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 75 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db425ca-f80d-46e9-e053-2a95a90addc42025-01-28WarningsExact identifier
unii: C9TD27U172
unii: U0NQ8555JD
Kali Muriaticum Kit RefillPOTASSIUM CHLORIDEWashington Homeopathic Products099223af-a3f6-c370-e063-6394a90aa17f2025-01-28WarningsExact identifier
unii: 660YQ98I10
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
unii: F5UM2KM3W7
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
DiarrheaAESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUSNewton Laboratories, Inc.9d7322da-c2fb-0fc3-e053-2a95a90ac70b2025-01-27WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db1327c-6746-76cb-e053-2995a90a6e272025-01-27WarningsExact identifier
unii: C9TD27U172
unii: U0NQ8555JD
Foaming AntibacterialBENZALKONIUM CHLORIDESam's West, Inc.1e13036a-f2e6-2d09-e063-6394a90a38022025-01-24WarningsExact identifier
unii: F5UM2KM3W7
Olibanum Belladonna comp.OLIBANUM BELLADONNA COMP.Uriel Pharmacy, Inc2c778131-9962-879a-e063-6394a90a56bb2025-01-24WarningsExact identifier
unii: WQZ3G9PF0H
Little Buddy in a Little TubbyHAND SANITIZING TOWELETTESContinental Research Corpf4fac964-4a27-335d-e053-2a95a90ac4eb2025-01-23WarningsExact identifier
unii: F5UM2KM3W7
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa9ca8aaa-ea76-7eb5-e053-2995a90adef92025-01-23WarningsExact identifier
unii: F5UM2KM3W7
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa8c6ef84-b072-72ee-e053-2995a90aa1112025-01-23WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rxf988aa11-60ef-411e-e053-6294a90a522a2025-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDirect_Rx946b9568-671d-172a-e053-2a95a90ac8272025-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Nuby Soothing GelSOOTHING GELNINGBO RAFFINI IMPORTS & EXPORTS CO LTD290692c0-54d9-d401-e063-6294a90a705a2025-01-21WarningsExact identifier
unii: G0R4UBI2ZZ
Up and Up Max Pain Relieving CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDETARGET CORPORATION2c3e72eb-5d98-1f3f-e063-6394a90ab00c2025-01-21WarningsExact identifier
unii: F5UM2KM3W7
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
unii: F5UM2KM3W7
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: U0NQ8555JD
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
unii: F5UM2KM3W7
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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