Home NDC 75053-0010 Hypothaltem
Product NDC 75053-0010
11-digit product format 750530010
Labeler code 75053
Product ID 75053-0010_4e326cd0-c586-4d82-80ef-0ae5dd294dcc
Type HUMAN OTC DRUG
Nonproprietary 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
Dosage form LIQUID
Route ORAL
Labeler Nucleic Products, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-05-11
Substance EUPATORIUM PERFOLIATUM FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MENTHA PULEGIUM WHOLE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; BENZENE; SEPIA OFFICINALIS JUICE; BARIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, UNSPECIFIED; PYRIDOXINE HYDROCHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED
Active strength 6; 9; 9; 9; 9; 9; 12; 7; 7; 7; 7; 12; 30; 30; 30; 30 [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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hypothaltem
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]/mL BERBERIS VULGARIS ROOT BARK 9 [hp_X]/mL MENTHA PULEGIUM WHOLE 9 [hp_X]/mL MOSCHUS MOSCHIFERUS MUSK SAC RESIN 9 [hp_X]/mL BENZENE 9 [hp_X]/mL SEPIA OFFICINALIS JUICE 9 [hp_X]/mL BARIUM CARBONATE 12 [hp_X]/mL SUS SCROFA ADRENAL GLAND 7 [hp_C]/mL SUS SCROFA PITUITARY GLAND 7 [hp_C]/mL SUS SCROFA HYPOTHALAMUS 7 [hp_C]/mL THYROID, UNSPECIFIED 7 [hp_C]/mL PYRIDOXINE HYDROCHLORIDE 12 [hp_C]/mL GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/mL SODIUM CARBONATE 30 [hp_C]/mL STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 16 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75053-0010-1 Hypothaltem 118 mL in 1 BOTTLE, DROPPER LIQUID 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75053-0010 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) LIQUID [NUCLEIC PRODUCTS, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20250322_b95050f2-f40d-4e84-8752-4d7ad75390c9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Nucleic Products, LLC b95050f2-f40d-4e84-8752-4d7ad75390c9 2025-03-20 Warnings Exact identifier ndc (product): 75053-0010
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75053-0010-1 75053001001 118 mL in 1 BOTTLE, DROPPER (75053-0010-1) 118 ml 2021-05-11 0000-00-00 No No Current