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 102 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.04dfad30-9496-43c6-8ce8-ab04fdb9ce3b2024-05-06WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Tork Hand Sanitizer Alcohol Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCd2e6d469-ddcc-4cad-829f-245dc1ec83682024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Tork Foam AntibacterialBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC45416b88-3703-4934-9439-9f23233427442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe0bded7-a268-db59-e053-6294a90aee442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP enMotion Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsc846eb52-3db4-1a74-e053-2a95a90aa84d2024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Pacific Blue ultra Antimicrobial Foam Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe165a79-6947-eb25-e053-6294a90a98f52024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP PBU Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia Pacific Consumer Productsc8d09207-d152-5abc-e053-2a95a90aaf922024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfdb5776b-7d6c-84f9-e053-6394a90a0c392024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Pacific Blue ultra Antimicrobial Foam Pacific CitrusBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe1727b4-b016-74fc-e053-6394a90ad78a2024-05-02WarningsExact identifier
unii: F5UM2KM3W7
CliniClean BZK Cleansing SwabsticksBENZALKONIUM CHLORIDEHR HealthCaree4978038-58ee-4ca3-b05f-d5ecab102fa92024-04-30WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCc2467d57-cd2d-4409-bcc0-50128bd01bba2024-04-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ProClean Foam Nexa Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.1c607f52-64c0-4a86-8fa4-e988dec5fe4b2024-04-26WarningsExact identifier
unii: F5UM2KM3W7
Reliance Hand SaniziterBENZALKONIUM CHLORIDEEcolab Inc.ee843339-064a-4aa9-84d0-a232f8d3f0b02024-04-26WarningsExact identifier
unii: F5UM2KM3W7
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
unii: F5UM2KM3W7
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
unii: F5UM2KM3W7
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C9TD27U172
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Stomachforce ATRITICUM AESTIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, FRAGARIA VESCA, HAMAMELIS VIRGINIANA, QUASSIA (AMARA), SENNA CASSIA ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PODOPHYLLUM PELTATUM, HEPAR BOVINE, PANCREAS SUIS, SPLEEN (BOVINE), BELLADONNA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, GIARDIA LAMBLIA, ENTAMOEBA HISTOLYTICABioActive Nutritional, Inc.1e4bccd6-11ed-42ca-8072-98996e1421c32024-04-19WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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