Hypothaltem Liquid
NDC 75053-0010
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
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) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Nucleic Products, Llc. This medication is typically used as a allergens [cs]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 75053-0010 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
75053-0010
Proprietary Name:
Hypothaltem
Non-Proprietary Name: [1]
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
Substance Name: [2]
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
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Liquid
- A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
75053
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
05-11-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 75053-0010?
The NDC code 75053-0010 is assigned by the FDA to the product Hypothaltem. It is commonly known by its generic 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. This pharmaceutical product is labeled by Nucleic Products, Llc and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 75053-0010-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Homeopathic medicine for the regulation of hypothalamic function.
Homeopathic medicine for the regulation of hypothalamic function.
What are Active Ingredients of this product?
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.
- BARIUM CARBONATE 12 [hp_X]/mL
- BENZENE 9 [hp_X]/mL - Toxic, volatile, flammable liquid hydrocarbon byproduct of coal distillation. It is used as an industrial solvent in paints, varnishes, lacquer thinners, gasoline, etc. Benzene causes central nervous system damage acutely and bone marrow damage chronically and is carcinogenic. It was formerly used as parasiticide.
- BERBERIS VULGARIS ROOT BARK 9 [hp_X]/mL
- DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/mL
- EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]/mL
- GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/mL
- MENTHA PULEGIUM WHOLE 9 [hp_X]/mL
- MOSCHUS MOSCHIFERUS MUSK SAC RESIN 9 [hp_X]/mL
- PYRIDOXINE HYDROCHLORIDE 12 [hp_C]/mL - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
- SEPIA OFFICINALIS JUICE 9 [hp_X]/mL
- SODIUM CARBONATE 30 [hp_C]/mL - used topically for dermatitides, mouthwash, vaginal douche; veterinary use as emergency emetic; RN given refers to carbonic acid, di-Na salt; structure
- STRYCHNOS NUX-VOMICA SEED 30 [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 7 [hp_C]/mL
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E)
- EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (Active Moiety)
- BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)
- BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (Active Moiety)
- MENTHA PULEGIUM WHOLE (UNII: 5Q6Y7K4846)
- MENTHA PULEGIUM WHOLE (UNII: 5Q6Y7K4846) (Active Moiety)
- MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7)
- MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (Active Moiety)
- BENZENE (UNII: J64922108F)
- BENZENE (UNII: J64922108F) (Active Moiety)
- SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2)
- SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (Active Moiety)
- BARIUM CARBONATE (UNII: 6P669D8HQ8)
- BARIUM CATION (UNII: V645272HLN) (Active Moiety)
- SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV)
- SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (Active Moiety)
- SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT)
- SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (Active Moiety)
- SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79)
- SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (Active Moiety)
- THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P)
- THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (Active Moiety)
- PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
- PYRIDOXINE (UNII: KV2JZ1BI6Z) (Active Moiety)
- GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q)
- GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (Active Moiety)
- SODIUM CARBONATE (UNII: 45P3261C7T)
- CARBONATE ION (UNII: 7UJQ5OPE7D) (Active Moiety)
- STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919)
- STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (Active Moiety)
- DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV)
- DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
- ALCOHOL (UNII: 3K9958V90M)
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
- Allergens - [CS]
- Analogs/Derivatives - [Chemical/Ingredient]
- Cell-mediated Immunity - [PE] (Physiologic Effect)
- Increased Histamine Release - [PE] (Physiologic Effect)
- Increased IgG Production - [PE] (Physiologic Effect)
- Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Plant Proteins - [CS]
- Seed Storage Proteins - [CS]
- Vitamin B 6 - [Chemical/Ingredient]
- Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? 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.
What kind of product is this? 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
