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 66 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3338023a-171e-1e49-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Algonquin HanClean FoamBENZALKONIUM CHLORIDEWhisk Products, Inc.aad3246e-0ef3-4fce-ae11-10a1b5197b192025-06-09WarningsExact identifier
unii: F5UM2KM3W7
Everywhere Flushable WipesEVERYWHERE FLUSHABLE WIPESShenzhen Shierjie Biological Engineering Co., LTD371be299-5aaf-b9d7-e063-6294a90a87f52025-06-08WarningsExact identifier
unii: F5UM2KM3W7
Thyro T3 RescueSPONGIA TOSTA, IODIUM, FUCUS VESICULOSUS, BELLADONNA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, PARATHYROID GLAND (BOVINE), SELENIUM METALLICUM, THYROIDINUM (SUIS), HEPAR BOVINE, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, KIDNEY (SUIS), THYMUS (SUIS), LEVOTHYROXINUM, TRIIODOTHYRONINEThe Wellness Center for Research and Education99070720-7f30-4f80-a0ab-3b5eea95a58f2025-06-06WarningsExact identifier
unii: WQZ3G9PF0H
Zogics Foam Hand SanitizerBENZALAKONIUMZogics, LLC36e8b7a6-4e3b-378e-e063-6394a90a26522025-06-06WarningsExact identifier
unii: F5UM2KM3W7
Serene SleepESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOXThe Wellness Center for Research a2d5bbd0d-9b50-45ce-aa23-05bd05b546452025-06-06WarningsExact identifier
unii: G0R4UBI2ZZ
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: W2469WNO6U
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
unii: F5UM2KM3W7
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Aconitum NapellusACONITUM NAPELLUSBestmade Natural Products2993aeb3-a327-1b94-e063-6394a90a65962025-05-27WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products - Mullein Ear DropsBELLADONNA, CALENDULA, ECHINACEA, HYDRASTIS, MULLEIN OIL, VIOLA ODORATABestmade Natural Products299331bd-9318-6d80-e063-6294a90ab8892025-05-27WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
CamiliaMATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOTLaboratoires Boiron24246729-2d45-4d83-bc25-39db03e266d42025-05-27WarningsExact identifier
unii: G0R4UBI2ZZ
help it AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b22f423-eb11-445f-a484-9326c1fe3ad52025-05-27WarningsExact identifier
unii: F5UM2KM3W7
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2023-2024), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.1d35a8ab-c06b-478d-8f7b-dbe9c7dbb3d42025-05-27WarningsExact identifier
unii: U0NQ8555JD
Heart Small Intestine Meridian OpenerARSENICUM ALBUM, AURUM METALLICUM, BELLADONNA, CACTUS GRANDIFLORUS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, KALI CARBONICUM, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), PYROGENIUM, SPIGELIA ANTHELMIADeseret Biologicals, Inc.5b693acf-acfd-42d9-b7ac-7c7b5923ed612025-05-27WarningsExact identifier
unii: WQZ3G9PF0H
Immune SupportACONITUM NAPELLUS, ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, ASTRAGALUS MEMBRANACEUS, BAPTISIA TINCTORIA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2023-2024), LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SANGUINARIA CANADENSIS, SPLEEN (SUIS), SULPHUR, THUJA OCCIDENTALIS,Deseret Biologicals, Inc.8906ed6e-3a64-47c2-bc41-ae5101aff69d2025-05-27WarningsExact identifier
unii: U0NQ8555JD
Band Aid Antiseptic Cleansing LiquidBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEKenvue Brands LLCd2a6e0d2-5b9b-11c0-e053-2a95a90a4df02025-05-26WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only Antiseptic First AidBENZALKONIUM CHLORIDEAcme United Corporation35d06b38-55dd-e306-e063-6394a90aaf262025-05-23WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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