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 113 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shallow Breathing FormulaARALIA QUINQUEFOLIA, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, IPECACUANHA, BLATTA ORIENTALIS, ARSENICUM ALBUM, CUPRUM METALLICUMNutritional Specialties, Inc.a470ffff-c479-4867-aa3f-f009032b26d72023-10-12WarningsExact identifier
unii: U0NQ8555JD
Lymphastat BBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, FERRUM PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, COLIBACILLINUM CUM NATRUM MURIATICUM, PYROGENIUMEnergique, Inc.28df9ed4-28fa-4582-945b-18b31e73740a2023-10-10WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Lymphastat BBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, FERRUM PHOSPHORICUM, LACHESIS MUTUS, PHOSPHORUSEnergique, Inc.3a1f761e-eb12-41d8-b185-46da39497b082023-10-10WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
unii: F5UM2KM3W7
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 660YQ98I10
BHI Spasm PainATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, AND CUPRIC SULFATEMediNatura Inc3e117ea6-bbb2-4b77-b3ce-01572e6d71c12023-09-28WarningsExact identifier
unii: U0NQ8555JD
T-Relief Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT, ACONITUM NAPELLUS, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, ARNICA MONTANA, BELLIS PERENNIS AND HYPERICUM PERFORATUMMediNatura Inc01804104-32c2-4011-a2e4-0f4e74bd974d2023-09-28WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
T-Relief Extra Strength GelACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Ince4bf2e39-5635-4797-8519-7e115e8b1a272023-09-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
T-ReliefACHILLEA MILLEFOLIUM, HYPERICUM PERFORATUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA, UNSPECIFIED, MATRICARIA RECUTITA, ATROPA BELLADONNA,COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS,ARNICA MONTANA, AND RUTA GRAVEOLENS FLOWERING TOPMediNatura Inc1fcfd0a5-b4ff-4546-e054-00144ff8d46c2023-09-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
T-Relief Extra Strength CreamARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA UNSPECIFIED, ACONITUM NAPELLUS, ACHILLEA MILLEFOLIUM, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, BELLIS PERENNIS, RUTA GRAVEOLENS FLOWERING TOP, BAPTISIA TINCTORIA ROOT, COMFREY ROOT AND HYPERICUM PERFORATUMMediNatura Inc12f6cf2f-a924-42b1-9ca0-c360c7a592442023-09-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
T-ReliefACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Incedb2fe62-e990-4cef-8600-9d1b85bffa5a2023-09-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
TraumeelACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOTMediNatura Incc9962e63-3c30-4c62-9caf-91f663c7eeaa2023-09-26WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
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.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
CardCareECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.Newton Laboratories, Inc.06342201-f0b4-de0d-e063-6294a90a56212023-09-25WarningsExact identifier
unii: U0NQ8555JD
Pancreas SarcodeCHAMOMILLA, GLYCYRRHIZA GLABRA, SYZYGIUM JAMBOLANUM, VACCINIUM MYRTILLUS, ACETICUM ACIDUM, CONDURANGO, PHASEOLUS, SARSAPARILLA (SMILAX REGELII), PANCREAS SUIS, URICUM ACIDUMNutritional Specialties, Inc.56a6dbc1-3a6b-444f-8082-1999a64e529c2023-09-25WarningsExact identifier
unii: G0R4UBI2ZZ
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionse1670127-c551-441b-bac4-39f10a6d156f2023-09-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
T-Relief Extra StrengthARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING, HAMAMELIS VIRGINIANA ROOT BARK/STEM, BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS, ECHINACEA, UNSPECIFIED, ACONITUM NAPELLUS, MATRICARIA CHAMOMILLA, ACHILLEA MILLEFOLIUM, ATROPA BELLADONNA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc97959b87-690d-45c1-9319-c17cdfa850202023-09-18WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.a9910e09-5aea-4ee1-a35e-ae4abf8b80b42023-09-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionsf1af7e05-68ba-438e-a63b-cd8c23960c852023-09-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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