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 97 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unileverb9f65122-4037-de0b-e053-2995a90ae5102024-08-16WarningsExact identifier
unii: F5UM2KM3W7
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLC1373321f-533a-4ab4-8bcd-8bde15371a092024-08-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
V HPARSENICUM ALBUM, BELLADONNA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOXEnergique, Inc.5a46f246-73cb-45d0-8a66-4884879323ce2024-08-13WarningsExact identifier
unii: WQZ3G9PF0H
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack7427c29e-55c1-4c30-b091-058c8bec592f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SleepCalm KidsMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironaef7b774-355a-3fb8-e053-2a95a90a268c2024-08-09Exact identifier
unii: G0R4UBI2ZZ
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf1791d4f-029a-487f-aee1-fc5be246d0bc2024-08-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
unii: F5UM2KM3W7
Proclean Foaming Antibacterial NexaBENZALKONIUM CHLORIDEEcolab Inc.8c0d8188-67ee-4b2c-9975-4df4511070ee2024-08-06WarningsExact identifier
unii: F5UM2KM3W7
Sleep AssistCHAMOMILLA, COFFEA CRUDA, AVENA SATIVA, NUX VOMICA, PASSIFLORA INCARNATAThe Magni Companya7e428d3-9460-48d0-9c8d-1e8846bec8572024-08-06WarningsExact identifier
unii: G0R4UBI2ZZ
EcoCare 280BENZALKONIUM CHLORIDEEcolab Inc.89e45f4c-7599-4070-9f7c-07c7286e3c6f2024-08-06WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.63a5dd9f-9354-4d8b-a75c-d30f65ca19d72024-08-05WarningsExact identifier
unii: F5UM2KM3W7
Lung LiquescenceEUCALYPTUS GLOBULUS, LUNG (BOVINE), SANGUINARIA CANADENSIS, ADRENALINUM, BELLADONNANutritional Specialties, Inc.90fa56f2-23ba-412b-884c-d0e44f9bf8a02024-08-05WarningsExact identifier
unii: WQZ3G9PF0H
PROCLEANBENZALKONIUM CHLORIDEEcolab Inc.60da90e4-3467-4aea-9c44-09a9ef7189952024-08-05WarningsExact identifier
unii: F5UM2KM3W7
SwisherBENZALKONIUM CHLORIDEEcolab Inc.29cb072c-5273-4121-9288-2228335590e52024-08-05WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.acdce645-5a74-4a45-aa7b-6f08bc8c89af2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
SwisherBENZALKONIUM CHLORIDEEcolab Inc.04e2f617-0643-4097-8780-b64c58c5b56c2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.14ba88a3-af32-4191-afed-cdcc7eb8ad6a2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.02d45eff-398a-44fe-bd56-5257cf596e7d2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
Burn AideCALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, KALI BICHROMICUM, PICRICUM ACIDUM, URTICA URENSEnergique, Inc.62ce13b1-ca8d-4d6b-932d-db13a816bc372024-08-05WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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