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 55 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Lift Antibacterial Body WashBENZALKONIUM CHLORIDESpa de Soleilab9dde33-1bd2-062f-e053-2a95a90a4d182025-10-10WarningsExact identifier
unii: F5UM2KM3W7
Dr Lift AntibacterialBENZALKONIUM CHLORIDESpa de Soleilaf89675e-e66f-0922-e053-2995a90ab9d22025-10-10WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limitedf4e36462-3522-4130-8785-6c18871d29842025-10-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ANTISEPTIC WIPE 01BENZALKONIUM CHLORIDETotal Resources International Inc.cf4a6a97-529e-7f11-e053-2a95a90a75a92025-10-10WarningsExact identifier
unii: F5UM2KM3W7
Fibromyalgia SupportACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company36892361-994e-4a6d-972a-9ea9b72f89fe2025-10-09WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
KleenLine Essentials Alcohol Free Foaming Hand SanitizerALCOHOL FREE FOAMING HAND SANITIZERBrady Industries3fb3a4f3-e018-f681-e063-6394a90a9cdc2025-10-08WarningsExact identifier
unii: F5UM2KM3W7
MediChoice BZK AntisepticBENZALKONIUM CHLORIDEO&M HALYARD, INC.82a7710d-a9fa-4f68-8322-046a765ae9292025-10-08WarningsExact identifier
unii: F5UM2KM3W7
MediChoice CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.79d41cf0-301f-44d4-a76c-f4850c7ddce92025-10-08WarningsExact identifier
unii: F5UM2KM3W7
Wipe Those HandsBENZALKONIUM CHLORIDEMighty Good Solutions, LLC45b217ee-1524-4508-a18f-7db6a30d51692025-10-07WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCfbed8c29-b3f1-4e53-b290-6f717290cecf2025-10-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aconitum napellusACONITEHistorical Remediesc67753ee-08d9-a2fc-e053-2995a90aab992025-10-07WarningsExact identifier
unii: U0NQ8555JD
BelladonnaBELLADONNAHistorical Remediesc6784560-5d61-78b3-e053-2995a90adc252025-10-07WarningsExact identifier
unii: WQZ3G9PF0H
Homeopathic Pick Up DropsGELSEMIUM SEMPERVIRENS ROOT 12X, MATRICARIA CHAMOMILLA12X, ARNICA MONTANA WHOLE 12X,, PHOSPHORIC ACID 12X, ANEMONE PULSATILLA 12X, ACONITUM NAPELLUS 12X, STRYCHNOS NUX-VOMICA SEED 12XHISTORICAL REMEDIES LLP.0dfcc558-614d-4552-b45d-01402edcc4e92025-10-07WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: G0R4UBI2ZZ
Homeopathic Stress MintsAGRIMONIA EUPATORIA 3X, MATRICARIA CHAMOMILLA 12X, ARNICA MONTANA 12X, PHOSPHORIC ACID 12X, AVENA SATIVA FLOWERING TOP 3X, STRYCHNOS IGNATII SEED 12X, ANEMONE PULSATILLA 12X, ACONITUM NAPELLUS 12X, STRYCHNOS NUX VOMICA SEED 12XHistorical Remedies LLP828d0f4d-915e-4340-bb98-62cd17eb970b2025-10-07WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
FoamyIQ Eucalyptus Mint Sanitizing HandwashBENZALKONIUM CHLORIDESpartan Chemical Company, Inc.6c78d527-cbca-429a-9ce3-13c392de707e2025-10-07WarningsExact identifier
unii: F5UM2KM3W7
Lite nFoamy Eucalyptus Mint Sanitizing HandwashBENZALKONIUM CHLORIDESpartan Chemical Company, Inc.b464daa7-354a-4a6d-97aa-f77911aa5dc32025-10-07WarningsExact identifier
unii: F5UM2KM3W7
FoamyIQ E2 Sanitizing HandwashBENZALKONIUM CHLORIDESpartan Chemical Company, Inc.40d4721a-3b69-4a6d-a032-e15141109ede2025-10-07WarningsExact identifier
unii: F5UM2KM3W7
Lite nFoamy E2 Sanitizing HandwashBENZALKONIUM CHLORIDESpartan Chemical Company, Inc.eb72b3ba-9cdd-40af-8e02-aa4b78ee02cc2025-10-07WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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