44911-0500 NDC - MELATONIN PRO (CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS))

Drug Information

Product NDC: 44911-0500

Proprietary Name: Melatonin Pro

Non Proprietary Name: Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis)

Active Ingredient(s):
  • 12 [hp_X]/1 ANAMIRTA COCCULUS SEED;
  • 12 [hp_X]/1 ANEMONE PRATENSIS;
  • 12 [hp_X]/1 ARABICA COFFEE BEAN;
  • 12 [hp_X]/1 DIBASIC POTASSIUM PHOSPHATE;
  • 12 [hp_X]/1 FERROSOFERRIC PHOSPHATE;
  • 12 [hp_X]/1 MAGNESIUM CARBONATE;
  • 12 [hp_X]/1 MATRICARIA CHAMOMILLA;
  • 12 [hp_X]/1 MELATONIN;
  • 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE;
  • 12 [hp_X]/1 SODIUM CHLORIDE;
  • 12 [hp_X]/1 STRYCHNOS NUX-VOMICA SEED


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [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];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Plant Proteins [CS];
  • Plant Proteins [CS];
  • Seed Storage Proteins [CS];
  • Seed Storage Proteins [CS]

Labeler Information

Labeler Name: Energique, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:6/7/2019
End Marketing Date:6/19/2024

Package Information

No. Package Code Package Description Billing Unit
144911-0500-160 TABLET in 1 BOTTLE, PLASTIC (44911-0500-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC44911-0500The 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 NAMEMelatonin ProThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECalcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis)The 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 DATE6/7/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE6/19/2024This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NAMEEnergique, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANAMIRTA COCCULUS SEED; ANEMONE PRATENSIS; ARABICA COFFEE BEAN; DIBASIC POTASSIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM CARBONATE; MATRICARIA CHAMOMILLA; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA 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 STRENGTH12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 
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; [hp_X]/1; [hp_X]/1; [hp_X]/1 
PHARM CLASSESAllergens [CS], Allergens [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], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS] 

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