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 132 of 134 · 2,668 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
E.N.V.BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALBZorex International838498ba-cab9-4e1b-a567-e7f1862b7fbb2018-12-21WarningsExact identifier
unii: WQZ3G9PF0H
GUNA-RHINO NOSEAPIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - MELILOTUS - ONION - PLANTAGO MAJOR - ROSA CANINA FRUIT - SILVER NITRATE -Guna spa5baeb698-1735-4586-9984-2a2cb0da871a2018-12-21WarningsExact identifier
unii: W2469WNO6U
GUNA-DERMOALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -Guna spa8bf717eb-fe46-4066-b124-eb715ffc15422018-12-21WarningsExact identifier
unii: W2469WNO6U
unii: WQZ3G9PF0H
GUNA-HEMORRHOIDSACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELTATUM ROOT - PORK LIVER - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa0fd0dcef-79c6-4489-a533-996aa5331d9c2018-12-21WarningsExact identifier
unii: WQZ3G9PF0H
GUNA-ORALACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -Guna spaf1b8e5ab-8689-4bf2-a6d9-863d02f295792018-12-21WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
GUNA-PMSARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -Guna spa86f341b1-a8f7-4833-a1be-e51610b05bcd2018-12-21WarningsExact identifier
unii: G0R4UBI2ZZ
Fever CPACONITUM NAPELLUS, BRYONIA ALBA, CALCAREA CARBONICA, FERRUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA, PYROGENIUM, SULPHURNatural Creations, Incae23ff31-b23b-469c-9960-6613df7692262018-12-21WarningsExact identifier
unii: U0NQ8555JD
Nausea CPAETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc2746cde1-577b-41d6-9f22-93d8f1a2c2352018-12-21WarningsExact identifier
unii: G0R4UBI2ZZ
Nasal DecongestantCAMELLIA SINENSIS, EPHEDRA VULGARIS, BELLADONNA, ARSENICUM ALBUM, CINNABARIS, KALI BICHROMICUM, PULSATILLA, SEPIA, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, SULPHURNatural Creations, Inc938a25f8-e854-4537-a04d-5e2276199f5c2018-12-21WarningsExact identifier
unii: WQZ3G9PF0H
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDENovel Laboratories, Inc.ce4d4d39-8551-4789-8347-af763635922c2018-11-28Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Harris Teeter Spring Fresh Body WashBENZALKONIUM CHLORIDEHarris Teeter401106d1-a701-48bf-b8fc-1bc0454c41392018-07-26WarningsExact identifier
unii: F5UM2KM3W7
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: F5UM2KM3W7
unii: WQZ3G9PF0H
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCdded25a9-3df4-463a-8685-d2bc03ea4edb2018-07-16Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bacteria ChordAZADIRACHTA INDICA, BELLADONNA, BERBERIS VULGARIS, BOLDO, CANDIDA ALBICANS, CEANOTHUS AMERICANUS, CETRARIA ISLANDICA, CROTALUS HORRIDUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, HYPERICUM PERFORATUM, LAPPA MAJOR, LEDUM PALUSTRE, MILLEFOLIUM, MORBILLINUM, MYRRHA, PANCREAS SUIS, PERTUSSINUM, PHOSPHORUS, PLANTAGO MAJOR, PYROGENIUM, SOLIDAGO VIRGAUREA, ZINGIBER OFFICINALEEnergetix Corpf12539de-a737-437e-9392-727208275ba12018-07-11WarningsExact identifier
unii: W2469WNO6U
unii: WQZ3G9PF0H
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: WQZ3G9PF0H
EAR CARE EARACHE DROPSATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFURRite Aid Corporation58f1f79f-f1dd-3094-e053-2991aa0ac5912018-03-16WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Soft Care SentryBENZALKONIUM CHLORIDEDiversey, Inc.f0686b7b-2f41-4656-8eb2-09483571a1bc2018-03-01WarningsExact identifier
unii: F5UM2KM3W7
Refresh Sanitizing Towlette Organic Grapefruit SplashBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC50843247-c769-410e-930f-4a281a499c302018-01-29WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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