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 24 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 660YQ98I10
American Red Cross Antibacterial BarBENZALKONIUM CHLORIDEMy Imports Usa, LLCeab6bee4-e780-4f0d-aa9c-a0111f033b322026-02-23WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions2d67fc67-c99f-4df2-a1e7-4d369cce12c22026-02-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
AntibacterialBENZALKONIUM CHLORIDEMeijer, Inc.d450c423-00fa-4bb7-a0be-c14412a45e282026-02-20Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Kids Cough and Mucus Nighttime Grape FlavorRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Consumer Health Inc.d83e7877-f599-b364-e053-2995a90ab35f2026-02-19WarningsExact identifier
unii: G0R4UBI2ZZ
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.64c7d808-aaa0-4b8b-8fef-6285059939782026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.8fbbc798-ac00-4755-a2c2-5cd5b5c01ae42026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.df4dbf38-669a-441a-bd6e-f5cc490d17d22026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.fbfb9940-0c17-4fdf-81f5-406d614da8722026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antiseptic Foaming Hand SanitizerBENZALKONIUM CHLORIDETarget Corporation93d6e4df-9428-4557-b251-c7aa9bda34122026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDES. P. Richards Company9223a236-9e9e-42eb-a945-dfe629e4ae3f2026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
CeleragesicACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), ECHINACEA PURPUREA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MILLEFOLIUM, NADIDUM, PANTOTHENIC ACID, RHUS TOX, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALEDeseret Biologicals, Inc.18e573b8-dd8d-432a-90c3-84b8929a40392026-02-18WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Hand WashBENZALKONIUM CHLORIDEWalmart Inc.25d227f8-2238-4f6f-aa40-b314d0179d882026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Light Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%United Natural Foods, Inc. dba UNFI36738761-293e-4864-bc08-87a5075e1ccf2026-02-17WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd902026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDE 0.13%Uline57c7bf8f-c17a-41b5-9b66-e4d16d6650a72026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEULINE5a4d6fb7-486a-448c-b379-726adf60e4112026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WashBENZALKONIUM CHLORIDE 0.13%Uline9e7a97a0-f3dd-40cf-b25e-8ebb656939262026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Foaming HandBENZALKONIUM CHLORIDEVeritiv Operating Company3b4dbfd0-f275-3502-e063-6294a90a84862026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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