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 105 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B ForceECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, PROTEUS (MORGANI), SALMONELLA TYPHI NOSODE, CLOSTRIDIUM PERFRINGENSBioActive Nutritional, Inc.2eb4e898-4019-425a-9ef9-536f112b88f02024-03-05WarningsExact identifier
unii: WQZ3G9PF0H
PTS/Stress RemedyKALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALISDeseret Biologicals, Inc.05341147-789a-4844-9412-6a3044e5eb182024-03-04WarningsExact identifier
unii: U0NQ8555JD
Immune SupportECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, BAPTISIA TINCTORIA, SANGUINARIA CANADENSIS, ARISTOLOCHIA CLEMATITIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM, ASTRAGALUS MEMBRANACEUS, INFLUENZINUM (2022-2023), SPLEEN (SUIS), THYMUS,Deseret Biologicals, Inc.55e12503-4782-424a-8661-6107aa9838e22024-02-29WarningsExact identifier
unii: U0NQ8555JD
XtraCare Foam Antibacterial Hand Wash Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice Internationala9a1467c-abcc-4ccb-88f6-4302796097882024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice International9fa9d955-7167-4a0a-935b-2a600f439eb02024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International157a14bf-f46e-49f8-96f4-a6c472eb5cb82024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foaming Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry BlastBENZALKONIUM CHLORIDERejoice International45b3ca49-edb4-4840-b857-d24045494a3a2024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International4890f81e-7994-4ea2-9412-5614c405a2a32024-02-28WarningsExact identifier
unii: F5UM2KM3W7
XtraCare Foam Antibacterial Hand Wash Wild Berry BlastBENZALKONIUM CHLORIDERejoice International5c109f7c-1f4d-484a-b6ea-3bbcf572bbac2024-02-28WarningsExact identifier
unii: F5UM2KM3W7
SCRUBS Hand Sanitizer WipesBENZALKONIUM CHLORIDEITW Pro Brands067022d1-8ecd-a6ba-e063-6394a90a40f02024-02-22WarningsExact identifier
unii: F5UM2KM3W7
STRE PLUSALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), CHAMOMILLA, KALI IODATUM, LAC CANINUM, AGARICUS MUSCARIUS, AILANTHUS GLANDULOSUS, APIS MELLIFICA, ARGENTUM NITRICUM, BAPTISIA TINCTORIA, BARYTA MURIATICA, CALCAREA CARBONICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, STRAMONIUM, ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRADeseret Biologicals, Inc.8e03667e-ae6a-4930-b117-3b14d5d26cb22024-02-22WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Lung Large Intestine Meridian OpenerALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHURDeseret Biologicals, Inca5c17770-e1c0-48e7-8947-c0434c22cdab2024-02-21WarningsExact identifier
unii: G0R4UBI2ZZ
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
CoughIPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.4a8deb4a-9f26-46a9-8d99-99df36407f222024-02-19WarningsExact identifier
unii: U0NQ8555JD
AntisepticANTISEPTIC SPRAYDynarex Corporation118192ac-7173-09c5-e063-6394a90ad5502024-02-16WarningsExact identifier
unii: F5UM2KM3W7
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
unii: F5UM2KM3W7
Flu CareINFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEANewton Laboratories, Inc.115c4835-46e3-3b6f-e063-6394a90a2c802024-02-14WarningsExact identifier
unii: U0NQ8555JD
Flu CareINFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEANewton Laboratories, Inc.115d1ae4-bcfa-7fdd-e063-6394a90a36ad2024-02-14WarningsExact identifier
unii: U0NQ8555JD
InfluenzaINFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEANewton Laboratories, Inc.115edfbe-417b-08b3-e063-6394a90ae6ae2024-02-14WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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