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 95 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
McKesson Obstetrical Antiseptic ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgical51a3dabe-25d3-47fd-b640-83e68f7e06de2024-10-11WarningsExact identifier
unii: F5UM2KM3W7
McKesson Benzalkonium Chloride ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgicalcea36a9e-aac3-4494-a713-1dc64272d99c2024-10-11WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 377 FreeBENZALKONIUM CHLORIDEWhisk Products, Inc.20c31cf2-7d01-ce84-e063-6294a90a1c3d2024-10-07WarningsExact identifier
unii: F5UM2KM3W7
Hydration ComplexBOLDO, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, HYPERICUM PERFORATUM, GINKGO BILOBA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, GERMANIUM SESQUIOXIDE, SILICEA, CALCAREA FLUORICA, CALCAREA PHOSPHORICADeseret Biologicals, Inc.891265ff-2651-4d84-a77b-331e3eb7e3ec2024-10-04WarningsExact identifier
unii: 660YQ98I10
BART PLUSARNICA MONTANA, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, LEDUM PALUSTRE, THYROIDINUM (SUIS), ARBUTUS ANDRACHNE, APIS MELLIFICA, ARSENICUM ALBUM, COCCULUS INDICUS, GUNPOWDER, HEPAR SULPHURIS CALCAREUM, KALMIA LATIFOLIA, LAC CANINUM, LYCOPODIUM CLAVATUM, VERATRUM ALBUM, ACONITUM NAPELLUS, STRAMONIUM, TELLURIUM METALLICUMDeseret Biologicals, Inc.ffdaf5a6-6174-425e-81e1-8c8149b9e5472024-10-04WarningsExact identifier
unii: U0NQ8555JD
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack473369cb-3a9b-437c-b08e-8fb38034c5072024-10-03Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
DiaSincBENZALKONIUM CHLORIDEPureTek Corporationd9ba1ca8-8883-11bb-e053-2995a90a58462024-10-02WarningsExact identifier
unii: F5UM2KM3W7
GenRx Hand SanitizingBENZALKONIUM CHLORIDEPureTek Corporationa12715c0-77f2-7716-e053-2995a90a06d32024-10-02WarningsExact identifier
unii: F5UM2KM3W7
Wet Ones Antibacterial Non Plastic Hand WipesBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLCe9abef25-773e-b67f-e053-2995a90a36402024-10-01WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPf191b15c-7959-4aa6-a2ef-617cde77c9182024-10-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDESomerset Therapeutics, LLC32809eae-1c3f-96fc-e063-6394a90aeaad2024-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, RHUS TOX, PYROGENIUM, INFLUENZINUMEnergique, Inc.d22d399e-d2e3-4833-b59a-d841022cc02f2024-09-30WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Pest and Dustmite FormulaAMYL NITROSUM, EUPHRASIA OFFICINALIS, KALI MURIATICUM, WYETHIA HELENOIDES, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, GLANDULA SUPRARENALIS SUIS, MUCOSA NASALIS SUIS, ALLIUM CEPA, ARSENICUM ALBUM, BLATTA AMERICANA, IRIDIUM METALLICUM, SABADILLA, SELENIUM METALLICUM, LAC FELINUM, HYALURONIDASE, INTERFERON (SUIS), SEROTONIN (HYDROCHLORIDE), HOUSE DUST MITEDeseret Biologicals, Inc.b1d685d3-a51e-4070-957d-efce7cf916552024-09-27WarningsExact identifier
unii: 660YQ98I10
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
unii: F5UM2KM3W7
Flu HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENSEnergique, Inc.293a47b3-10b4-4f01-8549-9071014e28032024-09-24WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
TobaccoCHAMOMILLA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ALLIUM SATIVUM, ARGENTUM NITRICUM, AVENA SATIVA, CALADIUM SEGUINUM, KALI BICHROMICUM, LOBELIA INFLATA, LYCOPODIUM CLAVATUM, SEROTONIN (HYDROCHLORIDE), TABACUM, ADRENALINUM, AMMONIACUM GUMMI, BALSAMUM PERUVIANUM, CACTUS CACTI, SELENIUM METALLICUMDeseret Biologicals, Inc.68d6780a-e247-48d9-9a54-4b7c6a3e68162024-09-23WarningsExact identifier
unii: G0R4UBI2ZZ
LymphaparECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEAEnergique, Inc.c746c111-7ebc-46c1-b11b-04271887df9c2024-09-23WarningsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBryant Ranch Prepackb5505a39-57f1-4ed5-b845-4f1d8aa109502024-09-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dial antibacterial and sensitive hypoallergenic barBENZALKONIUM CHLORIDEHenkel Corporation2269bac8-b724-feb8-e063-6394a90a52ff2024-09-18WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack8bae6f0f-58ca-490f-a725-8ec4bc6ba5142024-09-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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