Home NDC 44911-0467 Ototone
Product NDC 44911-0467
11-digit product format 449110467
Labeler code 44911
Product ID 44911-0467_16dcd12c-ba0d-4cb5-afec-6de76a1bbfae
Type HUMAN OTC DRUG
Nonproprietary name Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Belladonna, Calcarea Carbonica, Chamomilla, Ferrum Phosphoricum, Mercurius Solubilis, Pulsatilla (Pratensis)
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-08-21
Substance BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA WHOLE; FERROSOFERRIC PHOSPHATE; MERCURIUS SOLUBILIS; PULSATILLA PRATENSIS WHOLE
Active strength 3; 3; 6; 6; 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
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 44911-0467-1 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 44911-0467-1 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 44911-0467-1 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 44911-0467-1 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 44911-0467-1 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 Ototone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X]/mL GOLDENSEAL 6 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 6 [hp_X]/mL ATROPA BELLADONNA 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL MATRICARIA CHAMOMILLA WHOLE 12 [hp_X]/mL FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL MERCURIUS SOLUBILIS 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0467-1 Ototone 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 44911-0467 OTOTONE (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)) LIQUID [ENERGIQUE, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241031_c34e0abf-02d8-4dee-a89b-3f61ab593dc3.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 Ototone BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS) Energique, Inc. c34e0abf-02d8-4dee-a89b-3f61ab593dc3 2024-10-29 Warnings Exact identifier ndc (product): 44911-0467
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0467-1 44911046701 30 mL in 1 BOTTLE, DROPPER (44911-0467-1) 30 ml 2018-08-21 0000-00-00 No No Current