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 94 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CICLOFERONBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDELaboratorios Liomont, S.A. de C.V.89081ef8-9721-a476-e053-2995a90ae0de2024-10-17WarningsExact identifier
unii: F5UM2KM3W7
Bebesup Antibacterial Handy WipesBENZALKONIUM CHLORIDEAJ Co., Ltd.24b75970-5138-ce50-e063-6394a90a123c2024-10-17WarningsExact identifier
unii: F5UM2KM3W7
Cardioforce IARNICA MONTANA, CACTUS GRANDIFLORUS, CAPSICUM ANNUUM, DIGITALIS PURPUREA, KALI PHOSPHORICUM, LAUROCERASUS, SPIGELIA ANTHELMIA, TABACUM, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, AURUM MURIATICUM, GLONOINUM, IGNATIA AMARA, KALMIA LATIFOLIA, LATRODECTUS MACTANS, VALERIANA OFFICINALISBioActive Nutritional, Inc.0bb404b6-a7c1-4077-995e-d7ce59409a292024-10-17WarningsExact identifier
unii: U0NQ8555JD
Hayfever TonicECHINACEA PURPUREA, HYDRASTIS CANADENSIS, EUPATORIUM PERFOLIATUM, VERBASCUM THAPSUS, AILANTHUS GLANDULOSUS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AURUM MURIATICUM, CAMPHORA, IPECACUANHA, KALI BICHROMICUM, SOLIDAGO VIRGAUREA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, AMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, SILVER BIRCH, OAK, HICKORYBioActive Nutritional, Inc.f4395bb7-c186-4e4f-a7cd-a7f3db46091a2024-10-17WarningsExact identifier
unii: C9TD27U172
Headache TonicCARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.a6526cc4-028b-45df-ac1f-c3cec7556e932024-10-17WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.af08f71c-974e-076b-e053-2995a90afc952024-10-15WarningsExact identifier
unii: F5UM2KM3W7
Genuine First Aid First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.af08c8f7-8761-ee3f-e053-2995a90a96772024-10-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEAcme United Corporationc927f845-1383-ae85-e053-2995a90a12fc2024-10-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only BZK AntisepticBENZALKONIUM CHLORIDEAcme United Corporationdbed7ed6-a9b8-7b59-e053-2a95a90ac0cb2024-10-15WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH BLUEBERRIESBENZALKONIUM CHLORIDEUniversal Distribution Center LLC3a1b0112-a400-4cea-9372-c0654e5182672024-10-15WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH TROPICAL BEACHBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747affab-118b-882d-e053-2a91aa0a25642024-10-15WarningsExact identifier
unii: F5UM2KM3W7
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Target Up and Up 2-in-1 Hand SanitizerBENZETHONIUM CHLORIDETARGET CORPORATIONe069c9e6-024d-5482-e053-2995a90a767d2024-10-14WarningsExact identifier
unii: F5UM2KM3W7
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
First Aid Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Changjian Medical Products Co., Ltd.9cb3759a-35d9-4f6b-94ad-fafd4bc600bd2024-10-11WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic ToweletteBENZALKONIUM CHLORIDEHubei Changjian Medical Products Co., Ltd.bf045881-9636-4000-a0ac-f6aab6b818322024-10-11WarningsExact identifier
unii: F5UM2KM3W7
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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