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 56 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOCKE TEDDY Foaming Hand SanitizerBENZALKONIUM CHLORIDEKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD72bb2762-41c9-4213-9a76-4c3e9b3583832025-10-07WarningsExact identifier
unii: F5UM2KM3W7
Sick StopperECHINACEA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ARALIA QUINQUEFOLIA, BAPTISIA TINCTORIA, BRYONIA, CHELIDONIUM MAJUS, EUPATORIUM PERFOLIATUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS, SULPHUR, THUJA OCCIDENTALIS, BUFO RANA, NUX VOMICA, ANTHRACINUM, INFLUENZINUM, PYROGENIUMNewton Laboratories, Inc.016b7532-8cb6-df55-e063-6394a90abd752025-10-06WarningsExact identifier
unii: U0NQ8555JD
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC33e1e96d-1058-35d5-e063-6394a90a4c9e2025-10-06WarningsExact identifier
unii: F5UM2KM3W7
InfluensegGALPHIMIA GLAUCA, CAUSTICUM, EUPATORIUM PERFOLIATUM, IPECACUANHA, ACONITUM NAPELLUS, KALI BICHROMICUM, AVENA SATIVA, INFLUENZINUM (2021-2022), LOBELIA PURPURESCENS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ECHINACEA (ANGUSTIFOLIA), CANCHALAGUANucleic Products, LLC48a07004-5b52-4be6-ac88-55725da069312025-10-06WarningsExact identifier
unii: U0NQ8555JD
PyostatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ARSENICUM ALBUM, BELLADONNA, CROTALUS HORRIDUS, HYOSCYAMUS NIGER, LACHESIS MUTUS, PYROGENIUM, TARENTULA CUBENSIS, ANTHRACINUMEnergique, Inc.427417ce-72a8-4d46-be24-b8b0fdc854582025-10-06WarningsExact identifier
unii: WQZ3G9PF0H
TopricinAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFURTopical BioMedics, Inc.321e83de-71e8-20b4-e054-00144ff8d46c2025-10-03WarningsExact identifier
unii: WQZ3G9PF0H
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.cc15ef60-6956-4d34-b86d-72cdd0c0c0bb2025-10-02Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Equate Antibacterial Fresh Hand WipesBENZALKONIUM CHLORIDEWalmart, Inc.d2bc26d8-3e46-e479-e053-2995a90abc0a2025-10-01WarningsExact identifier
unii: F5UM2KM3W7
Equate Antibacterial Wipes FreshBENZALKONIUM CHLORIDEWalmart, Inc.21d86d5b-46ee-6ffd-e063-6394a90ab0e52025-10-01WarningsExact identifier
unii: F5UM2KM3W7
Equate Antibacterial Wipes CitrusBENZALKONIUM CHLORIDEWalmart, Inc.2450dc1b-0c89-c92a-e063-6394a90afe222025-10-01WarningsExact identifier
unii: F5UM2KM3W7
Equate Antibacterial Citrus Hand WipesBENZALKONIUM CHLORIDEWalmart, Inc.d2cb4c64-66fc-58e4-e053-2a95a90a7f662025-10-01WarningsExact identifier
unii: F5UM2KM3W7
Kroger Antibacterial Hand WipesBENZALKONIUM CHLORIDEThe Kroger Co.17e29138-8c1f-e3b1-e063-6294a90a5d482025-10-01WarningsExact identifier
unii: F5UM2KM3W7
TopricinAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA, LACHESIS MUTUS, NAJA TRIPUDIANS, RHUS TOXICODENDRON, RUTA GRAVEOLENSTopical BioMedics, Inc.53f5778f-ab62-4dda-9bd9-8cc7fdd69d1e2025-10-01WarningsExact identifier
unii: WQZ3G9PF0H
Boogie Hands Antibacterial Wet WipesBENZALKONIUM CHLORIDE (0.115%)ELEEO BRANDS LLC815ca8f9-f0bf-44df-8b90-1c9a40d46d1d2025-09-30WarningsExact identifier
unii: F5UM2KM3W7
Boogie Hands Antibacterial Wet WipesBENZALKONIUM CHLORIDE (0.13%)ELEEO BRANDS LLC4009eb93-cef6-a202-e063-6394a90ae61b2025-09-30WarningsExact identifier
unii: F5UM2KM3W7
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ee484505-3bb1-2989-e053-2995a90aea2b2025-09-30WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules Pharmaceuticals Inc.b3d4d5b5-2898-ae3d-e053-2a95a90a6d042025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEGranules Pharmaceuticals Incc1f4832d-4d5c-8c49-e053-2a95a90ac9fe2025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack0e875691-7372-46ac-80a1-946e08b400612025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Xpect First Aid CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLCintas Corporationf7112e5d-c8c4-42ad-8a65-24bfc32d4aea2025-09-30WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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