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 23 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand WashBENZALKONIUM CHLORIDEOld East Main Co.29e5da06-8897-4a79-8eea-f359ba0bdf782026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDEOld East Main Co.3effae93-fd00-4aac-a42f-b5b67123f8512026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Old East Main Co.122154ea-bdb3-4e71-bfd5-f1f28d75fb2e2026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Restless LegsARSENICUM ALBUM, CAUSTICUM, CHAMOMILLA, LYCOPODIUM CLAVATUM, PALLADIUM METALLICUM, PLATINUM METALLICUM, ZINCUM METALLICUMNaturalCare1e245ee1-b76f-49ed-9403-9d91d0492ab92026-03-02WarningsExact identifier
unii: G0R4UBI2ZZ
First Aid mind and BodyACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, RHUS TOX, SULPHUR, SYMPHYTUM, TRIFOLIUM PRATENSE, AND VERATRUM ALBUM.King Bio Inc.20d4a0a3-7e69-4956-aaff-21703e2bb0302026-03-02WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Peace and QuietCHAMOMILLA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, MAGNESIUM MURIATICA, PASSIFLORA INCARNATANaturalCare412b02bf-1382-418d-bd75-b7bf344dcd4e2026-03-02WarningsExact identifier
unii: G0R4UBI2ZZ
InfluensegGELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, GALPHIMIA GLAUCA, CAUSTICUM, EUPATORIUM PERFOLIATUM, IPECACUANHA, ACONITUM NAPELLUS, KALI BICHROMICUM, AVENA SATIVA, INFLUENZINUM (2024-2025), LOBELIA PURPURESCENS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ECHINACEA (ANGUSTIFOLIA), CANCHALAGUANucleic Products, LLC6d673ec9-fdb3-48a0-9a4f-bb65e290f9a42026-02-27WarningsExact identifier
unii: U0NQ8555JD
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%The Kroger Co.c13d327a-5bb2-43fa-bc0b-9199e7fd3a382026-02-27Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
MedPride SterileBENZALKONIUM CHLORIDEShield Line LLC02f63d50-e4ff-49b6-9f8c-fddceefe65f32026-02-27WarningsExact identifier
unii: F5UM2KM3W7
Rhus AconitumRHUS ACONITUMUriel Pharmacy Inc.a176c241-fc2d-4fea-82d9-81183971b4cf2026-02-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Chrysosplenium ChamomillaCHRYSOSPLENIUM CHAMOMILLAUriel Pharmacy Inc.d2c9746c-784b-4d76-874b-4f8ea6814f992026-02-27WarningsExact identifier
unii: G0R4UBI2ZZ
Moisturizing AntibacterialBENZALKONIUM CHLORIDEWalmart Inc.f80ea170-bbb6-47a8-af70-d489af7f3ddc2026-02-27Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDEWalmart Inc.0001d1cf-f727-4875-a44f-5a51f7b617a42026-02-27WarningsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDEWalmart Inc.0beb635e-9f5a-4d80-ad5d-5b92a47c85dc2026-02-27WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEWalmart Inc.99fba457-0eea-4c0b-987f-6a1690f503fb2026-02-27Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
911 Stress and AnxiousnessACONITUM NAPELLUS, ALFALFA, APIS MELLIFICA, AVENA SATIVA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS VITALBA, FLOS, HISTAMINUM HYDROCHLORICUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHORICUM, LILIUM TIGRINUM, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, PULSATILLA, AND VALERIANA OFFICINALIS.King Bio Inc.135d20b1-c87a-489b-b105-352b6048546a2026-02-27WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltd.e5cb1df5-1e13-4a0b-939e-071c577bcf152026-02-26WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Inc485bf58b-bd97-d068-e063-6394a90ab3e72026-02-24Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Inc485b4296-bb2a-ceac-e063-6394a90a5bba2026-02-24Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Outdoor AllergiesACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLENNaturalCareb0a76faa-a081-4cee-ae40-e5605458bec32026-02-23WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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