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 15 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tazza ECOFIT WIPESBENZALKONIUM CHLORIDETazza Brands East Inc50a83324-cc13-3668-e063-6394a90a44ed2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
unii: F5UM2KM3W7
crisp pearBENZALKONIUM CHLORIDELIDL US LLCca58d78e-a85a-da96-e053-2995a90a60a92026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HIMarkBENZALKONIUM CHLORIDEApollo Health and Beauty Caref96022c6-268b-9085-e053-6294a90a0e3f2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Better Living BrandsBENZALKONIUM CHLORIDEBetter Living Brands LLCee53ceaf-8709-459b-e053-2995a90a05e02026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacye56e908d-a372-5f3a-e053-2a95a90ac5f62026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Gold LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care1e1459c8-0c8a-0e40-e063-6294a90a53742026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify White Tea LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d72396-2aeb-f8f3-e063-6394a90a9ec82026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify Crisp Clean LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d75a2f-8b82-924c-e063-6294a90ae09c2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One RegularBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25a7fc33-4d6a-3a67-e063-6294a90a44652026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One Crisp CleanBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b33a18-0b14-5411-e063-6294a90a31ee2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One Fresh CitrusBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b338fc-8f03-5eb6-e063-6294a90aacc52026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One White Tea and BerryBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b385b5-bef8-b9c0-e063-6294a90ad4852026-05-08WarningsExact identifier
unii: F5UM2KM3W7
UP and UPBENZALKONIUM CHLORIDETARGET CORPORATION INC.39855595-cd79-a116-e063-6294a90a96382026-05-08WarningsExact identifier
unii: F5UM2KM3W7
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda94f82d-42aa-41e8-e053-2995a90a83812026-05-08WarningsExact identifier
unii: F5UM2KM3W7
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda96ccad-bf6d-7634-e053-2995a90abc472026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify Clean and Protect Cool Splash LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d8b8a8-9d15-ad76-e063-6294a90a05212026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBWENZALKONIUM CHLORIDEApollo Health and Beauty Care42f5125b-3b72-4154-e063-6394a90a83c32026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Hyvee Foaming LHS-PearBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f55d37-c234-acaa-e063-6394a90ae4532026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Discount Drug MartBENZALKONIUM CHLORIDEApollo Health and Beauty Care46b44696-8a1a-9ecf-e063-6394a90a42532026-05-08WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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