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 83 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Total Solutions Alcohol-Free Hand Sanitizing WipesBENZALKONIUMAthea Laboratories, Inc.2ce0d8ad-2734-33df-e063-6394a90ab7282025-01-01WarningsExact identifier
unii: F5UM2KM3W7
Total Solutions Alcohol-Free Hand Sanitizing FoamBENZALKONIUMAthea Laboratories, Inc.2f37a2a1-5252-4052-e063-6294a90aef7f2025-01-01WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce2025-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Hawthorn Hygiene Solutions ENERGY ANTIBACTERIAL FOAM FRAGRANCE FREE 1200 mLBENZALKONIUM CHLORIDEBUNZL Distribution7fefd5c4-0bbf-4c25-a269-1440ae90e3dc2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Reliable Brand Powered by PURELL Antimicrobial Scented Foam CB10 1.2LBENZALKONIUM CHLORIDEVeritiv Operating Company61121dcd-adc0-41a6-82f4-c1902571cb7a2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
PURELL Antimicrobial Foaming HandBENZALKONIUM CHLORIDEGOJO Industries, Inc.fd5d9942-1cd3-4c40-84bf-beb4327682192024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Reliable Brand Powered by PURELL Antimicrobial Fragrance Free Foam CB10 1.2LBENZALKONIUM CHLORIDEVeritiv Operating Company3d96d8da-a820-4776-ae7d-5d0ca730dd302024-12-31WarningsExact identifier
unii: F5UM2KM3W7
PURELL Antimicrobial Fragrance Free Foaming Hand SPBENZALKONIUM CHLORIDEGOJO Industries, Inc.4477d823-3658-43ac-bb51-fd20888606c92024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Citrus Fresh Liquid AntimicrobialBENZALKONIUM CHLORIDEHillyard GMP8abcace0-08b7-45ea-8f4f-cc74417db58a2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Citrus Fresh Foaming AntimicrobialBENZALKONIUM CHLORIDEHillyard GMP086b7f58-59f3-429e-a2d8-8a5ffed0f8202024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Hillyard Alcohol Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDEHillyard GMPa066bd4e-8f1d-4dfe-8754-fc7fd5ae48f92024-12-30WarningsExact identifier
unii: F5UM2KM3W7
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Total Solutions Hygien HandBENZALKONIUMAthea Laboratories, Inc.fcd63fe4-a357-4432-a738-ae1bccbb8bae2024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Hillyard E2 Food Industry FoamingBENZALKONIUM CHLORIDEHillyard GMP81148442-6ee2-4655-85e4-27c2753c5c272024-12-30WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
unii: F5UM2KM3W7
TREE ANTIGENPOPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLENatural Creations, Inc8040ab36-90eb-4076-a478-9b82ccfa4ec92024-12-23WarningsExact identifier
unii: WQZ3G9PF0H
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
unii: F5UM2KM3W7
ARRAY Plum Scent Antibacterial Foam HandwashBENZALKONIUM CHLORIDEGordon Food Service, Inc.62ef137b-a2fe-4379-9d82-ff6b59667b7e2024-12-20WarningsExact identifier
unii: F5UM2KM3W7
AgroBac Pure FOAMBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.8b70a920-e63a-418f-8b79-f57eb5576b1a2024-12-20WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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