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 112 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
X3 Clean Foaming Hand SanitizerBENZALKONIUM CHLORIDEHK Kolmar Canada, Inc3c636145-03fe-47c7-81fc-279fef69b1c32023-10-27WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70ed1c-83db-5eaa-e053-2a95a90a92cc2023-10-27WarningsExact identifier
unii: F5UM2KM3W7
Pine and Honey Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC95b0c8b2-901b-40f8-ae75-732c3821ee472023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Vanilla Coconut Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC1932ccc6-6b8c-4dc4-bf74-1a155b596f3b2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Mountain Air Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INCc80fc58e-e2a5-4c8e-a211-abe81fc1231d2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Simply Lavender Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC8a75bcab-5a4b-4e3b-a838-2f2ce0224b8d2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
g and h Protect HandBENZALKONIUM CHLORIDEAccess Business Group LLC1103a4af-10d6-478f-85cd-c364569569e52023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
unii: F5UM2KM3W7
WIPE OUT Antibacterial Wipes, Lemon ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd72ac9-d6e8-75ec-e053-2a95a90a141d2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
WIPE OUT Antibacterial Wipes, Fresh ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd76301-e165-7098-e053-2995a90a29262023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic Towelette SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdf787ff2f-0cdf-46ee-b401-603e34a767702023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic Towelette Non-SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd481dd61c-7691-44dc-83b4-c1ee6898c3be2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Cleansing ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd13c23da8-51d7-480c-b8ae-5bf91043d0a32023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic BZK ToweletteBENZALKONIUM CHLORIDECardinal Health 200, Inc.8dd79ffe-f742-438c-9814-612f900ad6a92023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizing WipesBENZALKONIUM CHLORIDEEz Products Of South Florida, LLC89dab85e-4888-442a-b8a1-4f23d356f5952023-10-23WarningsExact identifier
unii: F5UM2KM3W7
New Wave Cleaning Solutions Foaming Hand SanitizerBENZALKONIUM CHLORIDENEW WAVE CLEANING SOLUTIONS,LLCb79b2f50-4d87-5b75-e053-2995a90a40d42023-10-23WarningsExact identifier
unii: F5UM2KM3W7
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
unii: F5UM2KM3W7
Decon7 Antiseptic Foaming Hand SanitizerBENZALKONIUM CHLORIDEDecon7 Systems, LLCd167abde-6cfe-e61a-e053-2995a90accf92023-10-16WarningsExact identifier
unii: F5UM2KM3W7
Kali muriaticumPOTASSIUM CHLORIDEBoironcaaad470-7be1-11e6-b409-424c583030312023-10-16Exact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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