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 49 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cleansing WipesCLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD43d6041f-18d1-b0e3-e063-6294a90a7c792025-11-17WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial Calm and SootheBENZALKONIUM CHLORIDEHenkel Corporatione81a2af6-fb4c-702d-e053-2995a90a6eaf2025-11-14WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial BarDIAL MOUNTAIN FRESH ANTIBACTERIAL BAR SOAPHenkel Corporation568518c8-e327-45a7-e054-00144ff8d46c2025-11-14WarningsExact identifier
unii: F5UM2KM3W7
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
unii: F5UM2KM3W7
PM Toothache ReliefBENZOCAINECVS0a5a8cd0-d680-8a0f-e063-6294a90aa65c2025-11-14WarningsExact identifier
unii: F5UM2KM3W7
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
unii: F5UM2KM3W7
4x Medicated Toothache and Gum CreamBENZOCAINEWalgreensa71c2092-4ece-b82e-e053-2995a90ac9332025-11-14WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial BarDIAL GOLD ANTIBACTERIAL BAR SOAPHenkel Corporation9e52beca-e8f2-3fa8-e053-2995a90aedd72025-11-13WarningsExact identifier
unii: F5UM2KM3W7
4x Medicated Toothache and Gum GelBENZOCAINEWalgreensa71c47de-d35d-49da-e053-2995a90a823c2025-11-13WarningsExact identifier
unii: F5UM2KM3W7
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
unii: F5UM2KM3W7
4X Medicated Toothache and Gum GelBENZOCAINEWalmarta471a858-edbf-c31e-e053-2995a90a71562025-11-13WarningsExact identifier
unii: F5UM2KM3W7
4X Medicated Severe Toothache and Gum CreamBENZOCAINERite Aid996fdbeb-1fe3-77b6-e053-2995a90a25c72025-11-13WarningsExact identifier
unii: F5UM2KM3W7
Topco 4x Medicated Toothache and Gum GelBENZOCAINETopCareb463ea94-08a9-ca5d-e053-2a95a90a224b2025-11-13WarningsExact identifier
unii: F5UM2KM3W7
4X Medicated Severe Toothache and Gum GelBENZOCAINERite Aid99703bf4-f169-5e05-e053-2995a90afab42025-11-13WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial BarDIAL WHITE ANTIBACTERIAL BAR SOAPHenkel Corporation5691b718-bb66-1529-e054-00144ff88e882025-11-13WarningsExact identifier
unii: F5UM2KM3W7
Dial Complete Antibacterial Bar Spring WaterBENZALKONIUM CHLORIDEHenkel Corporationbd0db24a-668c-b9d0-e053-2a95a90aafbb2025-11-13WarningsExact identifier
unii: F5UM2KM3W7
BURN RELIEFARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUMNatrural Creations, Inc.79c80c6c-1fd9-4b32-81e0-ff6a1f6102272025-11-13WarningsExact identifier
unii: WQZ3G9PF0H
BACK HPACONITUM NAPELLUS, HORSE CHESTNUT, COLCHICUM AUTUMNALE BULB, HYPERICUM PERFORATUM, MAGNESIUM PHOSPHATE DIBASIC TRIHYDRATE, LEAD, TOXICODENDRON PUBESCENS LEAF, ARNICA MONTANANatural Creations, Inc.e589c7a2-0a7b-44ca-835d-ff25c66061522025-11-13WarningsExact identifier
unii: U0NQ8555JD
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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