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 107 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MenotoneANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, BELLADONNA, LACHESIS MUTUS, PULSATILLA (PRATENSIS), SABINA, SANGUINARIA CANADENSIS, SEPIA, SULPHUREnergique, Inc.0921be57-44b4-4d1c-a50a-7886fc807d002024-01-23WarningsExact identifier
unii: WQZ3G9PF0H
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packaginga67f5ba7-ac23-4bdc-9563-cb7fd049a9512024-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
unii: F5UM2KM3W7
Cold Sore Treatment, 24-7 Life by 7-ElevenBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.0f4fb868-1462-f88e-e063-6394a90a69e42024-01-19WarningsExact identifier
unii: F5UM2KM3W7
ACONITUM NAPELLUS 200ckACONITUM NAPELLUSSEVENE USAc89907e7-fa1c-9b1e-e053-2a95a90aac622024-01-18WarningsExact identifier
unii: U0NQ8555JD
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
unii: F5UM2KM3W7
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: G0R4UBI2ZZ
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationbd46efc8-0b36-0931-e053-2a95a90adb6f2024-01-17WarningsExact identifier
unii: F5UM2KM3W7
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationbc914c36-e0f0-18c5-e053-2a95a90a894e2024-01-17WarningsExact identifier
unii: F5UM2KM3W7
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntispeticBENZALKONIUM CHLORIDEOrazen Incea2debcb-892c-339f-e053-2a95a90a4b182024-01-15WarningsExact identifier
unii: F5UM2KM3W7
Ever Ready First AidBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aide53f3bf5-25c0-2b86-e053-2a95a90a010f2024-01-15WarningsExact identifier
unii: F5UM2KM3W7
FIRST SHIELD First Aid AntisepticBENZALKONIUM CHLORIDEEver Ready First Aide013ef0a-ef3d-7af5-e053-2a95a90a54d32024-01-15WarningsExact identifier
unii: F5UM2KM3W7
Natural Relief Patch for MOTION SICKNESSCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLC161ed609-6029-4e2e-a480-5b4c72defa7b2024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
GoPatch Motion Sickness and Dizziness ReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc4730e15-20e0-37fa-e053-2a95a90a61812024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
AnxiousReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc3cebdf1-66b6-40ea-e053-2995a90ab4ca2024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
Natural Relief Patch for MENSTRUAL CRAMPSBELLADONNA, CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, MAGNESIA PHOSPHORICA, NUX VOMICA, PULSATILLA.Centered Enterprises, LLC82162b47-b614-459f-8129-3fdece8853f62024-01-15WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
GoPatch TummyReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc47320b5-75c2-36ef-e053-2995a90ad7932024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
GoPatch HangoverReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc45fb9bb-e266-6b4f-e053-2995a90a972f2024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
Lung DrainageKALI MURIATICUM, CARBO VEGETABILIS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, PNEUMOCOCCINUM, OXYGENIUM, ANTIMONIUM ARSENICICUM, CAMPHORA, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, IPECACUANHA, LOBELIA PURPURESCENS, PHOSPHORUS, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.8fdb37fb-f3df-4dae-abb4-1f3a71c1c6832024-01-15WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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