FDA.reportPublic FDA data

NDC 64616-045-01 - 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
64616-045
Requested NDC
64616-045-01
Package NDCs from labels
64616-045-01, 64616-045-02
Manufacturer
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.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-045-01Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID1510
64616-045-02Earache Remedy1 in 1 CARTONLIQUID110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-045EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]9Current NDC, Legacy NDC, 2 package rows20241212_49afb2c3-ee42-4be9-943a-36d73ded0004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2

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 31 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Antiseptic SwabBENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.94043f4e-fe47-4b6f-8354-30697daaed812026-01-12WarningsExact identifier
unii: F5UM2KM3W7
ABACONITUM NAPELLUS, BRYONIA CRETICAMARCO PHARMA INTERNATIONAL LLC2d81c13f-102a-6741-e063-6294a90aee842026-01-12WarningsExact identifier
unii: U0NQ8555JD
ABCACONITUM NAPELLUS, BELLADONNA, CHAMOMILLAMARCO PHARMA INTERNATIONAL LLC44749e04-ca70-410d-a754-8befe8da11e72026-01-12WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
INFL CombinationACONITUM NAPELLUS, ADENOVIREN NOSODE, BRYONIA (ALBA), EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM 2023-2024, IPECACUANHA, KREOSOTUM, VERATRUM VIRIDEDeseret Biologicals, Inc.d8d1d7b9-97f0-4b71-a589-af7c890a31602026-01-09WarningsExact identifier
unii: U0NQ8555JD
Lung DrainageANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.fd109172-46c3-444e-9fa0-124f785c3fb52026-01-09WarningsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAvPAKf32df7c0-33eb-e6d6-e053-2a95a90a2e8d2026-01-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products1e2cb45c-7e70-01dd-e063-6294a90aa16b2026-01-09WarningsExact identifier
unii: F5UM2KM3W7
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products063a1e99-dda6-9cb9-e063-6294a90aa1b32026-01-09WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare Corporation092ddee4-572d-4771-8d95-880cea01097e2026-01-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Otitis Media Drops 2153OTITIS MEDIA DROPSProfessional Complementary Health Formulas9e8b60e9-0bd7-4c6c-99fa-cb87a9c831722026-01-08WarningsExact identifier
unii: U0NQ8555JD
Cerebral Blood Stim Drops 2086CEREBRAL BLOOD STIM DROPSProfessional Complementary Health Formulasee501d10-085e-4051-8702-587d4266cede2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: W2469WNO6U
Cough Tonic 2995COUGH TONICProfessional Complementary Health Formulas71d46da9-9e1d-43da-8664-b5579e9fd4e32026-01-08WarningsExact identifier
unii: U0NQ8555JD
Facial Pain Drops 2023FACIAL PAIN DROPSProfessional Complementary Health Formulasb23ed9f3-d230-467c-b8fa-c2a9a6f99f872026-01-08WarningsExact identifier
unii: U0NQ8555JD
Staph/Strep/Respiratory Nosode Combination 9418STAPH/STREP/RESPIRATORY NOSODE COMBINATIONProfessional Complementary Health Formulas9981ec07-9bda-4789-9061-9e89de9ee8ed2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: W2469WNO6U
Rhododendron Combination 9241RHODODENDRON COMBINATIONProfessional Complementary Health Formulas9a3d93c9-261d-4711-ad75-8e4c1f87c9362026-01-08WarningsExact identifier
unii: U0NQ8555JD
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: U0NQ8555JD
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
unii: F5UM2KM3W7
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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