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 104 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shing-VCHAMOMILLA, ECHINACEA, APIS MELLIFICA, ARSENICUM ALBUM, ASTERIAS RUBENS, CANTHARIS, CISTUS CANADENSIS, CROTON TIGLIUM, DOLICHOS PRURIENS, DULCAMARA, GRAPHITES, GRINDELIA, HYPERICUM PERFORATUM, IRIS VERSICOLO, LYCOPODIUM CLAVATUM, MEZEREUM, RANUNCULUS BULBOSUS, RHUS TOXICODENDRON, STAPHYSAGRIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMNewton Laboratories, Inc.141cc010-9b93-b82a-e063-6394a90aef442024-03-21WarningsExact identifier
unii: G0R4UBI2ZZ
Shing-VCHAMOMILLA, ECHINACEA, APIS MELLIFICA, ARSENICUM ALBUM, ASTERIAS RUBENS, CANTHARIS, CISTUS CANADENSIS, CROTON TIGLIUM, DOLICHOS PRURIENS, DULCAMARA, GRAPHITES, GRINDELIA, HYPERICUM PERFORATUM, IRIS VERSICOLO, LYCOPODIUM CLAVATUM, MEZEREUM, RANUNCULUS BULBOSUS, RHUS TOXICODENDRON, STAPHYSAGRIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMNewton Laboratories, Inc.141c2079-0766-8ca0-e063-6394a90a4bd22024-03-20WarningsExact identifier
unii: G0R4UBI2ZZ
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
unii: F5UM2KM3W7
Snore-SootheECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICANewton Laboratories, Inc.140a0bcf-82b3-c430-e063-6294a90ad38f2024-03-19WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.b742f102-a60c-4ed0-8d6c-d6721c9ec5dc2024-03-19WarningsExact identifier
unii: F5UM2KM3W7
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
unii: F5UM2KM3W7
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: G0R4UBI2ZZ
BreatheARGENTUM NITRICUM, NATRUM MURIATICUM, SULPHUR, ACONITUM NAPELLUS, ARSENICUM ALBUM, RHUS TOX, ADENOSINUM CYCLOPHOSPHORICUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, LUNG (SUIS), MUCOSA NASALIS SUIS, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, COUMARINUM, MALVIN, DYSENTERY BACILLUS, PROTEUS (MORGANI)Deseret Biologicals, Inc8dbdd623-a486-4cf8-acdb-ad051dc743482024-03-15WarningsExact identifier
unii: U0NQ8555JD
EcoCare 360BENZALKONIUMEcolab Inc.9f4571f3-7dbc-46ea-8a26-a0262469e67c2024-03-13WarningsExact identifier
unii: F5UM2KM3W7
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEKesin Pharma Corporation25c2b417-eeea-4ba6-8eb9-a7d8a08c60932024-03-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lymph FormulaASTRAGALUS MEMBRANACEUS, ANGELICA SINENSIS, MYRRHA, ACONITUM NAPELLUS, EPHEDRA VULGARISNutritional Specialties, Inc.b0bb0b3c-9d88-41a0-aeb6-b969c5702c3a2024-03-11WarningsExact identifier
unii: U0NQ8555JD
Lymph FormulaASTRAGALUS MEMBRANACEUS, ANGELICA SINENSIS, MYRRHA, ACONITUM NAPELLUS, CONIUM MACULATUMNutritional Specialties, Inc.1abfdcce-6b8a-4079-80d9-f9ce9be70b492024-03-11WarningsExact identifier
unii: U0NQ8555JD
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUMDeseret Biologicals, Inc.81f29472-a2e6-486d-aefd-17135ad410ef2024-03-08WarningsExact identifier
unii: G0R4UBI2ZZ
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Trauma RemedyCHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, MILLEFOLIUM, CALENDULA OFFICINALIS, ARNICA MONTANA, BELLIS PERENNIS, RHUS TOX, BRYONIA (ALBA), CLEMATIS VITALBA, FOLIA, HEPAR SULPHURIS CALCAREUM, ORNITHOGALUM UMBELLATUM, PRUNUS CERASIFERA, FLOS, CARBO VEGETABILISDeseret Biologicals, Inc.d8610c75-2d98-4810-8265-96f8f151b61f2024-03-07WarningsExact identifier
unii: G0R4UBI2ZZ
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
unii: F5UM2KM3W7
PyostatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ANTHRACINUM, ARSENICUM ALBUM, BELLADONNA, CROTALUS HORRIDUS, HYOSCYAMUS NIGER, LACHESIS MUTUS, PYROGENIUM, TARENTULA CUBENSISEnergique, Inc.4462bb04-6b57-4510-9b2a-2cc5bc5a45cf2024-03-05WarningsExact identifier
unii: WQZ3G9PF0H
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2022-2023), MORBILLINUMDeseret Biologicals, Inc.ce3962de-576a-49f6-8dc3-68ba7ad96e9f2024-03-05WarningsExact identifier
unii: U0NQ8555JD
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: 660YQ98I10
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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