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 27 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
enMotion Antimicrobial with Moisturizers, Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LPb68252e4-ac4d-49e5-9f21-5f97c860e8f02026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial with Moisturizers, Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LPb5a2429f-7a31-424d-8174-12dff6d87a7d2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Pacific Blue Ultra Antimicrobial Pacific CitrusBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP4fc3122a-16c0-4e2c-aebb-b266857781172026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Terramed Just Think Comfort Armor Antibacterial Cleansing BarBENZALKONIUM CHLORIDERida LLC68e59a77-6a0c-42e2-a6a9-1353470d2e082026-02-04WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEPermatexcfd3279e-9584-49d7-bf4b-6ef00d501d9b2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
RoyceDerm Antibacterial Body WashBENZALKONIUM CHLORIDE 0.13%RoyceDerm LLC4a0c66b1-5a6f-b9b9-e063-6294a90a3d772026-02-04WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals5c2e888c-2f1e-4d5a-a456-20774ca833022026-02-04Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEMajor Pharmaceuticals7d74652b-3513-4ebb-8b47-10b3603d04a72026-02-04Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Hand WashBENZALKONIUM CHLORIDEDemoulas Super Markets, Inc3fe61130-9ec2-4e71-b147-320a81c4344c2026-02-03Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Escudo Ultra-Protect OriginalBENZALKONIUM CHLORIDEIndelpa, Inc1cd4c38f-8156-bd74-e063-6394a90a9f562026-02-03WarningsExact identifier
unii: F5UM2KM3W7
Escudo Ultra-Protect Soft CareBENZALKONIUM CHLORIDEIndelpa, Inc.1cc4b68b-dceb-3fab-e063-6294a90ab1122026-02-03WarningsExact identifier
unii: F5UM2KM3W7
NerveFixACONITUM NAPELLUS, BELLADONNA, CANTHARIS, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, HYPERICUM PERFORATUM, SPIGELIA ANTHELMIANaturalCare92326b54-cac9-4fb2-ae48-120a0dcbbe562026-02-03WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
unii: F5UM2KM3W7
Foaming HandBENZALKONIUM CHLORIDECintas Corporation17fb34e7-c9e6-41aa-991f-bb54c84ed79c2026-02-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
RELEEV Cold Sore TreatmentBENZALKONIUM CHLORIDEMerix Pharmaceutical Corp.fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf2026-02-02WarningsExact identifier
unii: F5UM2KM3W7
Cough and Mucus NightANTIMONIUM TARTARICUM, AVENA SATIVA, BRYONIA (ALBA), CHAMOMILLA, DROSERA (ROTUNDIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, STANNUM METALLICUM, SULPHURNaturalCaref27e3a7f-78a3-4003-95fc-0b32671df4432026-02-02WarningsExact identifier
unii: G0R4UBI2ZZ
CLUB WIPES USA SANITIZING WIPESBENZALKONIUM CHLORIDEBubble Marketing LLCa0e4b04c-2227-49d2-8ccc-c7647b07cb022026-02-02WarningsExact identifier
unii: F5UM2KM3W7
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDERising Pharma Holdings, Inc.947c11ca-ca0c-42df-8cc5-3db06458ca5b2026-02-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SUTABSODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.c020e973-dccf-4862-999e-17db6209a48a2026-01-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Aldi, LLCbcde5681-5bc6-41a7-890e-27ba6f4e4be62026-01-29Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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