FDA.reportPublic FDA data

NDC 64616-045-01 - Earache Remedy

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64616-045
Requested NDC
64616-045-01
Package NDCs from labels
64616-045-01, 64616-045-02
Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ear Drops - Vitality Works, Inc.Vitality Works, Inc.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-045-01Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID1510
64616-045-02Earache Remedy1 in 1 CARTONLIQUID110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-045EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]9Current NDC, Legacy NDC, 2 package rows20241212_49afb2c3-ee42-4be9-943a-36d73ded0004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2

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 77 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: W2469WNO6U
D-80BAPTISIA TINCTORIA ROOT, LACHESIS MUTA VENOM, ECHINACEA ANGUSTIFOLIA, BRYONIA ALBA ROOT, ACONITUM NAPELLUS, SOLIDAGO VIRGAUREA FLOWERING TOP, AND AVENA SATIVA FLOWERING TOPDNA Labs, Inc.83e4ab65-514d-47ab-9d99-147168587ab22025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-54DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICEDNA Labs, Inc.68a206a8-6f66-4957-843c-4c4c0636e78f2025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-62ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, FERROSOFERRIC PHOSPHATE, MERCURIUS SOLUBILIS, AND ANEMONE PRATENSISDNA Labs, Inc.1e70833f-5fcb-4e04-af34-ebe35d70321e2025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-55COMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.1a316983-a023-4174-9aef-9e268a5799c12025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-35ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, AND BRYONIA ALBA ROOTDNA Labs, Inc.275cc8ec-30ed-4dd9-815c-d082ee5b3a992025-01-13WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: W2469WNO6U
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-96CATNIP, MATRICARIA CHAMOMILLA, GINGER, AND MENTHA PIPERITADNA Labs, Inc.88a53b92-fd44-40b6-ae8f-5b318757f6d02025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-125POTASSIUM CHLORIDEDNA Labs, Inc.71b92f48-edee-49a4-a87f-7b284e1b45a02025-01-13WarningsExact identifier
unii: 660YQ98I10
D-71ACONITUM NAPELLUS, ARSENIC TRIOXIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.478668a3-bf20-4205-a81a-2f9e4565f8762025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-75CAULOPHYLLUM THALICTROIDES ROOT, MATRICARIA CHAMOMILLA, BLACK COHOSH, CUPRIC ACETATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND VIBURNUM OPULUS BARKDNA Labs, Inc.28558d59-8e55-4a72-8d42-de3f54d4ebbb2025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: W2469WNO6U
unii: U0NQ8555JD
D-117ATROPA BELLADONNA AND SILICON DIOXIDEDNA Labs, Inc.8bcce284-f8f3-4d62-a13e-b93c2c655a702025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-119PLANTAGO MAJOR, DELPHINIUM STAPHISAGRIA SEED, MATRICARIA CHAMOMILLA, SEPIA OFFICINALIS JUICE, ARNICA MONTANA, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, SPIGELIA ANTHELMIA, IRON, BARIUM CARBONATE, VERATRUM ALBUM ROOT, CALCIUM FLUORIDE, ANTIPYRINE, AND BISMUTH SUBNITRATEDNA Labs, Inc.c9463aa1-ac37-42f9-bc2b-785e3d2befad2025-01-13WarningsExact identifier
unii: W2469WNO6U
unii: G0R4UBI2ZZ
D-91APIS MELLIFERA AND ATROPA BELLADONNADNA Labs, Inc.dac07ef4-d76c-47c1-a29a-e76a1fa78ea82025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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