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 49 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chavita 3ARGENTUM MET, CHAMOMILLA, CHELIDONIUM MAJUS, NUX VOMICA, PANCREAS SUIS, LYCOPODIUM, ZINGIBERRUBIMED AG4895e274-7fa7-4f2f-a536-fa883505ead42024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
SimvitaCEREBRUM, CHAMOMILLA, EPHEDRA VULGARIS, SECALERUBIMED AG82331ea9-bd10-4f06-8c7c-d4ef47d585d62024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack55747ef3-9437-4bdc-9ebd-a74d8e2de1cf2024-10-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Menopause HPBELLADONNA, LACHESIS MUTUS, MANGANUM ACETICUM, NUX VOMICA, PULSATILLA (PRATENSIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDISEnergique, Inc.6412a5f1-5587-4d4e-8d3f-6929794154362024-10-29WarningsExact identifier
unii: WQZ3G9PF0H
Multi-Cell SaltKALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEAEnergique, Inc.dad00225-b3ac-4e36-a856-19b0faf42c422024-10-29WarningsExact identifier
unii: 660YQ98I10
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 660YQ98I10
Numbness HPACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ARNICA MONTANA, COFFEA CRUDA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PHOSPHORUS, PLUMBUM METALLICUMEnergique, Inc.0c4ba547-b4b4-41d0-8a6b-1141ff5f94532024-10-29WarningsExact identifier
unii: U0NQ8555JD
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Nerve Pro HPPLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, COLOCYNTHIS, MAGNESIA PHOSPHORICA, AGARICUS MUSCARIUS, HYPERICUM PERFORATUM, ARGENTUM NITRICUM, CARBONEUM SULPHURATUM, CURARE, THALLIUM METALLICUMEnergique, Inc.846d5805-6f82-4cb4-b64c-adba6d3004e72024-10-29WarningsExact identifier
unii: W2469WNO6U
IndustristatPLANTAGO MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CADMIUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.1279a90c-6263-4ca6-87e1-4b31a36854bb2024-10-28WarningsExact identifier
unii: W2469WNO6U
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bowel - Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.907f582f-c060-cc60-e053-2a95a90a6f222024-10-24WarningsExact identifier
unii: C9TD27U172
unii: G0R4UBI2ZZ
Cold HPACONITUM NAPELLUS, ALLIUM CEPA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS SOLUBILIS, NUX VOMICA, PULSATILLA (VULGARIS)Energique, Inc.d13b3de8-b1bc-41bd-a964-c3d8ba9f29fd2024-10-24WarningsExact identifier
unii: U0NQ8555JD
ElimitoneBELLIS PERENNIS, ECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ARNICA MONTANA, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMEnergique, Inc.bc6352e0-6851-4971-948b-b18da7c1c8b62024-10-24WarningsExact identifier
unii: 660YQ98I10
Cort SymAPIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, MEZEREUM, RHUS TOX, ASTACUS FLUVIATILIS, GELSEMIUM SEMPERVIRENSEnergique, Inc.8e9cd014-d0fa-4e8e-bd02-5b7bf27673ff2024-10-24WarningsExact identifier
unii: WQZ3G9PF0H
Care and Comfort CreamACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALEEnergique, Inc.ac8ee81f-0af4-46d4-b63f-beeb7d120f802024-10-24WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Cognition HPANACARDIUM ORIENTALE, BELLADONNA, HYOSCYAMUS NIGER, KALI BROMATUM, VERATRUM ALBUM, BARYTA CARBONICA, LACHESIS MUTUS, PHOSPHORUS, STRAMONIUMEnergique, Inc.cd56bedf-441b-42af-ad38-def61bf810d82024-10-24WarningsExact identifier
unii: WQZ3G9PF0H
Dental PainACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICADeseret Biologicals, Inc.3a117358-3c51-4870-9932-701ffe90e3f82024-10-23WarningsExact identifier
unii: W2469WNO6U
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Umcka FastActives BerryPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUSSchwabe North America, Inc149941fb-9b5f-42f2-bf0c-e5980f7daad62024-10-23WarningsExact identifier
unii: U0NQ8555JD
Trauma ReliefCHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, MILLEFOLIUM, CALENDULA OFFICINALIS, ARNICA MONTANA, BELLADONNA, BELLIS PERENNIS, CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS, SYMPHYTUM OFFICINALE, RHUS TOX, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, CARBO VEGETABILISDeseret Biologicals, Inc.651f998a-c150-4f38-8582-b9bd971409102024-10-22WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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