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 133 of 134 · 2,668 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Recharge Sanitizing Towlette Organic Peppermint SurgeBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC3f8ae3b7-a2c4-48e8-a6eb-a3e38c5797a02018-01-29WarningsExact identifier
unii: F5UM2KM3W7
Relax Sanitizing Towlette Organic Lavender CalmBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC70914fc3-1ada-450d-a4eb-7db283030d5f2018-01-29WarningsExact identifier
unii: F5UM2KM3W7
Lactated RingersSODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEBaxter Healthcare Company5215ec33-8cfe-4885-ae92-e6a12100bd272018-01-02Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
H-Rosacea FormulaBELLADONNA, NUX VOMICAHealing Natural Oils LLCf00b0028-4340-4219-8890-f66590a2a04d2017-12-27WarningsExact identifier
unii: WQZ3G9PF0H
H-Joint and Muscle FormulaARNICA MONTANA, BELLIS PERENNIS, CHAMOMILLAHealing Natural Oils LLC9f9ea8b1-2dd7-46b3-9f8f-5668f0279f002017-12-27WarningsExact identifier
unii: G0R4UBI2ZZ
H-Fissures FormulaCALENDULA OFFICINALIS, CHAMOMILLAHealing Natural Oils LLCaa2b25cc-5bf3-4aee-951f-497b8ae69f072017-12-27WarningsExact identifier
unii: G0R4UBI2ZZ
Byotrol Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC09edbc17-c443-4b0d-9c28-c4b8233c4d1a2017-12-14WarningsExact identifier
unii: F5UM2KM3W7
First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies25ebf112-8ac3-4402-9a87-00e454ab7efa2017-11-30WarningsExact identifier
unii: F5UM2KM3W7
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: 660YQ98I10
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: U0NQ8555JD
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardio TonicKALI MURIATICUM, KALI PHOSPHORICUM, PLANTAGO MAJOR, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, HEART (BOVINE), L-CARNITINE, L-VALINE, THYROIDINUM (SUIS), ABROTANUM (ARTEMISIA ABROTANUM), IODIUM, LECITHIN, SPIGELIA ANTHELMIABioActive Nutritional, Inc.2c252ba6-f147-4c22-b432-cd603a9623ac2017-08-14WarningsExact identifier
unii: W2469WNO6U
unii: 660YQ98I10
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: G0R4UBI2ZZ
IndustrotoxGLYCYRRHIZA GLABRA, PLANTAGO MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ARNICA MONTANA, ASCLEPIAS TUBEROSA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, LAPPA MAJOR, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, SYMPHYTUM OFFICINALE, HEPAR SUIS, LUNG (SUIS), LYMPH NODE (SUIS)BioActive Nutritional, Inc.0722085a-1478-4667-b0c6-3315cff25b082017-06-16WarningsExact identifier
unii: W2469WNO6U
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC1b225968-aff7-4959-89e1-a8edabb4d6702017-05-22WarningsExact identifier
unii: F5UM2KM3W7
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Senility HPANACARDIUM ORIENTALE, BELLADONNA, HYOSCYAMUS NIGER, VERATRUM ALBUM, BARYTA CARBONICA, LACHESIS MUTUS, PHOSPHORUS, STRAMONIUMBioActive Nutritional, Inc.214cf942-5277-4f4b-af7d-a9fcc6c8bd372017-02-23WarningsExact identifier
unii: WQZ3G9PF0H
CVS Pain Relieving First Aid AntisepticLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy454b1773-eda8-5610-e054-00144ff88e882017-01-04WarningsExact identifier
unii: F5UM2KM3W7
CVS Pharmacy Sensitive Medicated CreamBENZOCAINE, BENZALKONIUM CHLORIDECVS Pharmacy454c3458-7e40-0e5e-e054-00144ff8d46c2017-01-04WarningsExact identifier
unii: F5UM2KM3W7
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: W2469WNO6U

Reported adverse events (FAERS/openFDA)#

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