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 123 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold - CoughINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.98e7a385-aa56-f5fe-e053-2995a90a84d32022-03-17WarningsExact identifier
unii: C9TD27U172
Cold - SinusINFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEANewton Laboratories, Inc.7a40e3b3-baa7-3ce8-e053-2991aa0a4d072022-03-17WarningsExact identifier
unii: C9TD27U172
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da717cf0-54af-c4e2-e053-2995a90ac97c2022-03-17WarningsExact identifier
unii: C9TD27U172
unii: W2469WNO6U
unii: WQZ3G9PF0H
VIRAL HPARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAFZorex International1e1bed7c-4af9-4276-85a3-57ebe1d19d4b2022-03-03WarningsExact identifier
unii: WQZ3G9PF0H
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEB. Braun Medical Inc.ab67b151-8368-4321-b562-bad5eff7b7402022-02-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aconitum Napellus 200CACONITUM NAPELLUSNatural Creations, Inc91f429ad-10ef-45e0-b7f8-3c254d873cb52022-02-14WarningsExact identifier
unii: U0NQ8555JD
INFL CombinationEUCALYPTUS GLOBULUS, IPECACUANHA, ACONITUM NAPELLUS, ADENOVIREN NOSODE, INFLUENZINUM 2020-2021, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KREOSOTUM, VERATRUM VIRIDEDeseret Biologicals, Inc.d65c70ec-acfe-4a1a-bd3c-5bd97ad0116c2022-02-02WarningsExact identifier
unii: U0NQ8555JD
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDETris Pharma Inc159ddd0b-847e-4ecc-b3b2-9634cbb4dfa92022-01-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Good Night SleepACONITUM NAP, AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAGRIA, VALERIANASilver Star Brandsd66d4ba2-8917-ae07-e053-2995a90abbd02022-01-25WarningsExact identifier
unii: U0NQ8555JD
HydrAphexHYDRAPHEXAphex Biocleanse Systems, Inca6035c7d-0f5b-3295-e053-2995a90af89c2022-01-17WarningsExact identifier
unii: F5UM2KM3W7
Schusslers ImmuneECHINACEA, FERRUM PHOSPHORICUM, KALI MURIATICUM, ZINCUM GLUCONICUMNartex Laboratorios Homeopaticos, S.A. de C.V.d46a3ac3-a37a-743d-e053-2a95a90ab0b12022-01-13WarningsExact identifier
unii: 660YQ98I10
ChamomillaCHAMOMILLAOHM PHARMA INC.eddff8d8-ec79-4d09-addf-bedb6c1847aa2021-12-30WarningsExact identifier
unii: G0R4UBI2ZZ
FLU TERMINATOR DROPSGELSEMIUM, ZINCUM GLUCONICUM, ZINCUM METALLICUM, ACONITUM NAPELLUS, EUPATORIUM PERFOLIATUM, SULPHUR, PHOSPHORUS, ASCLEPIAS VINCETOXICUM, INFLUENZINUM, ANAS BARBARIAE.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathicsc818b723-e038-47b0-940a-f2bb7edfd69c2021-12-29WarningsExact identifier
unii: U0NQ8555JD
Arnica Plus DROPSACONITUM NAPELLUS, ARNICA MONTANA, CHAMOMILLA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, BELLADONNA, COLOCYNTHIS, RHUS TOX, FERRUM PHOS, MAGNESIUM PHOS.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics54402c83-02bd-434e-a27e-b55b3fedcfc52021-12-29WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Lung DropsBELLADONNA, IPECACUANHA, LOBELIA INFLATA, QUEBRACHO, ANTIMONIUM TARTARICUM, BLATTA ORIENTALIS, NAPHTHALINUM, NATRUM SULPHURICUM, PULSATILLA, RUMEX CRISPUS, MERCURIUS SOLUBILIS, ADRENALINUM.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics684459e3-d6ae-4f7f-b823-539cbb9445c12021-12-29WarningsExact identifier
unii: WQZ3G9PF0H
Arnica WellBELLIS PERENNIS, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLLIUM MT, CHAMOMILLA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, APIS MELLIFICA, ARNICA MONTANA, BELLADONNA, SYMPHYTUM OFFICINALE, HYPERICUM PERFORATUM.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 05258499752647581-e65c-4f43-bb61-600174bc8e7e2021-12-29WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: WQZ3G9PF0H
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: C9TD27U172
unii: W2469WNO6U
unii: 660YQ98I10
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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