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 108 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAdare Pharmaceuticals Inc22edb0e6-4e45-4e91-aead-3581cca293a02023-12-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lite n Foamy Non-Alcohol Hand SanitizerLITE N FOAMY NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8be683-f935-b32b-e053-2995a90aa51f2023-12-19WarningsExact identifier
unii: F5UM2KM3W7
Lite nFoamy E3 Hand SanitizerBENZALKONIUM CHLORIDESpartan Chemical Company2754e9bf-8c81-45b6-b243-993b9c4f99562023-12-19WarningsExact identifier
unii: F5UM2KM3W7
PainACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CARTILAGO SUIS, CAUSTICUM, CHAMOMILLA, COFFEA CRUDA, EUPHORBIUM OFFICINARUM, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PASSIFLORA INCARNATA, PYROGENIUM, RANUNCULUS BULBOSUS, SYMPHYTUM OFFICINALELiddell Laboratories, Inc.b591e679-b481-47f1-8d4e-3f3040e9a42a2023-12-19WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
BelladonnaBELLADONNAEnergique, Inc.1464f849-240b-415d-85db-50b21ff9f38b2023-12-19WarningsExact identifier
unii: WQZ3G9PF0H
Tincture MerthiolateBENZALKONIUM CHLORIDEDLC Laboratories, Inc4fec9119-fbbf-4fc7-9122-c6300cac87312023-12-18WarningsExact identifier
unii: F5UM2KM3W7
HUMCO MerthiolateBENZALKONIUM CHLORIDEHumco Holding Group, Inc.864063a5-c6cc-4657-9cd6-51af4673bf982023-12-15WarningsExact identifier
unii: F5UM2KM3W7
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
unii: F5UM2KM3W7
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5aa0adf8-7b84-4cb0-be31-5c3333a6cc442023-12-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5c4b0be5-625e-435f-9d2c-9d8fb407a8ea2023-12-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionsd033c3b3-3ed6-4f23-a555-bae40cf0c48f2023-12-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
AngerACONITUM NAPELLUS, ASAFOETIDA, CHAMOMILLA, CROCUS SATIVUS, HYOSCYAMUS NIGER, IGNATIA AMARA, STAPHYSAGRIA, VALERIANA OFFICINALISLiddell Laboratoriesa427f6fe-606f-4248-8f9d-60aa4ba4765b2023-12-01WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Back and Leg HPACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, COLOCYNTHIS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PLUMBUM METALLICUM, RHUS TOX, ARNICA MONTANAEnergique, Inc.45f8cdd2-d518-453a-8aa4-a0cb6b4e6eb02023-11-30WarningsExact identifier
unii: U0NQ8555JD
Antibacterial WipesBENZALKONIUM CHLORIDESHAOXING ELITE BIO-TECH CO.,LTD.b41a4e86-38ec-4e6b-e053-2a95a90aabe82023-11-22WarningsExact identifier
unii: F5UM2KM3W7
Inofoam Antibacterial Foaming Hand WashBENZALKONIUM CHLORIDEAvro Enterprises, LLC4fc1e57f-b909-4dde-8c1a-2793af6eafb02023-11-17WarningsExact identifier
unii: F5UM2KM3W7
Inofoam Antibacterial Foaming Hand WashBENZALKONIUM CHLORIDEAvro Enterprises, LLC6615a17f-4e0a-405d-b60c-da50267d17db2023-11-17WarningsExact identifier
unii: F5UM2KM3W7
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.b501f7bc-fa3a-494e-bf95-6779a3169a492023-11-17WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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