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 93 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
VaselineCLINICAL CARE HAND SANITIZER LOTIONConopco Inc. d/b/a/ Unileverba0aa323-8887-597f-e053-2995a90a20772024-10-24WarningsExact identifier
unii: F5UM2KM3W7
Bowel - Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.907f582f-c060-cc60-e053-2a95a90a6f222024-10-24WarningsExact identifier
unii: C9TD27U172
unii: G0R4UBI2ZZ
Cold HPACONITUM NAPELLUS, ALLIUM CEPA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS SOLUBILIS, NUX VOMICA, PULSATILLA (VULGARIS)Energique, Inc.d13b3de8-b1bc-41bd-a964-c3d8ba9f29fd2024-10-24WarningsExact identifier
unii: U0NQ8555JD
ElimitoneBELLIS PERENNIS, ECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ARNICA MONTANA, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMEnergique, Inc.bc6352e0-6851-4971-948b-b18da7c1c8b62024-10-24WarningsExact identifier
unii: 660YQ98I10
Cort SymAPIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, MEZEREUM, RHUS TOX, ASTACUS FLUVIATILIS, GELSEMIUM SEMPERVIRENSEnergique, Inc.8e9cd014-d0fa-4e8e-bd02-5b7bf27673ff2024-10-24WarningsExact identifier
unii: WQZ3G9PF0H
Care and Comfort CreamACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALEEnergique, Inc.ac8ee81f-0af4-46d4-b63f-beeb7d120f802024-10-24WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Cognition HPANACARDIUM ORIENTALE, BELLADONNA, HYOSCYAMUS NIGER, KALI BROMATUM, VERATRUM ALBUM, BARYTA CARBONICA, LACHESIS MUTUS, PHOSPHORUS, STRAMONIUMEnergique, Inc.cd56bedf-441b-42af-ad38-def61bf810d82024-10-24WarningsExact identifier
unii: WQZ3G9PF0H
H2OCEAN NOTHINGBENZALKONIUM CL, LIDOCAINE HCLH2Ocean, LLC77896ac3-960c-41ac-8b40-053f24526fe32024-10-23WarningsExact identifier
unii: F5UM2KM3W7
Dental PainACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICADeseret Biologicals, Inc.3a117358-3c51-4870-9932-701ffe90e3f82024-10-23WarningsExact identifier
unii: W2469WNO6U
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Umcka FastActives BerryPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUSSchwabe North America, Inc149941fb-9b5f-42f2-bf0c-e5980f7daad62024-10-23WarningsExact identifier
unii: U0NQ8555JD
Blue Green FoamBENZALKONIUM CHLORIDEH2Ocean, LLC8627bf8b-2cce-45de-b37f-8478462645fa2024-10-23WarningsExact identifier
unii: F5UM2KM3W7
Trauma ReliefCHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, MILLEFOLIUM, CALENDULA OFFICINALIS, ARNICA MONTANA, BELLADONNA, BELLIS PERENNIS, CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS, SYMPHYTUM OFFICINALE, RHUS TOX, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, CARBO VEGETABILISDeseret Biologicals, Inc.651f998a-c150-4f38-8582-b9bd971409102024-10-22WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUISDeseret Biologicals, Inc.aa8f0dd4-4a3e-49ab-85cf-e4a5f48cdbf52024-10-22WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.a631a250-d6d8-479c-a53e-347ac908c5ff2024-10-22WarningsExact identifier
unii: U0NQ8555JD
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUISDeseret Biologicals, Inc.d3d8a7f4-169c-4780-852d-c96a4772e7e32024-10-22WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Immune SupportACONITUM NAPELLUS, ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, ASTRAGALUS MEMBRANACEUS, BAPTISIA TINCTORIA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2023-2024), LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SANGUINARIA CANADENSIS, SPLEEN (SUIS), SULPHUR, THUJA OCCIDENTALIS,Deseret Biologicals, Inc.076d2b43-c569-4ca4-8eb0-5a2112a6414c2024-10-22WarningsExact identifier
unii: U0NQ8555JD
Burn AideCALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, PICRICUM ACIDUM, URTICA URENSBioActive Nutritional, Inc.66f41f76-7c1f-4bd4-a6f1-cba9647c4f5c2024-10-22WarningsExact identifier
unii: WQZ3G9PF0H
RENOWN RB10 1200 ML Antibacterial Foam Hand SPBENZALKONIUM CHLORIDEHome Depot U.S.A., Inc.2501c6bc-4ee5-14ce-e063-6394a90ada212024-10-21WarningsExact identifier
unii: F5UM2KM3W7
Venoforce IICOLLINSONIA CANADENSIS, HAMAMELIS VIRGINIANA, AESCULUS HIPPOCASTANUM, BELLADONNA, CALCAREA FLUORICA, CARDUUS MARIANUS, PULSATILLA (PRATENSIS), SECALE CORNUTUM, VIPERA BERUSBioActive Nutritional, Inc.a5226861-ad3e-4352-b31c-612f7fa993dd2024-10-18WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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