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 92 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle/Tendon Pain and Stress ReliefCALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)Energique, Inc.4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f2024-10-29WarningsExact identifier
unii: W2469WNO6U
OvaparANGELICA ARCHANGELICA, CAULOPHYLLUM THALICTROIDES, XANTHOXYLUM FRAXINEUM, OOPHORINUM (SUIS), APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, SEPIA, MUREX PURPUREAEnergique, Inc.13ecc450-0ae3-46d3-8cc7-915c74c3361a2024-10-29WarningsExact identifier
unii: WQZ3G9PF0H
OtotoneBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)Energique, Inc.c34e0abf-02d8-4dee-a89b-3f61ab593dc32024-10-29WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
unii: F5UM2KM3W7
AnxiovitaACONITUM NAPELLUS, ANACARDIUM ORIENTALE, CEREBRUM, HYPERICUM PERFORATUMRUBIMED AG258c677b-1a0a-4315-ba0c-4d9892f0534d2024-10-29WarningsExact identifier
unii: U0NQ8555JD
Emvita 16ACONITUM NAPELLUS, AMBRA GRISEA, ESCHSCHOLTZIA, SECALE, THYMUS GLAND, ZINC METRUBIMED AGb681ec83-cc7f-4c8e-80a8-0aa0b1cc07592024-10-29WarningsExact identifier
unii: U0NQ8555JD
Emvita 20APIS MELLIFICA, BELLADONNA, CANTHARIS, HYPOPHYSIS, IGNATIA AMARA, MAG CARB, PHOSPHORUS, PULSATILLARUBIMED AG79aa12bc-4279-485f-9253-faacc4d2199c2024-10-29WarningsExact identifier
unii: WQZ3G9PF0H
Emvita 21ARSENICUM ALB, CHAMOMILLA, HYPOPHYSIS, LACHESIS MUTUS, MAG CARBRUBIMED AG46ddfe55-5189-4e43-9e30-44a33bb4a7a72024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Emvita 24CHAMOMILLA, CROTALUS HORRIDUS, HYPOPHYSIS, IGNATIA AMARA, PHOSPHORUSRUBIMED AGbea3529e-4757-433c-b005-999f2ed5ab322024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Chavita 3ARGENTUM MET, CHAMOMILLA, CHELIDONIUM MAJUS, NUX VOMICA, PANCREAS SUIS, LYCOPODIUM, ZINGIBERRUBIMED AG4895e274-7fa7-4f2f-a536-fa883505ead42024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
SimvitaCEREBRUM, CHAMOMILLA, EPHEDRA VULGARIS, SECALERUBIMED AG82331ea9-bd10-4f06-8c7c-d4ef47d585d62024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack55747ef3-9437-4bdc-9ebd-a74d8e2de1cf2024-10-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Menopause HPBELLADONNA, LACHESIS MUTUS, MANGANUM ACETICUM, NUX VOMICA, PULSATILLA (PRATENSIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDISEnergique, Inc.6412a5f1-5587-4d4e-8d3f-6929794154362024-10-29WarningsExact identifier
unii: WQZ3G9PF0H
Multi-Cell SaltKALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEAEnergique, Inc.dad00225-b3ac-4e36-a856-19b0faf42c422024-10-29WarningsExact identifier
unii: 660YQ98I10
Softsoap AB Sensitive Rose Water and Aloe LHSBENZALKONIUM CHLORIDEColgate-Palmolive Companye48e3e21-304d-4a12-be87-a5aff832b62a2024-10-29WarningsExact identifier
unii: F5UM2KM3W7
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 660YQ98I10
Numbness HPACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ARNICA MONTANA, COFFEA CRUDA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PHOSPHORUS, PLUMBUM METALLICUMEnergique, Inc.0c4ba547-b4b4-41d0-8a6b-1141ff5f94532024-10-29WarningsExact identifier
unii: U0NQ8555JD
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Nerve Pro HPPLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, COLOCYNTHIS, MAGNESIA PHOSPHORICA, AGARICUS MUSCARIUS, HYPERICUM PERFORATUM, ARGENTUM NITRICUM, CARBONEUM SULPHURATUM, CURARE, THALLIUM METALLICUMEnergique, Inc.846d5805-6f82-4cb4-b64c-adba6d3004e72024-10-29WarningsExact identifier
unii: W2469WNO6U
IndustristatPLANTAGO MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CADMIUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.1279a90c-6263-4ca6-87e1-4b31a36854bb2024-10-28WarningsExact identifier
unii: W2469WNO6U

Reported adverse events (FAERS/openFDA)#

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