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 90 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYMMETRY ANTIMICROBIAL FOAMING HAND WASH w/Benzalkonium ChlorideBENZALKONIUM CHLORIDEBuckeye International, Inc.e2891cfb-9664-bd02-e053-2995a90ab8d12024-11-15WarningsExact identifier
unii: F5UM2KM3W7
Symmetry Non-Alcohol Foaming Hand Sanitizer with Allantoin and AloeBENZALKONIUM CHLORIDEBuckeye International, Inc.2750f62c-e650-428a-b070-5c13ff8e378e2024-11-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antiseptic ToweletteBENZALKONIUM CHLORIDEUNCHARTED SUPPLY COMPANY, INC.25840eb7-9317-439f-a8e8-a7d889c060d22024-11-14WarningsExact identifier
unii: F5UM2KM3W7
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackf22606a5-ac9f-44fc-bb7b-08f3cf56c9992024-11-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dial advanced clean Antibacterial goldBENZALKONIUM CHLORIDEHenkel Corporationf7f6d050-4054-d3f9-e053-6294a90a61962024-11-11WarningsExact identifier
unii: F5UM2KM3W7
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
unii: F5UM2KM3W7
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
unii: F5UM2KM3W7
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
unii: F5UM2KM3W7
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
unii: F5UM2KM3W7
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 660YQ98I10
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
Mood SwingsACONITUM NAPELLUS, ADRENALINUM, CAMPHORA, CIMICIFUGA RACEMOSA, CROCUS SATIVUS, DOPAMINE HYDROCHLORIDE, HYOSCYAMUS NIGER, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI BROMATUM, LACHESIS MUTUS, LITHIUM CARBONICUM, OENANTHE CROCATA, PLATINUM METALLICUM, PULSATILLA (PRATENSIS), SEROTONIN (HYDROCHLORIDE), STRAMONIUM, TARENTULA HISPANA, THYROIDINUM (SUIS), ZINCUM METALLICUMDeseret Biologicals, Inc.fe96a41e-c477-4d96-acfa-0e28d129ca2b2024-11-08WarningsExact identifier
unii: U0NQ8555JD
AnXiousACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ANGELICA SINENSIS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CACAO, CALCAREA CARBONICA, CLEMATIS VITALBA, FLOS, COCCULUS INDICUS, GELSEMIUM SEMPERVIRENS, GLANDULA SUPRARENALIS SUIS, HELIANTHEMUM NUMMULARIUM, FLOS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, LITHIUM CARBONICUM, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PIPER METHYSTICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALISDeseret Biologicals, Inc.6398c061-e20f-4a98-8978-ddb15039e9e62024-11-08WarningsExact identifier
unii: U0NQ8555JD
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
DoveMEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BARConopco Inc. d/b/a/ Unileverb9e61a03-e000-50ab-e053-2a95a90a32102024-11-07WarningsExact identifier
unii: F5UM2KM3W7
DoveDOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASHConopco Inc. d/b/a/ Unileverb9f8cb31-560c-79e0-e053-2a95a90a39ae2024-11-07WarningsExact identifier
unii: F5UM2KM3W7
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unilevered234413-777a-9c82-e053-2a95a90a6f982024-11-07WarningsExact identifier
unii: F5UM2KM3W7
DoveCARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASHConopco Inc. d/b/a/ Unilevered24b320-27fc-9714-e053-2995a90a79a62024-11-07WarningsExact identifier
unii: F5UM2KM3W7
FinazolFERROUS FUMARATE, FOLATEPureTek Corporation24290823-022a-433b-e063-6394a90a8fd02024-11-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Nice n Clean Wipes Sani-Hands Antibacterial Hand WipesBENZALKONIUM CHLORIDE HAND WIPESNice-Pak Products, Inc.b6e6577c-c172-f3df-e053-2a95a90ac5152024-11-07WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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