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 34 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM (2021-2022), LACHESIS MUTUS, RHUS TOX, PYROGENIUMEnergique, Inc.9ec6f663-5f15-4daf-a36b-49fbe1c53a6c2025-03-11WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Belladonna 30XATROPA BELLADONNATrue Botanica, LLC2527e4ba-e2a4-23ca-e063-6394a90a24232025-03-10WarningsExact identifier
unii: WQZ3G9PF0H
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BIO9FERR PHOS, KALI MUR, KALI PHOS, MAG PHOSBestmade Natural Products2ffe4c1a-7c14-d3d1-e063-6294a90a03792025-03-10WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BIO10CALC PHOS, FERR PHOS, KALI MURBestmade Natural Products2ffe8e7e-3587-f48a-e063-6394a90aabfa2025-03-10WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 660YQ98I10
Terramed Just Think Comfort leg crampACONITUM NAPELLUS,ARNICA MONTANA,MAGNESIUM PHOSPHORICA,RHUS TOXICODENDRON,VISCUM ALBUMRida LLC741d5ade-cd99-44fa-99fe-02b61655ca632025-03-10WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Restlessness and ImpulsivenessGINKGO BILOBA, SCUTTELLARIA LATERIFOLIA, MATRICARIA RECUTITA, CENTELLA-ASIATICA, AVENA SATIVA, URTICA URENS, ASPALATHUS LINEARISBestmade Natural Products2fc1a565-6b85-5a13-e063-6394a90ac1752025-03-07WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products Natural Sleep Aid and SupplementMATRICARIA RECUTITA, PASSIFLORA INCARNATA, COFFEA, CINABestmade Natural Products2fc27ece-b68b-a9d3-e063-6394a90a39492025-03-07WarningsExact identifier
unii: G0R4UBI2ZZ
SleepCalmMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironde0b458d-5f0a-78f4-e053-2995a90afe4b2025-03-07Exact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 660YQ98I10
BART PLUSACONITUM NAPELLUS, APIS MELLIFICA, ARBUTUS ANDRACHNE, ARNICA MONTANA, ARSENICUM ALBUM, COCCULUS INDICUS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, GUNPOWDER, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALMIA LATIFOLIA, LAC CANINUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, STRAMONIUM, TELLURIUM METALLICUM, THYROIDINUM (SUIS), VERATRUM ALBUMDeseret Biologicals, Inc.4de3d6d4-108c-41b9-8aa7-4225ce494d782025-03-04WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products BM233ACONITE, BELLADONNA, DROSERA, IPECAC, MEPHITIS, THYMUS, VERAT ALBBestmade Natural Products2f820355-5c54-3549-e063-6394a90a147e2025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bestmade Natural Products BM234ACONITE, ARS. ALB, BELLADONNA, BRYONIA, EUP. PERF, GELSEMIUM, PYROGENUMBestmade Natural Products2f825212-ff1f-6037-e063-6394a90a0fca2025-03-04WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products BM236ARG. MET, ARNICA MONT, BRYONIA, CHAMOMILLA, RANUNCULUS BULB, RHUS TOX, RUTA GRAVBestmade Natural Products2f82b461-7059-eacf-e063-6294a90a2ca92025-03-04WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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