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 62 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedPride Bath WipesBENZALKONIUM CHLORIDEShield Line LLCecf7e545-21ca-bbe0-e053-2995a90a9a552025-08-15WarningsExact identifier
unii: F5UM2KM3W7
Natures Way Cold Flu Relief Fastactives Berry FlavoredPELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS WHOLE, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM TOP, SEMPERVIRENS ROOT, PHOSPHORUS, IPECACUniversal Synergetics, Inc444081b1-c78f-4474-a084-e7bd2cc2eb3f2025-08-14WarningsExact identifier
unii: U0NQ8555JD
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: 660YQ98I10
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: 660YQ98I10
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEHAIAN KANGRUI TEXTILE CO., LTD.3c273544-4562-8f37-e063-6394a90ab4d32025-08-12WarningsExact identifier
unii: F5UM2KM3W7
HealthWise Lidocaine CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEVeridian Healthcare6022803a-097e-41c6-b9ee-48c8ef380d7a2025-08-12WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeBENZALKONIUM CHLORIDEQuest USA Corp17b907cf-ae7d-49bd-9624-cd708dbb011e2025-08-12WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.bf8e8ac7-e6a8-4571-a0ea-7bcab89290f62025-08-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAvKARE3bdfced1-6e62-9e92-e063-6294a90a28aa2025-08-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3be29fcc-765e-8653-e063-6394a90a59d52025-08-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDESlate Run Pharmaceuticals, LLC94ae03cc-b620-0dbb-e053-2a95a90a922c2025-08-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDESlate Run Pharmaceuticals, LLC0cc57ece-f15a-4160-a5ea-8d6fa9f9e7542025-08-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC0e2b4917-0422-b320-e063-6394a90a731b2025-08-07WarningsExact identifier
unii: F5UM2KM3W7
Armor Antibacterial Body Treatment Benzalkonium ChlorideBENZALKONIUM CHLORIDERida LLC95761213-bf90-4ba6-a17b-7470a0f316232025-08-05WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.47a87fb6-5e61-41c9-b759-10f7c74a67ce2025-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health Packaging7956883f-0d31-4081-bbea-d9ea320a193b2025-08-04Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
AerowipeANSTISEPTIC WIPEAero Healthcare34ca12c7-9281-263c-e054-00144ff8d46c2025-08-01WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONMarlex Pharmaceuticals Inc3e78028d-21a0-ba0f-e063-6294a90aac492025-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONMarlex Pharmaceuticals, Inc.3e8a6f61-44eb-4b5a-e063-6294a90a4b1b2025-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Cold Flu Relief BerryCOLD FLU RELIEF BERRYSchwabe North America, Inc13e5c2a9-747d-4c01-89bd-47b6e8d453f72025-07-31WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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