Home NDC 55714-4838 I-Waker
Product NDC 55714-4838
11-digit product format 557144838
Labeler code 55714
Product ID 55714-4838_b5a8a504-f16a-1208-e053-2995a90ae746
Type HUMAN OTC DRUG
Nonproprietary name Apis mellifica, Echinacea, Hydrastis canadensis, Thuja occidentalis, Aconitum napellus, Agaricus muscarius, Allium sativum, Aloe, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calcarea carbonica, Calendula officinalis, Capsicum annuum, Carduus marianus, Hepar sulphuris calcareum, Iodium, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Nux vomica, Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia officinalis, Selenium metallicum, Taraxacum officinale, Tarentula hispana,
Dosage form LIQUID
Route ORAL
Labeler Newton Laboratories, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2020-06-30
Marketing end 0000-00-00
Substance SELENIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA; ZINC; TOXICODENDRON PUBESCENS LEAF; ACONITUM NAPELLUS; INFLUENZA A VIRUS; APIS MELLIFERA; LYCOPODIUM CLAVATUM SPORE; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; AMANITA MUSCARIA FRUITING BODY; GARLIC; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MILK THISTLE; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; ECHINACEA, UNSPECIFIED; SAGE; INFLUENZA B VIRUS; ANEMONE PULSATILLA; AZADIRACHTA INDICA BARK; MERCURY; STRYCHNOS NUX-VOMICA SEED; GINGER; PHOSPHORUS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT
Active strength 15 [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; [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; [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; [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 2021-12-31
Current FDA listing Historical FDA.report record 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 · 2 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55714-4838 55714-4838-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55714-4838 55714-4838-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-4838 I-WAKER (APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM SATIVUM, ALOE, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALCAREA CARBONICA, CALENDULA OFFICINALIS, CAPSICUM ANNUUM, CARDUUS MARIANUS, HEPAR SULPHURIS CALCAREUM, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, SELENIUM METALLICUM, TARAXACUM OFFICINALE, TARENTULA HISPANA,) LIQUID [NEWTON LABORATORIES, INC.] 4 Legacy NDC 20250523_9aa07f0c-a2ac-2178-e053-2a95a90aa5d8.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-4838-2 55714483802 50 mL in 1 BOTTLE, GLASS (55714-4838-2) 50 ml 2020-06-30 0000-00-00 No No Current