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
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
Active strength
12; 9; 9; 30; 6; 30; 9; 9; 12; 9; 30; 30; 7; 7; 7; 7 [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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Hypothaltem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BARIUM CARBONATE12 [hp_X]/mL
BENZENE9 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK9 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED30 [hp_C]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]/mL
MENTHA PULEGIUM WHOLE9 [hp_X]/mL
MOSCHUS MOSCHIFERUS MUSK SAC RESIN9 [hp_X]/mL
PYRIDOXINE HYDROCHLORIDE12 [hp_C]/mL
SEPIA OFFICINALIS JUICE9 [hp_X]/mL
SODIUM CARBONATE30 [hp_C]/mL
STRYCHNOS NUX-VOMICA SEED30 [hp_C]/mL
SUS SCROFA ADRENAL GLAND7 [hp_C]/mL
SUS SCROFA HYPOTHALAMUS7 [hp_C]/mL
SUS SCROFA PITUITARY GLAND7 [hp_C]/mL
THYROID, UNSPECIFIED7 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6P669D8HQ8, J64922108F, 1TH8Q20J0U, 00543AP1JV, 1W0775VX6E, 639KR60Q1Q, 5Q6Y7K4846, 8KFK4W7KP7, 68Y4CF58BV, QDL83WN8C2, 45P3261C7T, 269XH13919, 398IYQ16YV, N6R0856Z79, L0PFEMQ1DT, 0B4FDL9I6P

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75053-0010-1Hypothaltem118 mL in 1 BOTTLE, DROPPERLIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75053-0010HYPOTHALTEM (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]4Current NDC, Legacy NDC, 1 package rows20250322_b95050f2-f40d-4e84-8752-4d7ad75390c9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75053-0010-175053001001118 mL in 1 BOTTLE, DROPPER (75053-0010-1) 118 ml2021-05-110000-00-00NoNoCurrent