Home NDC 44911-0515-1 Sinutone
Product NDC 44911-0515
Requested package NDC 44911-0515-1
11-digit product format 449110515
Labeler code 44911
Product ID 44911-0515_7b96bbe1-f255-4bff-aaeb-4e00b4777be4
Type HUMAN OTC DRUG
Nonproprietary name Echinacea (Angustifolia), Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata, Pulsatilla (Pratensis), Sepia, Solidago Virgaurea
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-10-09
Substance ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; NUTMEG; PULSATILLA PRATENSIS WHOLE; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength 3; 6; 12; 12; 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; [hp_X]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0515 44911-0515-1 I Inactivated by FDA excluded / ndc_excluded.zip 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 Sinutone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X]/mL GOLDENSEAL 6 [hp_X]/mL ONION 12 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA WHOLE 12 [hp_X]/mL ARSENIC TRIOXIDE 12 [hp_X]/mL POTASSIUM DICHROMATE 12 [hp_X]/mL NUTMEG 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE 12 [hp_X]/mL SEPIA OFFICINALIS JUICE 12 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 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 44911-0515-1 Sinutone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0515 SINUTONE (ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA (PRATENSIS), SEPIA, SOLIDAGO VIRGAUREA) LIQUID [ENERGIQUE, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240420_7333663c-a79d-44d2-93ac-a9254c2b32c5.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 Sinutone ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA (PRATENSIS), SEPIA, SOLIDAGO VIRGAUREA Energique, Inc. 7333663c-a79d-44d2-93ac-a9254c2b32c5 2024-04-19 Warnings Exact identifier ndc (package): 44911-0515-1 ndc (product): 44911-0515 ndc11 (package): 44911051501
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0515-1 44911051501 30 mL in 1 BOTTLE, DROPPER (44911-0515-1) 30 ml 2019-10-09 0000-00-00 No No Current