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 7 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTOR INKS SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd56dc7a8-bee3-4eca-95cf-f1b0a6e2aad22026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
FoamyiQ Non-Alcohol Hand SanitizerFOAMYIQ NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8a2af2-0572-19b1-e053-2995a90a23ae2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Biodegradable Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Incd4e03834-d487-9f5d-e053-2a95a90a5e282026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Sanitizing Wipes Alcohol Free Fragrance FreeBENZALKONIUM CHLORIDEGoodEarth Distribution Llcd4de3289-5a00-5df4-e053-2995a90a9f3f2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEERC ACQUISITION, INC.00cd6f41-c9a8-b384-e063-6394a90a85752026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution Llcb92744a3-32aa-4aab-ab65-eba9a90e4c572026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc00ccdb15-7db9-0102-e063-6294a90a3ee32026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Hand Sanitizing Wipes Fragrance FreeBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc9886fa20-65c7-4deb-a1ae-0c3e52ba887e2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Ince805a12d-2bd8-4331-bd81-02c99d057acf2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc0ed4dcb8-857d-4631-89c9-66052b1d46312026-07-17WarningsExact identifier
unii: F5UM2KM3W7
24 7 life by 7 Eleven Antibacterial HAND WIPESBENZALKONIUM CHLORIDE7-ELEVEN, INC.56b2c8e4-254f-11b6-e063-6294a90a5bbb2026-07-16WarningsExact identifier
unii: F5UM2KM3W7
Non -Alcohol Grape Scented Hand SanitizerBENZALKONIUM CHLORIDEShenzhen Lantern Scicence Co.,Ltd.56b5c19e-cce5-16f8-e063-6394a90a1cbd2026-07-16WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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