I-Waker

Product NDC
55714-4838
Requested package NDC
55714-4838-2
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55714-483855714-4838-2DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4838I-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.]4Legacy NDC20250523_9aa07f0c-a2ac-2178-e053-2a95a90aa5d8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4838-25571448380250 mL in 1 BOTTLE, GLASS (55714-4838-2) 50 ml2020-06-300000-00-00NoNoCurrent