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 45 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
StellaLife VEGA Oral Care RinseRINSEStellaLife, Inc.46f3b20e-1ed9-0d1e-e054-00144ff88e882025-01-08WarningsExact identifier
unii: W2469WNO6U
Plantain Spruce CoughPLANTAIN SPRUCE COUGHUriel Pharmacy Inc.d6a99616-4a08-0909-e053-2995a90a0d2f2025-01-07WarningsExact identifier
unii: WQZ3G9PF0H
Lachesis BelladonnaLACHESIS BELLADONNAUriel Pharmacy Inc.c617a849-5043-43cd-974f-2f0d664fd4682025-01-07WarningsExact identifier
unii: WQZ3G9PF0H
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: WQZ3G9PF0H
Cardioforce IARNICA MONTANA, CACTUS GRANDIFLORUS, CAPSICUM ANNUUM, DIGITALIS PURPUREA, KALI PHOSPHORICUM, LAUROCERASUS, SPIGELIA ANTHELMIA, TABACUM, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, AURUM MURIATICUM, GLONOINUM, IGNATIA AMARA, KALMIA LATIFOLIA, LATRODECTUS MACTANS, VALERIANA OFFICINALISBioActive Nutritional, Inc.506c0d88-d888-4f7a-b8de-cb00482c25372025-01-02WarningsExact identifier
unii: U0NQ8555JD
Behavior-RiteANACARD, CHAMOMILLA, CINA, THEA SINENSIS, VIOLA TRICSilver Star Brandsb78dbf3f-33fc-8613-e053-2a95a90ac7c22025-01-01WarningsExact identifier
unii: G0R4UBI2ZZ
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: W2469WNO6U
NativeRemedies Kidney Stone ClearBELLADONNA,BERBERIS VULGARIS, CALC CARB, CANTHARIS, LYCOPODIUMSilver Star Brandsf669d03b-52af-7f1b-e053-2a95a90a75c52025-01-01WarningsExact identifier
unii: WQZ3G9PF0H
Mucus-Clear Jr. NighttimeCHAMOMILLA, CINA, KALI BIC, KALI CARB, KALI MUR, PULSATILLASilver Star Brands830e4796-5371-f681-e053-2991aa0a8e832025-01-01WarningsExact identifier
unii: 660YQ98I10
unii: G0R4UBI2ZZ
NativeRemedies Sciatigon MACONITUM NAPELLUS, BERBERIS VULGARIS, CHAMOMILLA, COLOCYNTHIS, MAGNESIA PHOSPHORICA, RHUS TOX.Silver Star Brandsf69389b6-fbcb-49f0-e053-2a95a90a655f2025-01-01WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
NativeRemedies Tic TamerCHAMOMILLA, CINA, HYOSCYAMUS, ZINC METSilver Star Brandsf76c2b90-d5fa-e765-e053-6394a90af57f2025-01-01WarningsExact identifier
unii: G0R4UBI2ZZ
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 660YQ98I10
Mucus-Clear NighttimeHEPAR SULPH, KALI BIC, KALI CARB, KALI MUR, NUX VOMSilver Star Brands826c01f3-a8b6-48c7-e053-2a91aa0a3ce12025-01-01WarningsExact identifier
unii: 660YQ98I10
Mucus Clear Cough and Cold ReliefARG MET, ARSENICUM ALB, BAPTISIA, BRYPNIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, KALI MUR, MERC CORROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VAL.Silver Star Brandsf4378d84-73d5-2170-e053-2a95a90a41c62025-01-01WarningsExact identifier
unii: 660YQ98I10
Mucus-Clear Sinus ReliefBELLADONNA, HEPAR SULPH CALC, KALI BIC, PULSATILLA, SANGUINARIA, SPIGELIA ANTHSilver Star Brandsc4459a80-3de7-504a-e053-2a95a90a337a2025-01-01WarningsExact identifier
unii: WQZ3G9PF0H
Mucus-ClearKALI BIC, KALI MUR, KALI SULPHSilver Star Brandsc895c490-7ca1-dee6-e053-2995a90a21262025-01-01WarningsExact identifier
unii: 660YQ98I10
Migraine EaseBELLADONNA, BRYONIA, CIMICIFUGA, GELSEMIUM, GLONOINUM, IGNATIA, IRIS VERS, NUX VOM, SANGUINARIA, SEPIA, SPIGELIA ANTHSilver Star Brandsc68ab321-7105-0e54-e053-2995a90a298a2025-01-01WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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