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 116 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium chloridePOTASSIUM CHLORIDEANI Pharmaceuticals, Inc.0128a879-7185-4b70-b0bb-d108ff1c95422023-07-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Melatonin ProCALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)Energique, Inc.1f374642-83f7-4e64-b330-0f6ef21000a92023-07-19WarningsExact identifier
unii: G0R4UBI2ZZ
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals0cf8a815-808d-4018-baf9-2b4545fc7ea82023-07-19WarningsExact identifier
unii: U0NQ8555JD
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: W2469WNO6U
unii: G0R4UBI2ZZ
BelladonnaATROPA BELLADONNABoiron8476e7fa-a0b5-f06b-e053-2991aa0a73312023-07-11Exact identifier
unii: WQZ3G9PF0H
MetexPLANTAGO MAJOR, LYCOPODIUM CLAVATUM, ARSENICUM ALBUM, CADMIUM METALLICUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, MERCURIUS VIVUS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, ZINCUM METALLICUMNutritional Specialties, Inc.4e41d9f5-380a-42b8-8a11-56cf2df301182023-07-11WarningsExact identifier
unii: W2469WNO6U
Facial Pain FormulaSALIX NIGRA, BELLADONNA, CEREBELLUM (SUIS), ACONITUM NAPELLUSNutritional Specialties, Inc.e9281311-8ba8-4a5a-91a2-8a6bec0da0ad2023-07-06WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Hypercalm-Mental FocusCHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDENewton Laboratories, Inc.ff5f22e1-74ee-1eee-e053-6394a90a26782023-06-30WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Hypercalm-Mental FocusCHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDENewton Laboratories, Inc.ff604442-4697-e2bb-e053-6394a90a03402023-06-30WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Flu FormulaAPIS MELLIFICA, ACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, IPECACUANHA, BELLADONNA, ECHINACEA PURPUREA, ASCLEPIAS VINCETOXICUM, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, INFLUENZINUMNutritional Specialties, Inc.811d21d9-d7b7-44d5-885b-7bfb49cd069b2023-06-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fecece1f-22bc-21dc-e053-6294a90ad0c32023-06-23WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fed03a1c-0ea8-1f8e-e053-6394a90a04c02023-06-23WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Spineforce S-HPACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, COLCHICUM AUTUMNALE, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PLUMBUM METALLICUM, RHUS TOX, ARNICA MONTANABioActive Nutritional, Inc.0ca4f64f-3c28-488b-bb48-ce8ab67951c82023-06-14WarningsExact identifier
unii: U0NQ8555JD
Potassium ChloridePOTASSIUM CHLORIDENexus Pharamaceuticals Inc.765ef38c-df36-46d1-9062-61e30ff46a862023-06-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ACONITEACONITUM NAPELLUSENERGIQUE, INC.e5f8aa8c-0764-49e8-a2b1-4b8291eef8822023-06-07WarningsExact identifier
unii: U0NQ8555JD
CalciforceARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICABioActive Nutritional, Inc.1609ce3e-82c2-4597-86e6-847c944ddbe62023-06-07WarningsExact identifier
unii: G0R4UBI2ZZ
Anxiety II HPACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARCINOSIN, CAUSTICUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, MERCURIUS VIVUS, NITRICUM ACIDUM, PHOSPHORUS, RHUS TOXBioActive Nutritional, Inc.c4f51f32-beb3-410a-9ff3-f5c27bbb37c32023-06-06WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
ReboostACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GOLDENSEAL, LACHESIS MUTA VENOM, PHOSPHORUS, VINCETOXICUM HIRUNDINARIA ROOT, ZINC GLUCONATE, ZINC ACETATE ANHYDROUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, IPECAC, SULFURMediNatura Inc.781c1a63-5210-4069-8427-bc7df68d6d632023-06-05WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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