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 17 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: G0R4UBI2ZZ
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Tiny Tot Cough SyrupSQUILLA, ANTIMONIUM TART, ARSENICUM ALB, BELLADONNA, BRYONIA, CHAMOMILLA, CUPRUM MET, DROSERA, HEPAR SULPH CALC, IPECACUANHA, KALI BIC, KALI CARB, PHOSPHORUS, PULSATILLA, SPONGIANatural Creations, Inc38cc6bfc-c59f-4df1-9cff-10b3673b475a2025-12-18WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
VIRAL HPARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.95902493-0881-4a72-be53-2916648627cd2025-12-18WarningsExact identifier
unii: WQZ3G9PF0H
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC0700c19e-abca-4527-8944-e4440a32e3af2025-12-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ThroatBAPTISIA, PHYTOLACCA, HYDRASTIS, APIS MEL, ARG NIT, BELLADONNA, HEPAR SULPH CALC, KALI BIC, LAC CAN, LACHESIS, MERC SOLUBNatural Creations, Incd393ac56-cc87-433e-87ea-5a5de7fd0d282025-12-18WarningsExact identifier
unii: WQZ3G9PF0H
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: WQZ3G9PF0H
SleepEaseAQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC METEight & Company L.L.C9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e62025-12-18WarningsExact identifier
unii: G0R4UBI2ZZ
VIROSODEECHINACEA ANGUSTIFOLIA, HYDRASTIS CANADENSIS, LOMATIUM, PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CARCINOSIN, COXSACKIE, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, HERPES ZOSTER, INFLUENZINUM, MORBILLINUM, PERTUSSIN, PYROGENIUMNatural Creations, Inc80b40e26-ce13-4027-bebc-c4bd6014e3ad2025-12-18WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bacteria-ChordAZADIRACHTA, BELLADONNA, BERBER VULG, BOLDO, CANDIDA ALB, CEANOTHUS, CETRARIA, CROTALUS HOR , ECHINACEA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA, HAMAMELIS, HEPAR SUIS, HYDRASTIS, HYDROCOTYLE, HYPERICUM, LAPPA, LEDUM, MILLEFOLIUM, MORBILLINUM, MYRRHA, PANCREAS, PERTUSSINUM, PHOS, PLANTAGO, PYROGENIUM, SOLIDAGO, ZINGIBEREnergetix Corporation78c680c9-70bf-4df3-8a82-802f203c3da42025-12-17WarningsExact identifier
unii: W2469WNO6U
unii: WQZ3G9PF0H
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Pediatric Earache RemedyEAR DROPSVitality Works, Inc5769ce2c-d2e1-4069-92cc-e38bee668daf2025-12-17WarningsExact identifier
ndc (package): 64616-050-02
ndc (package): 64616-050-01
ndc (product): 64616-050
ndc11 (package): 64616005001
spl id: 462ed52e-9da2-6cc3-e063-6294a90ad318
spl set id: 5769ce2c-d2e1-4069-92cc-e38bee668daf
unii: C9TD27U172
unii: W2469WNO6U
unii: 660YQ98I10
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
TLB-MatrixJOINT BOOSTERVitality Works, Inc.828aa3c0-b7f4-4169-92f1-6ef5f358e18a2025-12-17WarningsExact identifier
unii: WQZ3G9PF0H
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: W2469WNO6U
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 660YQ98I10
Cal-5-ReviveCALCIUM BALANCEVitality Works, Inc.a642c238-dacc-41a0-8590-ca466eb297892025-12-17WarningsExact identifier
unii: U0NQ8555JD
CL-NEMOTIONAL HEALTH BOOSTERVitality Works, Inc.0de1e383-f721-4d2c-a1e1-946371234b882025-12-17WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
unii: C9TD27U172
unii: W2469WNO6U
unii: 660YQ98I10
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Gripe WaterGRIPE WATERVitality Works45ade734-f446-4370-e054-00144ff88e882025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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