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 118 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TraumeelACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOTBiologische Heilmittel Heel9ff5c743-0e8f-4416-9964-c92b3abb54dd2023-03-06WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
BelladonnaATROPA BELLADONNABoiron85006162-c1ef-4978-e053-2a91aa0adbc42023-03-03Exact identifier
unii: WQZ3G9PF0H
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
INFL CombinationEUCALYPTUS GLOBULUS, IPECACUANHA, ACONITUM NAPELLUS, ADENOVIREN NOSODE, INFLUENZINUM 2021-2022, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KREOSOTUM, VERATRUM VIRIDEDeseret Biologicals, Inc.e54d3fc8-e9a7-424c-a0d8-3325e00db5ee2023-02-27WarningsExact identifier
unii: U0NQ8555JD
Potassium ChloridePOTASSIUM CHLORIDEFresenius Kabi USA, LLCfcd4f458-ce27-417e-9bb6-de1cc49d44b92023-02-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sciatic FormulaKALI IODATUM, RUTA GRAVEOLENS, AMMONIUM MURIATICUM, BELLADONNA, GNAPHALIUM POLYCEPHALUM, COLOCYNTHIS, ACONITUM NAPELLUS, NUX VOMICA, ARSENICUM ALBUMNutritional Specialties, Inc.76c5cb3f-0f1b-47b8-a492-592ff440c7da2023-02-22WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: G0R4UBI2ZZ
BelladonnaATROPA BELLADONNABoiron8476aaf1-b41a-747a-e053-2991aa0a07952023-02-20Exact identifier
unii: WQZ3G9PF0H
BelladonnaATROPA BELLADONNABoiron84fffe54-29e2-4fd9-e053-2a91aa0a17bb2023-02-20Exact identifier
unii: WQZ3G9PF0H
BelladonnaATROPA BELLADONNABoiron8476e7a6-bc58-2462-e053-2a91aa0a3b932023-02-20Exact identifier
unii: WQZ3G9PF0H
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions87cc7349-5a07-4a39-be97-4e1013814f302023-02-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
THROATCALMARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, MERCURIUS SOLUBILIS, BROMINE, BRYONIA ALBA ROOT, ARNICA MONTANA, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTEDBoironde97d002-de84-bcef-e053-2995a90a319b2023-01-31Exact identifier
unii: WQZ3G9PF0H
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEGranules Pharmaceuticals Inc.9f8d2886-9ecd-4cbf-a84a-2d221cb3497c2023-01-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Pain and Fatigue ReliefACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company7c689153-2002-421d-b573-76b0052550e02023-01-26WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
STOPAIN CLINICAL Migraine and HeadacheMENTHOL, UNSPECIFIED FORM, ATROPA BELLADONNA, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOTTroy Manufacturing, Inc.c5b690ce-7bb6-4840-b00b-205cd5bc6be62023-01-25WarningsExact identifier
unii: WQZ3G9PF0H
Plantago majorPLANTAGO MAJORBoiron8697c029-36f8-a2e6-e053-2a91aa0a013c2023-01-23Exact identifier
unii: W2469WNO6U
BelladonnaATROPA BELLADONNABoiron84ffe1b8-0fa0-0da1-e053-2a91aa0a30ed2023-01-23Exact identifier
unii: WQZ3G9PF0H
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608d5a3-93e6-e8e2-e053-2a91aa0aaedc2023-01-23Exact identifier
unii: 660YQ98I10
SINUSCALM ALLERGYATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT,Boirone4e0b0b3-df5e-6d47-e053-2a95a90aeba82023-01-18Exact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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