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 78 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 660YQ98I10
D-152ARSENIC TRIOXIDE, STRYCHNOS NUX-VOMICA SEED, ACONITUM NAPELLUS, GOLD, CAUSTICUM, HYOSCYAMUS NIGER LEAF, LACHESIS MUTA WHOLE, DAPHNE MEZEREUM WHOLE, ANEMONE PULSATILLA, SULFUR, AND VERATRUM VIRIDE WHOLEDNA Labs, Inc.e8968153-24c0-474d-8f4d-493481f442062025-01-13WarningsExact identifier
unii: U0NQ8555JD
D-139ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARBO VEGETABILIS, FERRUM PHOSPHORICUM, LYCOPODIUM, NATRUM PHOSPHORICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, HYDRASTISDNA Labs, Inc.e830774e-35c8-7309-e053-2995a90ae0432025-01-13WarningsExact identifier
unii: WQZ3G9PF0H
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
unii: F5UM2KM3W7
Sambucus Cold Flu Relief ElderberryPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECACSchwabe North America, Inc.5de8a3db-6103-4b69-8e47-c78bc7c6bfcd2025-01-10WarningsExact identifier
unii: U0NQ8555JD
Chemstation Q E2BENZALKONIUM CHLORIDEChemstation4a3e3617-56c3-6b64-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Chemstation HACCP Q E2BENZALKONIUM CHLORIDEChemStation4a39ce0a-5a26-6f30-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial 2X Ultra cleansingBENZALKONIUM CHLORIDESante Manufacturing Incca1899bb-126c-6bd6-e053-2995a90a14312025-01-09WarningsExact identifier
unii: F5UM2KM3W7
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC81a53ecd-2612-4efe-9491-415fff3f86e52025-01-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KleenLine NRG10 No-Touch Antimicrobial Foam Handwash Fragrance FreeBENZALKONIUM CHLORIDEEnvoy Solutions, LLCe49a7192-1a07-4c7e-9bf0-3402c69ad65f2025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a01c5f5-e9d9-5ac1-e053-2995a90a137e2025-01-09Exact identifier
unii: U0NQ8555JD
Victoria Bay Antimicrobial Foam Handwash 1200 mLBENZALKONIUM CHLORIDEDade Paper & Bag, LLCe3940912-48c1-4316-8ec3-02476df6c1c92025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a01ab86-eed0-5f1d-e053-2a95a90aff562025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a020fba-31b0-3b89-e053-2a95a90a9be62025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a022465-f2b8-b503-e053-2a95a90aec7d2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a02d6b6-5385-5ec4-e053-2a95a90a149a2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a01a463-54dc-6457-e053-2a95a90a35e62025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a029ec5-9459-981e-e053-2995a90a93592025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a029ce8-6ebb-ef94-e053-2a95a90ac7e52025-01-09Exact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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