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 76 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDE EXTENDED-RELEASENCS HealthCare of KY, LLC dba Vangard Labsc684758c-16f0-4bd9-b719-1aae64b7907f2025-01-16Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Jade Antibacterial HandBENZALKONIUM CHLORIDEWhisk Products, Inc.6386cc10-3699-47c8-aea7-01adbff826222025-01-15WarningsExact identifier
unii: F5UM2KM3W7
FOAM-BAC Antibacterial HandBENZALKONIUM CHLORIDEWhisk Products, Inc.f7ab10b8-1750-436f-a762-6d4d2ca522422025-01-15WarningsExact identifier
unii: F5UM2KM3W7
Natural Extensions Antibacterial Foaming HandBENZALKONIUM CHLORIDEBenco Dentalc51f4430-6877-4f46-a5c7-d61b30b908222025-01-15WarningsExact identifier
unii: F5UM2KM3W7
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUMDeseret Biologicals, Inc.1a3edb9d-e571-4275-b56e-d2489da11e762025-01-14WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Antiseptic TowelettesBENZALKONIUM CHLORIDECMC Group Inc.d7470f98-4278-415b-92e7-9eca2036bc092025-01-13WarningsExact identifier
unii: F5UM2KM3W7
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
unii: F5UM2KM3W7
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
unii: F5UM2KM3W7
D-4QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.45577059-73f4-4302-b299-3e356aaf959a2025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-8SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIADNA Labs, Inc.bc817ccf-f11c-4875-9e14-5a249f92c5032025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-6ACONITUM NAPELLUS, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, CAUSTICUM, CAMPHOR (NATURAL), EUCALYPTUS GLOBULUS LEAF, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, AND SCHOENOCAULON OFFICINALE SEEDDNA Labs, Inc.27f58993-c611-4dc7-ac8e-0132f0a4fcef2025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-5SILVER NITRATE, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM SPORE, SEMECARPUS ANACARDIUM JUICE, SCROPHULARIA NODOSA, ATROPA BELLADONNA, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, AND CHELIDONIUM MAJUSDNA Labs, Inc.c286e9b3-51c6-4633-aef1-cda2505c1fa02025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
D-42HORSE CHESTNUT, ATROPA BELLADONNA, CALCIUM FLUORIDE, MILK THISTLE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, DAPHNE MEZEREUM BARK, ANEMONE PRATENSIS, CLAVICEPS PURPUREA SCLEROTIUM, VIPERA BERUS VENOM, AND BOS TAURUS PLACENTADNA Labs, Inc.400cbb19-5475-43ee-8630-608e673dc9862025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-30STRONTIUM SALICYLATE, METHENAMINE, COLCHICUM AUTUMNALE BULB, BLACK COHOSH, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, SOLANUM DULCAMARA WHOLE, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.0e74e654-4bda-4969-89be-8ab89014bce22025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-9CUPRIC ACETATE, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, DROSERA ROTUNDIFOLIA, ATROPA BELLADONNA, HYOSCYAMUS NIGER, ONION, CORALLIUM RUBRUM EXOSKELETON, AND LOBARIA PULMONARIADNA Labs, Inc.15cb964d-086f-40a6-8056-5f149f04ab4c2025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-32NITRIC ACID, ATROPA BELLADONNA, PILOCARPUS JABORANDII WHOLE, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SAMBUCUS NIGRA FLOWERING TOP, SEPIA OFFICINALIS JUICE, SANGUINARIA CANADENSIS ROOT, VERATRUM ALBUM ROOT, AND SAGEDNA Labs, Inc81bb16d9-9c93-48d3-85ca-81c118a1c4a02025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-33ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINCDNA Labs, Inc.26f9bf6d-6038-42e8-b8c1-6c94ac4929af2025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
D-70ACONITUM NAPELLUS, SIMABA CEDRON SEED, CITRULLUS COLOCYNTHIS FRUIT PULP, KALMIA LATIFOLIA LEAF, AND VERBASCUM THAPSUSDNA Labs, Inc.3f6a830d-3406-4d2b-8673-0e5df9caa3ec2025-01-13WarningsExact identifier
unii: C9TD27U172
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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