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 17 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Antibacterial LHSBENZALKONIUM CHLORIDEKroger Company0100d627-88e7-a80c-e063-6394a90a47972026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger AntibacterialBENZALKONIUM CHLORIDEKroger Company0100f324-0204-3aba-e063-6394a90a46932026-05-02WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS PHARMACY, INCe584a181-1226-5dda-e053-2a95a90ab6452026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care0970a4e2-c7b5-bcb7-e063-6394a90a43532026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
unii: F5UM2KM3W7
SCOTT FOAM HAND SANITIZERBENZALKONIUM CHLORIDEKimberly-Clark11234f21-04e4-4b16-88c3-51968a1cedca2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Summit 377Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDER.L. Williams Company50ae9765-2c2b-137f-e063-6294a90ae13a2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Vita Vie Antibacterial WashBENZALKONIUM CHLORIDESpa De Soleila83883b7-9b63-641b-e053-2995a90ab9432026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Dr Lift Advanced Antibacterial WipesBENZALKONIUM CHLORIDESpa de Soleilaf89bd25-784e-4828-e053-2995a90a8aaa2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Dr Lift Antibacterial Hand WashBENZALKONIUM CHLORIDESpa de Soleilab9e2c3c-d422-255e-e053-2a95a90a7a222026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Dr Lift Antibacterial Body ScrubBENZALKONIUM CHLORIDESpa de Soleilab9d6c73-29c1-036a-e053-2995a90a449c2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Snore Stop OralSprayATROPA BELLADONNA, EPHEDRA DISTACHYA FLOWERING TWIG, HISTAMINE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX VOMICA SEED, TEUCRIUM MARUMGreen Pharmaceuticals544dda7f-c748-eda7-e063-6394a90ab0912026-04-30WarningsExact identifier
unii: WQZ3G9PF0H
KLEENEX Foam Hand SanitizerBENZALKONIUM CHLORIDEKimberly-Clark1fa77ae2-b652-463d-8943-d338c591226e2026-04-29WarningsExact identifier
unii: F5UM2KM3W7
1438 DynaSoapANTIBACTERIAL HAND SOAPDynarex Corporationab0d5f64-9168-2ea3-e053-2a95a90a321e2026-04-29WarningsExact identifier
unii: F5UM2KM3W7
Summit 367 Antibacterial FoamBENZALKONIUM CHLORIDER.L. Williams Company509f2491-ea17-86ee-e063-6394a90a59402026-04-29WarningsExact identifier
unii: F5UM2KM3W7
E2 Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltd.aa7c24bb-cc66-3081-e053-2a95a90ada032026-04-29WarningsExact identifier
unii: F5UM2KM3W7
SCOTT Antimicrobial Foam Skin CleanserBENZALKONIUM CHLORIDEKimberly-Clark210f7da3-63c5-4a4b-8db0-8d6d1663751d2026-04-28WarningsExact identifier
unii: F5UM2KM3W7
anzoon ANTISEPTIC WIPESBENZETHONIUM CHLORIDE/BENZALKONIUM CHLORIDEShandong ACZ Biotechnology Co., Ltd.506cd089-f9a7-d9e5-e063-6394a90af6962026-04-27WarningsExact identifier
unii: F5UM2KM3W7
BelladonnaATROPA BELLADONNABoiron84771ac5-acf1-e0ec-e053-2a91aa0a1b362026-04-27Exact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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