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 67 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 387BENZALKONIUM CHLORIDEWhisk Products, Inc.8fa2a6c1-f9f3-4895-861e-82d4d68e54c42025-05-22WarningsExact identifier
unii: F5UM2KM3W7
BIOPURE20CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.359f43c7-682a-ba1c-e063-6394a90a8dcb2025-05-21WarningsExact identifier
unii: F5UM2KM3W7
Immu-n WakerAPIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUMNewton Laboratories, Inc.35a8381a-7fed-ab93-e063-6394a90ae3d72025-05-21WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Immu-n WakerAPIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUMNewton Laboratories, Inc.35a9e9f4-0cfa-a444-e063-6294a90ae6a52025-05-21WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Aconitum Napellus 30XACONITUM NAPELLUSLaboratoire Schmidt-Nagel Inc.32fd6811-9ec9-7787-e063-6294a90aed2d2025-05-20WarningsExact identifier
unii: U0NQ8555JD
Belladonna 30XBELLADONNALaboratoire Schmidt-Nagel Inc.33628150-4483-e973-e063-6294a90a05d82025-05-20WarningsExact identifier
unii: WQZ3G9PF0H
Chamomilla 30XCHAMOMILLALaboratoire Schmidt-Nagel Inc.3362a2d9-9bbd-0490-e063-6294a90a30792025-05-20WarningsExact identifier
unii: G0R4UBI2ZZ
Walgreens Advanced Wound WashBENZALKONIUM CHLORIDEWalgreens Co.25c6d81c-d462-5a89-e063-6294a90a08f32025-05-20WarningsExact identifier
unii: F5UM2KM3W7
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.ddfad5cd-c928-42c0-9562-9feebb73a2cb2025-05-19WarningsExact identifier
unii: WQZ3G9PF0H
VLITEPRO BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.3543d2f6-16d3-aa65-e063-6294a90a96372025-05-19WarningsExact identifier
unii: F5UM2KM3W7
bolor sanitizing hand wipesBOLOR SANITIZING HAND WIPESGuangzhou Baihua Co., Ltd34cdd54b-44e2-c1fd-e063-6294a90a29672025-05-19WarningsExact identifier
unii: F5UM2KM3W7
Throat FormulaBAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.6218a61a-4b5a-4ed2-bb8b-301dd898739e2025-05-19WarningsExact identifier
unii: WQZ3G9PF0H
WhiskCare 357BENZALKONIUM CHLORIDEWhisk Products, Inc.6d423304-de27-402c-9b18-99ab22b457e02025-05-16WarningsExact identifier
unii: F5UM2KM3W7
Lymph IECHINACEA (ANGUSTIFOLIA), KALI IODATUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, HYPOPHYSIS SUIS, APIS MELLIFICA, ARANEA DIADEMA, BELLADONNA, CALCAREA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, GALIUM APARINE, GRAPHITES, LACHESIS MUTUS, MERCURIUS PRAECIPITATUS RUBER, MYRISTICA SEBIFERA, PHOSPHORUS, RHUS TOX, SCROPHULARIA NODOSA, SULPHUR, THYROIDINUM (SUIS), VESPA CRABROBioActive Nutritional, Inc.d3499253-ef69-4c95-ab96-2399b7a13de52025-05-16WarningsExact identifier
unii: WQZ3G9PF0H
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: WQZ3G9PF0H
BELLADONNA 30C - 3-PackBELLADONNASEVENE USA31e1ac26-e613-5631-e063-6394a90a579c2025-05-15WarningsExact identifier
unii: WQZ3G9PF0H
CHAMOMILLA 30C - 3-PackCHAMOMILLASEVENE USA31e1cdc7-b32f-d36c-e063-6294a90a27c02025-05-15WarningsExact identifier
unii: G0R4UBI2ZZ
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
WhiskCare 357BENZALKONIUM CHLORIDEWhisk Products, Inc.2f23296e-8520-b2e2-e063-6294a90a3e9e2025-05-14WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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