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 57 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Xpect Antiseptic WipesANTISEPTIC CLEANSERCintas Corporation8f1fd933-965e-42ec-ab96-47cfe780f9632025-09-29WarningsExact identifier
unii: F5UM2KM3W7
ProHeal BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.3ffc3f34-086d-1d18-e063-6294a90a71bb2025-09-29WarningsExact identifier
unii: F5UM2KM3W7
First Aid Direct Antiseptic WipeBENZALKONIUM CHLORIDECintas Corporationa23f3685-7213-4cc0-97b2-588fb12247922025-09-29WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntispeticBENZALKONIUM CHLORIDEUnishieldf72851ba-bbdd-5533-e053-6294a90a82162025-09-28WarningsExact identifier
unii: F5UM2KM3W7
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEAocai Biotechnology Huizhou Co Ltd3fa738ce-0a04-fa11-e063-6294a90aba882025-09-25WarningsExact identifier
unii: F5UM2KM3W7
EZ-448 Antibacterial Moist HandBENZALKONIUM CHLORIDEEz Products Of South Florida, LLC664ab52d-60e3-a8c8-e053-2a91aa0a7c402025-09-24WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEEpic Pharma, LLC00615fad-ad3b-46e8-a89d-48290d937ae22025-09-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Panic EaseACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9971a152-0706-8166-e053-2995a90aab9f2025-09-23WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Potassium ChloridePOTASSIUM CHLORIDEMacleods Pharmaceuticals Limited89d827c8-91af-4bfd-a846-62e55824e9832025-09-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticalsa9d68a40-75e3-4c5c-b5d7-1d6160527fa72025-09-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Xpect AntisepticBENZALKONIUM CHLORIDECintas Corporationd9a31a11-e80f-4ded-ad0a-34f93b01557e2025-09-22WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.3f2b75d8-89f1-8d67-e063-6294a90a01662025-09-19WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
I-SleepABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANANewton Laboratories, Inc.c6f053fe-8b59-7226-e053-2995a90a80932025-09-18WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
MOONIES Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEHangzhou Chunchi Touring Commodity Co., Ltd.3eee1a5c-e926-5251-e063-6294a90a5d2e2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
MyTerra Hand Sanitizer Foam NABENZALKONIUM CHLORIDEPortionPac Chemical Corporation207ed8a6-b8db-43c9-9335-b313b16af9d52025-09-17WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEGertex Hosierya182eafa-0ce0-4b99-bcb0-23f9a8de9e1f2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC190d7d61-5ea9-6670-e063-6294a90a45352025-09-17WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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