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 16 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Bio Biological DetoxECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PROPOLIS, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, THYMUS SERPYLLUM, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYROIDINUM (SUIS), BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, PYROGENIUM, ANTHRACINUM, ARSENICUM, CARBOLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, LACHESIS, VARIOLINUM, BOTULINUM, DYSENTERY BACILLUS, GAERTNER BACILLUS, FRANCISELLA TULARENSIS, COXIELLA BURNETII, LAC CANINUM, MALARIA OFFICINALIS,BioActive Nutritional, Inc.9a6671bb-b070-4f97-bdc0-189cf60407ee2025-12-30WarningsExact identifier
unii: WQZ3G9PF0H
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC471f3a39-5fea-cd7a-e063-6294a90a0d932025-12-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONAjenat Pharmaceuticals LLCc62c5704-3667-4d4f-8230-3f7f5ed825b12025-12-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLC0a72cc27-e092-d85a-e063-6294a90a503c2025-12-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBPI Labs LLCaeb2e14e-cd7c-49d0-a15f-fbbe89a03c6b2025-12-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: G0R4UBI2ZZ
potassium chloridePOTASSIUM CHLORIDERedpharm Drug3735d41a-7787-6b92-e063-6294a90add452025-12-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
StellaLife VEGA Oral Care CoconutRISNEHomeocare Laboratories, Inc.b8c9c924-be3c-b100-e053-2a95a90a3fdc2025-12-24WarningsExact identifier
unii: W2469WNO6U
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: G0R4UBI2ZZ
StellaLife VEGA Oral CareSPRAYHomeocare Laboratories, Inc.46f3ff78-f5fc-6da1-e054-00144ff8d46c2025-12-24WarningsExact identifier
unii: W2469WNO6U
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
StellaLife VEGA Oral Care CoconutRISNEStellaLife, Inc.b8694e38-dc05-77c9-e053-2995a90a36e42025-12-23WarningsExact identifier
unii: W2469WNO6U
Viru-ChordBELLADONNA, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HEPAR SUIS, HYDRASTIS CANADENSIS, ILLICIUM ANISATUM, INFLUENZINUM, LACHESIS MUTUS, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MORBILLINUM, MYRRHA, NASTURTIUM AQUATICUM, NUX VOMICA, PALOONDO, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SAMBUCUS NIGRA, SCUTELLARIA LATERIFLORA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE)Energetix Corporation4a53b25e-f514-4d2d-8c2b-3c56d68ec7eb2025-12-22WarningsExact identifier
unii: WQZ3G9PF0H
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: G0R4UBI2ZZ
StellaLife VEGA Oral Care Coconut Advanced Healing FormulaAZADIRACHTA INDICA, APIS MELLIFICA, CALENDULA, ECHINACEA PURPUREA, OKOUBAKA AUBREVILLEI, PHOSPHOROUS, PLANTAGO MAJOR, STRONTIUM, THUJA OCCIDENTALISStellaLife, Inc.10f6cd02-f80d-f597-e063-6294a90a09aa2025-12-22WarningsExact identifier
unii: W2469WNO6U
StellaLife VEGA Oral Care Peppermint Advanced Healing FormulaAZADIRACHTA INDICA, CALENDULA, ECHINACEA PURPUREA, PLANTAGO MAJORStellaLife, Inc.113ad845-3494-4bd1-e063-6294a90a40ae2025-12-22WarningsExact identifier
unii: W2469WNO6U
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: G0R4UBI2ZZ
StellaLife VEGA Oral Care Cucumber Advanced Healing FormulaAZADIRACHTA INDICA, CALENDULA, ECHINACEA PURPUREA, PLANTAGO MAJORStellaLife, Inc.1139fe05-886f-80d3-e063-6394a90a80e22025-12-22WarningsExact identifier
unii: W2469WNO6U

Reported adverse events (FAERS/openFDA)#

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