Home NDC 44911-0580 Histatone
Product NDC 44911-0580
11-digit product format 449110580
Labeler code 44911
Product ID 44911-0580_d701f94c-3c2d-421e-89ed-58237b458e95
Type HUMAN OTC DRUG
Nonproprietary name Allium Sativum, Baptisia Tinctoria, Echinacea (Angustifolia), Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Phosphorus, Pulsatilla (Pratensis), Solidago Virgaurea
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-05-25
Substance AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; GARLIC; ONION; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength 12; 12; 3; 3; 3; 12; 12; 12; 12 [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_X]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Histatone ALLIUM SATIVUM, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREA Energique, Inc. 309fe946-8639-4c17-a939-06bffe6caa2d 2024-10-25 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Additional Listing Data#
Finished product Yes
Brand name base Histatone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GARLIC 12 [hp_X]/mL BAPTISIA TINCTORIA ROOT 12 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X]/mL ONION 3 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA WHOLE 3 [hp_X]/mL ARSENIC TRIOXIDE 12 [hp_X]/mL PHOSPHORUS 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE 12 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X]/mL
Harmonized Identifiers# Field, Values table Field Values Unii V1V998DC17, 5EF0HWI5WU, VB06AV5US8, 492225Q21H, 9W34L2CQ9A, S7V92P67HO, 27YLU75U4W, 8E272251DI, 5405K23S50
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0580-1 Histatone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0580 HISTATONE (ALLIUM SATIVUM, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREA) LIQUID [ENERGIQUE, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241027_309fe946-8639-4c17-a939-06bffe6caa2d.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0580-1 44911058001 30 mL in 1 BOTTLE, DROPPER (44911-0580-1) 30 ml 2021-05-25 0000-00-00 No No Current