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 72 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moxie Hand WipesBENZALKONIUM CHLORIDESkaffles Group17cd6c1a-7b31-3975-e063-6294a90a41c52025-03-07WarningsExact identifier
unii: F5UM2KM3W7
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 660YQ98I10
XTRABENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.27df3fce-3958-d4ea-e063-6394a90a17852025-03-06WarningsExact identifier
unii: F5UM2KM3W7
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
unii: F5UM2KM3W7
BART PLUSACONITUM NAPELLUS, APIS MELLIFICA, ARBUTUS ANDRACHNE, ARNICA MONTANA, ARSENICUM ALBUM, COCCULUS INDICUS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, GUNPOWDER, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALMIA LATIFOLIA, LAC CANINUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, STRAMONIUM, TELLURIUM METALLICUM, THYROIDINUM (SUIS), VERATRUM ALBUMDeseret Biologicals, Inc.4de3d6d4-108c-41b9-8aa7-4225ce494d782025-03-04WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products BM233ACONITE, BELLADONNA, DROSERA, IPECAC, MEPHITIS, THYMUS, VERAT ALBBestmade Natural Products2f820355-5c54-3549-e063-6394a90a147e2025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bestmade Natural Products BM234ACONITE, ARS. ALB, BELLADONNA, BRYONIA, EUP. PERF, GELSEMIUM, PYROGENUMBestmade Natural Products2f825212-ff1f-6037-e063-6394a90a0fca2025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products BM236ARG. MET, ARNICA MONT, BRYONIA, CHAMOMILLA, RANUNCULUS BULB, RHUS TOX, RUTA GRAVBestmade Natural Products2f82b461-7059-eacf-e063-6294a90a2ca92025-03-04WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
Bestmade Natural Products BM241BELLADONA, CEANOTHUS, CICUTA VIR, COCCULUS IND, GELSEMIUM, GRATIOLABestmade Natural Products2f84205f-a632-09bd-e063-6394a90a89402025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
Bestmade Natural Products BelladonnaBELLADONNABestmade Natural Products2f863877-652f-91ef-e063-6294a90a96de2025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
unii: F5UM2KM3W7
Sambucus Cold Flu Relief Hot Drink Lemon FlavoredPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, SEMPERVIRENS, PHOSPHORUSUniversal Synergetics, Inc2ca2064a-2011-48fb-a47a-837ea3fc9bf62025-03-04WarningsExact identifier
unii: U0NQ8555JD
Ben E. Keith FIHSBENZALKONIUM CHLORIDEBen E. Keith Foods4ca21370-1ecf-42c6-9c32-79cf994c336b2025-03-03WarningsExact identifier
unii: F5UM2KM3W7
Bestmade Natural Products BM218ACONITE, HEPAR SULPH, SPONGIA, MOSCHUS, SAMBOCUSBestmade Natural Products2f6f3f24-ceff-3194-e063-6394a90a72e42025-03-03WarningsExact identifier
unii: U0NQ8555JD
Algonquin HanClean FoamBENZALKONIUM CHLORIDEWhisk Products, Inc.2f73c3a7-426e-51f4-e063-6394a90aad4f2025-03-03WarningsExact identifier
unii: F5UM2KM3W7
RexallEar Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURDolgencorp LLC59cfc7b4-faf0-4794-8911-d8745e12c6b82025-02-28WarningsExact identifier
unii: G0R4UBI2ZZ
Meijer Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURMeijer Distribution Inc8ff0fa61-964e-77a8-e053-2a95a90a2d3a2025-02-28WarningsExact identifier
unii: G0R4UBI2ZZ
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsbf632e1d-73f3-4df1-ad12-e555fa6a56e92025-02-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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