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 26 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Whispering RoseBENZALKONIUM CHLORIDER & R Lotion, Inc4a93b67c-7edc-28ad-e063-6394a90a1ac22026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Wet wipesBENZALKONIUM CHLORIDEZhejiang Easyclean Daily Chemical Co., Ltd.a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.49e31509-d489-44be-e063-6394a90a97ef2026-02-10WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VMY IMPORTS USA LLC4a849c4f-9b96-6b20-e063-6394a90a34862026-02-10WarningsExact identifier
unii: F5UM2KM3W7
dermveda NAIL FUNGUS SERUMOLIVE EXTRACT, SULFURCelcius Corp.6d999dac-7b84-4f19-957e-5c787a4e96c42026-02-09WarningsExact identifier
unii: MJ95C3OH47
Everlit Care Products Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3331e2f1-c3d0-41fc-a792-be5dcdf4e24a2026-02-09WarningsExact identifier
unii: F5UM2KM3W7
dermveda SCABIES ITCH RELIEF SERUMOLIVE EXTRACT, SULFURCelcius Corp.86a8bffd-81a8-4f22-89b6-e51158f336db2026-02-09WarningsExact identifier
unii: MJ95C3OH47
dermveda JOCK ITCHOLIVE EXTRACT, SULFURCelcius Corp.252ed439-0e4c-419f-8b34-d1b52da8464f2026-02-06WarningsExact identifier
unii: MJ95C3OH47
Hand WashBENZALKONIUM CHLORIDESalado Sales Inc.3803d8d6-ed43-4dcf-ba04-92914bfa5e9a2026-02-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Foaming Hand WashBENZALKONIUM CHLORIDESalado Sales Inc.b56aefb5-7134-44dd-b341-b9a3515db35e2026-02-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Aquarrelle Antibacterial Wipes 40BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.3584680e-71b0-23b6-e063-6294a90a69982026-02-05WarningsExact identifier
unii: F5UM2KM3W7
Aquarrelle Antibacterial Wipes 20BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.35865d33-a99f-1b37-e063-6394a90a00d22026-02-05WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDEPharmacy Value Alliance, LLC5f9521f2-53f2-4d7e-9116-36e94e2d06952026-02-05Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: 660YQ98I10
Zehn Antiseptic Sanitizing WipesBENZALKONIUM CHLORIDEZehn Wipes1c7bfc17-e552-1f51-e063-6394a90a24ac2026-02-04WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIALBENZALKONIUM CHLORIDETopco Associates LLC463f3a53-921a-65cb-e063-6394a90ab4f22026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tork Hand Washing Antibacterial FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC0f72f0cb-9e8e-43bb-862e-0024771ece1b2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tork Hand Sanitizing Alcohol-Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCc9761e9d-21d5-4dcd-8e31-bb722c5178912026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand SanitizerBENZALKONIUM CHLORIDE 0.1%W/WGeorgia-Pacific Consumer Products LPd4575f18-d96c-465d-8580-650ee7df18f62026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Pacific Blue UltraBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP7ea3f69f-e150-4beb-af1e-04ffc5a3b7952026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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