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 GARLIC; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength 3; 3; 3; 12; 12; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 44911-0580-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0580-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0580-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0580-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0580-1 1332a3947898…d4bfe170f9cd…
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 Histatone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GARLIC 3 [hp_X]/mL BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X]/mL ONION 12 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA WHOLE 12 [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 UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 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 ndc (product): 44911-0580
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