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 73 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ER 911ACONITUM NAP, APIS MEL, ARNICA, ARSENICUM ALB, BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, FERRUM PHOS, HISTAMINUM, HYPERICUM, IGNATIA, IMPATIENS GLAN FLOS, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS CERASIFERA, RHUS TOX, SULPHUR, SYMPHYTUM, VERTARUM ALBNet Remedies9daa0b2f-cfca-4a40-ae88-c38c7cd2db322021-01-21WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Visceral PolarityACONITUM NAP, ARG NIT, CHININUM PUR, ECHINACEA PURP, PLUM MET, SEPIA, SULPHURICUM ACNET Remedies971e74ea-f72f-403e-bc79-02901e5019e82021-01-21WarningsExact identifier
unii: U0NQ8555JD
Whole System EEPMERCURIUS CORROSIVUS,NUX VOMICA,HYOSCYAMINUM,CARCINOSINUM,GRAPHITES,ZINCUM METALLICUM,LILIUM TIGRINUM,CINCHONA OFFICINALIS,CAUSTICUM,COFFEA CRUDA,BELLADONNA,IGNATIA AMARA,SCROPHULARIA NODOSA,SPONGIA TOSTA ,CEANOTHUS AMERICANUS,SENNA,HYDRASTIS CANADENSIS,CONDURANGO,CHELIDONIUM MAJUS,PITUITARY GLAND, BOS TAURUS,PANCREAS SUIS,LYCOPODIUM CLAVATUM,BERBERIS VULGARIS,White Manufacturing Inc. DBA Micro-West6fe11fe3-6725-4701-8461-25d4e885a6c42021-01-21WarningsExact identifier
unii: WQZ3G9PF0H
TOTAL PRO-JESADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONEWhite Manufacturing Inc. BDA Micro-Westb26953f8-7b56-432c-958c-d80c528fbb6a2021-01-21WarningsExact identifier
unii: WQZ3G9PF0H
Vermafuge -AG LycopodiumNUX VOMICA,ARSENICUM ALBUM,CINCHONA OFFICINALIS,CAPSICUM ANNUUM,NITRIC ACID,MERCURIUSCORROSIVUS,BELLADONNA,CAJUPUTUM,LYCOPODIUM CLAVATUM,PHOSPHORUS,PHYTOLACCA DECANDRA,RHAMNUS PURSHIANA,FRAGARIA VESCAWhite Manufacturing Inc. DBA Micro-West447c7971-e7ea-4f47-82a2-ed6da883098f2021-01-21WarningsExact identifier
unii: WQZ3G9PF0H
AnxiolixARSENICUM ALBUM ,SCUTELLARIA LATERIFLORA,PHOSPHORUS,LACHESIS MUTUS,PULSATILLA,PASSIFLORA INCARNATA,ACONITE,VALERIANA OFFICINALIS,CALCAREA CARBONICA,IGNATIA AMARAWhite Manufacturing Inc. DBA Micro West69660f20-c9ba-4b43-bc85-0fab3ff68c612021-01-21WarningsExact identifier
unii: U0NQ8555JD
BACTOFLAMECHINACEA,BAPTISIA,APIS MELLIFICA ,FERRUM PHOSPHORICUM ,WHITE MANUFACTURING INC. DBA MICRO WEST3bf75ef6-fc67-4edb-9ed3-204b6af021dd2021-01-21WarningsExact identifier
unii: WQZ3G9PF0H
WoodBELLADONNA, BERBER VULG, CARDUUS MAR, CHELIDONIUM MAJ, CHOLESTERINUM, COLOCYNTHIS, KALI CARB, NAT PHOS, NITRICUM AC, NUX VOM, PLATINUM MET, SEPIANET Remedies95b44ad8-8091-420c-bf18-6e071bd6073b2021-01-19WarningsExact identifier
unii: WQZ3G9PF0H
WaterACONITUM NAP, ARSENICUM ALB, BORAX, CALC PHOS, GELSENIUM, LYCOPODIUM, PHOSPHORICUM AC, PICRICUM AC, PLUMB MET, SOLIDAGONET Remedies3dc6fdf6-781c-4dec-9aab-a2237fc60c532021-01-19WarningsExact identifier
unii: U0NQ8555JD
PAIN RELIEFARNICA, CHAMOMILLA, HYPERICUM, IGNATIA, SYMPHYTUMNET Remedies75786c15-be49-4548-8f7a-319f86aa0cee2021-01-19WarningsExact identifier
unii: G0R4UBI2ZZ
GUNA SLEEP SUPPORTAVENA SATIVA FLOWERING TOP - CAFFEINE - MATRICARIA CHAMOMILLA WHOLE - PASSIFLORA INCARNATA FLOWERING TOP -POTASSIUM BROMIDE - ZINC VALERATE DIHYDRATE - SILVER NITRATE - STRYCHNOS INGATII SEED -Guna spab3ffb7f9-fd2b-5f88-e053-2a95a90aa91c2021-01-17WarningsExact identifier
unii: G0R4UBI2ZZ
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OHM Mucus ReliefANTIMONIUM CRUDUM, ANTIMONIUM TARTARICUM, CHELIDONIUM MAJUS, FERRUM PHOSPHORICUM, KALI CARBOONICUM, KALI MURIATICUM, KALI SULPHURICUM, MARRUBIUM VULGARE.OHM PHARMA INC.f13bff50-7087-46dc-a958-b460a2af62832021-01-11WarningsExact identifier
unii: 660YQ98I10
Real ReliefCHAMOMILA, COFFEA CRUDA, ERIODICTYON CALIFORNICUM, HISTAMINUM, IPECACUANHA, LOBELIA INFLATA, SAMBUCUS NIGRA, SOLIDAGO VIRGAUREAGMP Laboratories of America, Inc.b7a030d9-0644-4778-e053-2995a90a57c72020-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
Poison IvyXEROPHYLLUM ASPHODELOIDES, ACONITUM NAP., ANACARDIUM ORIENTALE, APIS MEL., BRYONIA, CANTHARIS, CROTON, GRAPHITES, GRINDELIA, MEZEREUM, NUX VOM., RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP.,TARAXACUM, URTICA UR.Newton Laboratories, Inc.99e8ca63-4ec3-92a2-e053-2995a90ac9a62020-12-07WarningsExact identifier
unii: U0NQ8555JD
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.997474d5-4dc4-6104-e053-2995a90a03f12020-12-07WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Sciatica-Back CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.99ea75a9-3250-281b-e053-2a95a90aed452020-12-07WarningsExact identifier
unii: U0NQ8555JD
Sinu-SECHINACEA, HYDRASTIS CANADENSIS, ARSENICUM IODATUM, BRYONIA, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, KALI IODATUM, MERCURIUS IODATUS RUBER, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS PULSATILLA, SABADILLA, STICTA , VERBASCUM THAPSUS, SINUSITISINUMNewton Laboratories, Inc.9a667ff9-9438-2cef-e053-2995a90ac0a22020-12-07WarningsExact identifier
unii: C9TD27U172
ViralECHINACEA, HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, GAULTHERIA PROCUMBENS, HEPAR SULPHURIS CALCAREUM, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, TRIFOLIUM PRATENSE, INFLUENZINUM, MORBILLINUM.Newton Laboratories, Inc.9a673e6b-e0d7-77c2-e053-2995a90ac7662020-12-07WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Inflammation-FeverANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEANewton Laboratories, Inc.995c5553-5af7-5a0e-e053-2995a90a6c5c2020-12-04WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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