75053-0010 NDC - HYPOTHALTEM (EUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIA)

Drug Information

Product NDC: 75053-0010
Proprietary Name: Hypothaltem
Non Proprietary Name: Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (Suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria
Active Ingredient(s): 12 [hp_X]/mL BARIUM CARBONATE; 9 [hp_X]/mL BENZENE; 9 [hp_X]/mL BERBERIS VULGARIS ROOT BARK; 30 [hp_C]/mL DELPHINIUM STAPHISAGRIA SEED; 6 [hp_X]/mL EUPATORIUM PERFOLIATUM FLOWERING TOP; 30 [hp_C]/mL GELSEMIUM SEMPERVIRENS ROOT; 9 [hp_X]/mL MENTHA PULEGIUM WHOLE; 9 [hp_X]/mL MOSCHUS MOSCHIFERUS MUSK SAC RESIN; 12 [hp_C]/mL PYRIDOXINE HYDROCHLORIDE; 9 [hp_X]/mL SEPIA OFFICINALIS JUICE; 30 [hp_C]/mL SODIUM CARBONATE; 30 [hp_C]/mL STRYCHNOS NUX-VOMICA SEED; 7 [hp_C]/mL SUS SCROFA ADRENAL GLAND; 7 [hp_C]/mL SUS SCROFA HYPOTHALAMUS; 7 [hp_C]/mL SUS SCROFA PITUITARY GLAND; 7 [hp_C]/mL THYROID, UNSPECIFIED
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Allergens [CS]; Analogs/Derivatives [Chemical/Ingredient]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Vitamin B 6 [Chemical/Ingredient]; Vitamin B6 Analog [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Nucleic Products, LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	5/11/2021

Package Information

No.	Package Code	Package Description	Billing Unit
1	75053-0010-1	118 mL in 1 BOTTLE, DROPPER (75053-0010-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	75053-0010	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	Hypothaltem	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	Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (Suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria	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	5/11/2021	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	Nucleic Products, LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	BARIUM CARBONATE; BENZENE; BERBERIS VULGARIS ROOT BARK; DELPHINIUM STAPHISAGRIA SEED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MENTHA PULEGIUM WHOLE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PYRIDOXINE HYDROCHLORIDE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED	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	12; 9; 9; 30; 6; 30; 9; 9; 12; 9; 30; 30; 7; 7; 7; 7
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
PHARM CLASSES	Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]

Drug Information

Labeler Information

Package Information

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