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 14 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Echinacea Combination 9222ECHINACEA COMBINATIONProfessional Complementary Health Formulas430cc9f6-5565-4345-ac5f-d948fb3b14bd2026-01-08WarningsExact identifier
unii: U0NQ8555JD
RET Heart 7009RET HEARTProfessional Complementary Health Formulase2bf8331-1c50-4216-93a4-1d3cf64047592026-01-08WarningsExact identifier
unii: U0NQ8555JD
Magnesium Combination 9232MAGNESIUM COMBINATIONProfessional Complementary Health Formulas4d99b3ec-724f-4385-ae5e-83389bb0c8fe2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Food Poisoning Detox 6023FOOD POISONING DETOXProfessional Complementary Health Formulas76eff6d5-a8dc-4b06-91b7-fa0f1657df1a2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Lyme Nosode Drops 2128LYME NOSODE DROPSProfessional Complementary Health Formulasc9fed770-938a-406b-ac95-593d1318ecce2026-01-08WarningsExact identifier
unii: 660YQ98I10
Low Back Pain Drops 2041LOW BACK PAIN DROPSProfessional Complementary Health Formulasc9b3e606-5991-4ce4-9e0d-51bcb44da5832026-01-08WarningsExact identifier
unii: U0NQ8555JD
Sleep Disorder Drops 2152SLEEP DISORDER DROPSProfessional Complementary Health Formulas55af88df-8e5a-4e84-a8f6-fc3063d913812026-01-08WarningsExact identifier
unii: U0NQ8555JD
Sciatica Drops 2059SCIATICA DROPSProfessional Complementary Health Formulasbced3ea7-18fb-41eb-bc41-ac043cf4b02f2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Baryta Combination 9209BARYTA COMBINATIONProfessional Complementary Health Formulascca7da01-b28b-46c3-b025-d0bd12074aa12026-01-08WarningsExact identifier
unii: U0NQ8555JD
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: U0NQ8555JD
Restless Leg Drops 2172RESTLESS LEG DROPSProfessional Complementary Health Formulas73822225-f10c-4d2a-8cd8-ea31dd2b27892026-01-08WarningsExact identifier
unii: U0NQ8555JD
Bryonia Combination 9212BRYONIA COMBINATIONProfessional Complementary Health Formulas36f8599e-8b35-4903-9731-dbcc2fa5092e2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Calendula Combination 9260CALENDULA COMBINATIONProfessional Complementary Health Formulas0e0770d8-680a-471a-b496-7105631ca6f42026-01-08WarningsExact identifier
unii: U0NQ8555JD
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: U0NQ8555JD
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: U0NQ8555JD
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Limiteda9e9d134-55d0-47ae-925f-de07e7ffa4b82026-01-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Ltd.f4497c26-da16-45b0-975d-81f2c21327042026-01-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Potassium ChloridePOTASSIUM CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23b10bd6-11bc-495e-bb05-ec332a9b3f212026-01-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PyostatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ANTHRACINUM, ARSENICUM ALBUM, BELLADONNA, CROTALUS HORRIDUS, HYOSCYAMUS NIGER, LACHESIS MUTUS, PYROGENIUM, APIS MELLIFICA, CARBO VEGETABILIS, LEDUM PALUSTREEnergique, Inc.c223c49d-c622-4e16-9148-813b892c9f5e2026-01-06WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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