63479-2304 NDC - W04 (AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM)

Drug Information

  • Product NDC: 63479-2304
  • Proprietary Name: W04
  • Non Proprietary Name: AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM
  • Active Ingredient(s): 1 [hp_X]/mL AMERICAN GINSENG; 1 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 12 [hp_X]/mL COFFEA ARABICA SEED, ROASTED; 1 [hp_X]/mL ESCHSCHOLZIA CALIFORNICA; 1 [hp_X]/mL GLYCYRRHIZA GLABRA; 1 [hp_X]/mL HOPS; 3 [hp_X]/mL HYPERICUM PERFORATUM; 3 [hp_X]/mL MATRICARIA CHAMOMILLA; 1 [hp_X]/mL PASSIFLORA INCARNATA TOP; 10 [hp_X]/mL PHOSPHORUS; 9 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC; 12 [hp_X]/mL PULSATILLA VULGARIS; 1 [hp_X]/mL VALERIAN; 12 [hp_X]/mL ZINC VALERATE DIHYDRATE
  • Administration Route(s): SUBLINGUAL
  • Dosage Form(s): SOLUTION/ DROPS
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Potassium Compounds [CS]; Potassium Salt [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Apex Energetics Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/15/1994

Package Information

No. Package Code Package Description Billing Unit
163479-2304-160 mL in 1 BOTTLE, GLASS (63479-2304-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC63479-2304The 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 NAMEW04The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXNEUROCALMA 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 NAMEAMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUMThe 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 DATE8/15/1994This 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 NAMEAMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; ESCHSCHOLZIA CALIFORNICA; GLYCYRRHIZA GLABRA; HOPS; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA; PASSIFLORA INCARNATA TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; VALERIAN; ZINC VALERATE DIHYDRATEAn 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 STRENGTH1; 1; 12; 1; 1; 1; 3; 3; 1; 10; 9; 12; 1; 12 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC] 

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This page was last updated on: 12/6/2025

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