FDA.reportPublic FDA data

NDC 64616-050-01 - Pediatric 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
64616-050
Requested NDC
64616-050-01
Package NDCs from labels
64616-050-01, 64616-050-02
Manufacturer
Vitality Works, Inc | 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.Vitality Works, Inc | Vitality Works, Inc.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-050-01Pediatric Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID159
64616-050-02Pediatric Earache Remedy1 in 1 CARTONLIQUID19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-050PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]8Current NDC, Legacy NDC, 2 package rows20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1

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 55 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.0fb69003-c66c-97ad-e063-6394a90a4c9b2024-01-24WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Chamomilla 30cMATRICARIA RECUTITASEVENE USAe26bedb2-cd71-4550-b1b3-4f967363d45a2024-01-24WarningsExact identifier
unii: G0R4UBI2ZZ
ACONITUM NAPELLUSACONITUM NAPELLUSSEVENE USA62663741-0b6c-4dce-83ec-bb7ded0596722024-01-23WarningsExact identifier
unii: U0NQ8555JD
BelladonnaATROPA BELLADONNASEVENE USA95cd96af-2537-4d4b-be54-7d1030380b4d2024-01-23WarningsExact identifier
unii: WQZ3G9PF0H
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
ACONITUM NAPELLUS 200ckACONITUM NAPELLUSSEVENE USAc89907e7-fa1c-9b1e-e053-2a95a90aac622024-01-18WarningsExact identifier
unii: U0NQ8555JD
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
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
Belladonna and OpiumATROPA BELLADONNA AND OPIUMBryant Ranch Prepack088b9cd1-da68-4c34-8f09-62c2cde19e1f2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WQZ3G9PF0H
POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.4d90d03d-7f0e-4d49-9e80-628dbc7165c02024-01-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.8ed8ea55-8b15-f718-e053-2a95a90a587a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
E07 TYPE A BALANCEACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, CHININUM ARSENICOSUM, COFFEA CRUDA, COLCHICUM AUTUMNALE, CRATAEGUS OXYACANTHA FRUIT, ECHINACEA PURPUREA, ESCHSCHOLTZIA CALIFORNICA, HUMULUS LUPULUS, IGNATIA AMARA, LYCOPUS VIRGINICUS, NUX VOMICA, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRYCHNINUM PHOSPHORICUM, THYROIDINUM, VISCUM ALBUM FRUITING TOP, YELLOW JASMINE ROOTApex Energetics Inc.06c113f5-63be-f431-e063-6294a90a7d4f2024-01-09WarningsExact identifier
unii: U0NQ8555JD
B20 ACUTE RESCUEACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUSApex Energetics Inc.bccc6476-4987-b1a0-e053-2995a90a5a022024-01-09WarningsExact identifier
unii: C9TD27U172
unii: W2469WNO6U
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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