Active Ingredient(s):
  • 12 [hp_C]/mL AESCULUS CARNEA FLOWER;
  • 12 [hp_C]/mL ALLIUM SATIVUM WHOLE;
  • 20 [hp_C]/mL ARSENIC TRIOXIDE;
  • 12 [hp_C]/mL DIPLACUS AURANTIACUS WHOLE;
  • 12 [hp_C]/mL ERIOBOTRYA JAPONICA WHOLE;
  • 20 [hp_C]/mL GELSEMIUM SEMPERVIRENS ROOT;
  • 12 [hp_C]/mL HELIANTHEMUM NUMMULARIUM FLOWER;
  • 20 [hp_C]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING;
  • 12 [hp_C]/mL LUFFA OPERCULATA FRUIT;
  • 12 [hp_C]/mL MIMULUS GUTTATUS FLOWERING TOP;
  • 12 [hp_C]/mL PENSTEMON DAVIDSONII WHOLE;
  • 12 [hp_C]/mL POPULUS TREMULA FLOWERING TOP;
  • 12 [hp_C]/mL PRUNUS CERASIFERA FLOWER;
  • 12 [hp_C]/mL RUBUS URSINUS WHOLE;
  • 12 [hp_C]/mL TOXICODENDRON DIVERSILOBUM WHOLE;
  • 12 [hp_C]/mL VIOLA ODORATA FLOWER;
  • 12 [hp_C]/mL WATERMELON


Administration Route(s): SUBLINGUAL

Dosage Form(s): SOLUTION/ DROPS

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

Labeler Information

Labeler Name: Apex Energetics Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/12/1996

Package Information

No. Package Code Package Description Billing Unit
163479-0603-130 mL in 1 BOTTLE, GLASS (63479-0603-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC63479-0603The 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 NAMEF03The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXFR-RLSA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINEThe 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 NAMESUBLINGUALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/12/1996This 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 NAMEApex Energetics Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAESCULUS CARNEA FLOWER; ALLIUM SATIVUM WHOLE; ARSENIC TRIOXIDE; DIPLACUS AURANTIACUS WHOLE; ERIOBOTRYA JAPONICA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHEMUM NUMMULARIUM FLOWER; LILIUM LANCIFOLIUM WHOLE FLOWERING; LUFFA OPERCULATA FRUIT; MIMULUS GUTTATUS FLOWERING TOP; PENSTEMON DAVIDSONII WHOLE; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; RUBUS URSINUS WHOLE; TOXICODENDRON DIVERSILOBUM WHOLE; VIOLA ODORATA FLOWER; WATERMELONAn 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 STRENGTH12; 12; 20; 12; 12; 20; 12; 20; 12; 12; 12; 12; 12; 12; 12; 12; 12 
ACTIVE INGRED UNIT[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC] 

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