50845-0260 NDC - VITAL MALE SEXUAL ENERGY (ARNICA MONTANA, AVENA SATIVA, CALADIUM SEGUINUM, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, NUPHAR LUTEUM, ORCHITINUM, PANAX GINSENG, PHOSPHORICUM ACIDUM, POPULUS TREMULOIDES, TESTOSTERONE, THUJA OCCIDENTALIS, THYMUS SUIS, THYROIDINUM SUIS)

Drug Information

Product NDC: 50845-0260
Proprietary Name: Vital Male Sexual Energy
Non Proprietary Name: Arnica Montana, Avena Sativa, Caladium Seguinum, Carduus Marianus, Damiana, Galium Aparine, Glandula Suprarenalis Suis, Hepar Suis, Hypophysis Suis, Lycopodium Clavatum, Nuphar Luteum, Orchitinum, Panax Ginseng, Phosphoricum Acidum, Populus Tremuloides, Testosterone, Thuja Occidentalis, Thymus Suis, Thyroidinum Suis
Active Ingredient(s): 3 [hp_X]/mL ARNICA MONTANA WHOLE; 1 [hp_X]/mL ASIAN GINSENG; 3 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 6 [hp_X]/mL DIEFFENBACHIA SEGUINE WHOLE; 3 [hp_X]/mL GALIUM APARINE WHOLE; 6 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 3 [hp_X]/mL MILK THISTLE; 2 [hp_X]/mL NUPHAR LUTEUM ROOT; 200 [hp_C]/mL PHOSPHORIC ACID; 1 [hp_X]/mL POPULUS TREMULOIDES BARK; 1 [hp_X]/mL POPULUS TREMULOIDES LEAF; 6 [hp_X]/mL PORK LIVER; 12 [hp_X]/mL SUS SCROFA ADRENAL GLAND; 12 [hp_X]/mL SUS SCROFA PITUITARY GLAND; 6 [hp_X]/mL SUS SCROFA TESTICLE; 6 [hp_X]/mL SUS SCROFA THYMUS; 30 [hp_X]/mL TESTOSTERONE; 200 [hp_C]/mL THUJA OCCIDENTALIS LEAFY TWIG; 12 [hp_X]/mL THYROID; 1 [hp_X]/mL TURNERA DIFFUSA LEAFY TWIG
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Androgen Receptor Agonists [MoA]; Androgen [EPC]; Androstanes [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Liddell Laboratories, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	3/25/2020
DEA Schedule:	CIII

Package Information

No.	Package Code	Package Description	Billing Unit
1	50845-0260-2	1 BOTTLE, SPRAY in 1 CARTON (50845-0260-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0260-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	50845-0260	The 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 NAME	HUMAN OTC DRUG	Indicates 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 NAME	Vital Male Sexual Energy	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Arnica Montana, Avena Sativa, Caladium Seguinum, Carduus Marianus, Damiana, Galium Aparine, Glandula Suprarenalis Suis, Hepar Suis, Hypophysis Suis, Lycopodium Clavatum, Nuphar Luteum, Orchitinum, Panax Ginseng, Phosphoricum Acidum, Populus Tremuloides, Testosterone, Thuja Occidentalis, Thymus Suis, Thyroidinum Suis	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/25/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product 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 NAME	Liddell Laboratories, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ARNICA MONTANA WHOLE; ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE WHOLE; GALIUM APARINE WHOLE; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; NUPHAR LUTEUM ROOT; PHOSPHORIC ACID; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PORK LIVER; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TURNERA DIFFUSA LEAFY TWIG	An 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 STRENGTH	3; 1; 3; 6; 3; 6; 3; 2; 200; 1; 1; 6; 12; 12; 6; 6; 30; 200; 12; 1
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_C]/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_C]/mL; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA SCHEDULE	CIII	This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Drug Information

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