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 44 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dial Professional Antibacterial Defense Spring WaterBENZALKONIUM CHLORIDEHenkel Corporation29644a9d-3954-a6e5-e063-6394a90a82c72025-12-09WarningsExact identifier
unii: F5UM2KM3W7
Dial Professional Antibacterial Foaming Hand Wash Spring WaterDIAL PROFESSIONAL ANTIBACTERIAL FOAMING HAND SOAP SPRING WATER SCENTHenkel Corporation28dc867c-ca9b-4631-e063-6394a90a9a352025-12-09WarningsExact identifier
unii: F5UM2KM3W7
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Cartilago BetulaCARTILAGO BETULAUriel Pharmacy Inc.99037dd6-b2c8-45d0-bb5f-670aed53ee462025-12-08WarningsExact identifier
unii: U0NQ8555JD
BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry BerryBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics56b559c6-db10-47dd-9316-cc2d04cbef982025-12-08WarningsExact identifier
unii: F5UM2KM3W7
Babyganics Alcohol-Free Hand Sanitizer Wipes MandarinBENZALKONIUM CHLORIDEKAS Direct, LLCd93300b3-2c9b-4623-ae4b-907e857ce5ae2025-12-08WarningsExact identifier
unii: F5UM2KM3W7
Cough and BronchialACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America791a8da1-0de3-4798-bbc9-b3538ea28dd72025-12-08WarningsExact identifier
unii: U0NQ8555JD
Cough and Bronchial Daytime SyrupACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe Mexico, S.A. de C.V.e8949f67-1b05-40a2-96a5-d4d1124915ff2025-12-08WarningsExact identifier
unii: U0NQ8555JD
Sambucus Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
unii: U0NQ8555JD
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
unii: F5UM2KM3W7
BabyGanics Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics16d83c80-a1a6-490b-b065-35a10a36592f2025-12-05WarningsExact identifier
unii: F5UM2KM3W7
BabyGanics Alcohol-Free Foaming Hand Sanitizer MandarinBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics19304d65-aee9-42dd-aea8-61a7b8c9beb62025-12-05WarningsExact identifier
unii: F5UM2KM3W7
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial WipesBENZALKONIUM CHLORIDEERC Acquisition, Incdc6c39af-447c-481a-98b5-33b8f09b83bc2025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Sanitex Antibacterial Hand Wipes Fresh ScentBENZALKONIUM CHLORIDEPrecare Corp48907146-ca66-46e1-928b-a8f968a6bff82025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideDUAL ACTION ANTIBACTERIAL WIPESAvro Enterprises LLCcf42e470-19c8-2e11-e053-2995a90ae90d2025-12-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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