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 29 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Covex Antibacterial Bar Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIaa5cf2af-0061-c04c-e053-2a95a90aeb972026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizer WipesJUNIPER CLEANKYNC Design LLCa73134a6-8b71-fb0d-e053-2995a90abc062026-01-23WarningsExact identifier
unii: F5UM2KM3W7
CaseysLavenderCASEYS HAND SOAP LAVENDER SCENTKYNC Design LLCb5bc8770-13ef-36dc-e053-2995a90a3f512026-01-23WarningsExact identifier
unii: F5UM2KM3W7
JuniperClean LavenderJUNIPER CLEAN HAND SOAP LAVENDERKYNC Design LLC0bf0000f-5c91-8731-e063-6294a90a52df2026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Everlit Survival Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3a03f7e6-cc74-22a2-e063-6394a90a5f9f2026-01-23WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS Sanitizing BODYBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incb9828d1e-e6e2-4d02-bfc6-7fd37c0836412026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1e927-3b65-372e-e053-2a95a90accdc2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1fcab-9d55-4272-e053-2995a90a3bd02026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1bbb2-18a3-2b00-e053-2995a90ace3c2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18ed1f-1428-49c9-e053-2a95a90ac4c82026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae1-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae5-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e0-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19269c-cd28-f12f-e053-2a95a90ab0162026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Liquid Hand Wash Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e2-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
POKONZA potassium chloridePOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC2d938cbf-27aa-4f9c-a582-5564d3b724652026-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
unii: F5UM2KM3W7
LIGHTS SwabstickBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.9346512e-53a1-420a-8b4d-bfbec32576a22026-01-21WarningsExact identifier
unii: F5UM2KM3W7
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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