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 117 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LY-COANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.47140966-5b49-432d-bf35-bcae14f420822023-06-01WarningsExact identifier
unii: 660YQ98I10
Lyme and Co-Infection NosodeANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.f6186157-256f-4454-b122-f7665e3286f42023-06-01WarningsExact identifier
unii: 660YQ98I10
BHI BackAMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAFMediNatura Incaa622a5b-16de-4098-9c3f-d7569f7d2c2f2023-05-23WarningsExact identifier
unii: G0R4UBI2ZZ
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TOUCH Sanitizing Germ Block, Unscented, 1oz (28.35g)BENZALKONIUM CHLORIDERelevo, Inc.c3ba1f21-51d9-c4ee-e053-2995a90aa0422023-05-16WarningsExact identifier
unii: F5UM2KM3W7
Backache ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANAHyland's Inc.a51452b3-0aba-6928-e053-2995a90a16192023-05-10WarningsExact identifier
unii: U0NQ8555JD
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: G0R4UBI2ZZ
BHI Flu PlusACONITUM NAPELLUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, AND ZINCMediNatura Inc8d73082d-a1bc-4e76-9714-49f718b5850b2023-04-13WarningsExact identifier
unii: U0NQ8555JD
ChamomillaCHAMOMILLANewton Laboratories, Inc.f912a32e-9bc9-c195-e053-6294a90a3e202023-04-11WarningsExact identifier
unii: G0R4UBI2ZZ
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
StressCalmACONITUM NAPELLUS, ATROPA BELLADONNA, CHELIDONIUM MAJUS, CALENDULA OFFICINALIS FLOWERING TOP, VIBURNUM OPULUS BARK, ABRUS PRECATORIUS SEEDBoironddcbbaae-ca20-9e18-e053-2a95a90a267f2023-04-05Exact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Belladonna and OpiumATROPA BELLADONNA AND OPIUMPadagis US LLC8301e76b-134a-43d2-a7dc-c600ccf2695c2023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WQZ3G9PF0H
BelladonnaATROPA BELLADONNABoiron84767820-0e21-3f25-e053-2a91aa0a6a182023-03-28Exact identifier
unii: WQZ3G9PF0H
BelladonnaATROPA BELLADONNABoiron8476ccac-b35e-8608-e053-2991aa0a6ac52023-03-27Exact identifier
unii: WQZ3G9PF0H
T-ReliefARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc2bd442ca-0bbe-0bc3-e054-00144ff8d46c2023-03-21WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
TraumedARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc8cd4745f-2f4b-4cdf-868b-c5a089a165992023-03-21WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
TraumexARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc335c8bec-f0c3-4b95-a6a6-5fda262be0e62023-03-20WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Myco Immuno NosodeDU HUO (ANGELICA PUBESCENS), ANGELICA ARCHANGELICA, KALI MURIATICUM, RADIX SILERIS (SAPOSHNIKOVIA DIVARICATA), YUCCA FILAMENTOSA, ACHYRANTHES BIDENTATA, ANGELICA SINENSIS, LIGUSTICUM PORTERI, PANAX GINSENG, RHUS TOX, HYDRASTIS CANADENSIS, UNCARIA TOMENTOSA, CARTILAGO SUIS, HORDEUM VULGARE, OXALICUM ACIDUM, ARNICA MONTANA, LATRODECTUS MACTANS, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, BORRELIA BURGDORFERI, BABESIA MICROTINutritional Specialties, Inc.34dc93af-0c39-4e06-a8d6-9e1ccc77aa232023-03-17WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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