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 22 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Cough Relief ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOTCOUGH RELIEFSchwabe North America, Inc.a95610e3-774b-4745-a2a4-fc3ba51ab4c52026-03-06WarningsExact identifier
unii: U0NQ8555JD
V Force HPARSENICUM ALBUM, BELLADONNA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOXBioActive Nutritional, Inc.415ce4af-40fa-4510-8b35-3da217c859f22026-03-06WarningsExact identifier
unii: WQZ3G9PF0H
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: WQZ3G9PF0H
Sambucus Cold Flu Relief ElderberrySAMBUCUS COLD FLU RELIEF ELDERBERRYSchwabe North Americadbcb3c3f-10a2-4e48-9fd9-bd6590c7239d2026-03-05WarningsExact identifier
unii: U0NQ8555JD
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
unii: F5UM2KM3W7
PneumoforceALTHAEA OFFICINALIS, NATRUM CARBONICUM, RHEUM (PALMATUM), VERBASCUM THAPSUS, ZINGIBER OFFICINALE, ACONITUM NAPELLUS, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, LOBELIA INFLATA, PHOSPHORUSBioActive Nutritional, Inc.a58c6a1a-ad3e-4055-8077-b6738105087d2026-03-05WarningsExact identifier
unii: C9TD27U172
unii: U0NQ8555JD
Cold Flu Relief ElderberryCOLD FLU RELIEF ELDERBERRYSchwabe North America27ec0362-b762-442e-ad82-1f17fe15858e2026-03-05WarningsExact identifier
unii: U0NQ8555JD
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: WQZ3G9PF0H
Bio Chem DetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, TRITICUM AESTIVUM, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CARBO VEGETABILIS, CINCHONA OFFICINALIS, CONIUM MACULATUM, MERCURIUS CORROSIVUS, PHOSPHORUS, SULPHUR, TABACUM, NITRICUM ACIDUM, AGARICUS MUSCARIUS,BioActive Nutritional, Inc.3f9bd6c8-6fc9-4af1-8263-ab42f99fba372026-03-05WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
unii: F5UM2KM3W7
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: G0R4UBI2ZZ
SSDC Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.c4063012-34ab-4409-baf4-9e3d8f3e20112026-03-04WarningsExact identifier
unii: F5UM2KM3W7
Sciatic Nerve FormulaAESCULUS HIPPOCASTANUM, AMMONIUM MURIATICUM, ARSENICUM ALBUM, BELLADONNA, CAPSICUM ANNUUM, CAUSTICUM, COLCHICUM AUTUMNALE, COLOCYNTHIS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, IGNATIA AMARA, KALMIA, MAGNESIA PHOSPHORICA, RHUS TOX AND RUTA GRAVEOLENS.King Bio Inc.23ca6b5a-c4ca-41df-8dec-323e6e26d5342026-03-04WarningsExact identifier
unii: WQZ3G9PF0H
Sleep AidACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA, AND VALERIANA OFFICINALIS.King Bio Inc.794b7e4f-b084-4aee-8c07-96bac459d6982026-03-04WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals of New York LLCcd56e147-92d6-46ce-ae00-63fac08d49b52026-03-03Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SSDC ANTIBACTERIAL FOAM HANDSOAPBENZALKONIUM CHLORIDEEcolab Inc.a2a4e9d1-d63a-476b-a048-d360104e36882026-03-03WarningsExact identifier
unii: F5UM2KM3W7
Pain ReliefARNICA MONTANA, BELLADONNA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, MAGNESIA PHOSPHORICA, SANGUINARIA CANADENSIS, SALIX ALBANaturalCare6eba2caa-958f-47a1-823c-c73bbb1d7fa92026-03-02WarningsExact identifier
unii: WQZ3G9PF0H
Benzalkonium chlorideBENZALKONIUM CHLORIDEOld East Main Co.4769b25a-1cc5-5d37-e063-6294a90a6fbb2026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDEOld East Main Co.48e813ce-3893-b95f-e063-6294a90a18f22026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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