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 111 of 134 · 2,673 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hygiene Clean Mahogany Teakwood Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5696369-175a-8add-e053-2995a90a5be82023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e8085d-8ab2-42c5-e053-2995a90aab372023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Luxury Clean Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda8fb1b-890e-b5c3-e053-2995a90a7b992023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Simple Hygiene Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INCb6fdf78f-4b9b-aca7-e053-2995a90a991c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lavender Blossom Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe34df37-d0ee-8d6a-e053-2a95a90aa2b52023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Leather Oak Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e77b4d-00b7-5c66-e053-2a95a90aa1742023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Vanilla Sugar Hand Sanitizer on the go and car safeBENZALKONIUM CHLORIDEUSA Broom LLCbbb44ec3-82ba-7053-e053-2995a90a69452023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INC0ebf85c5-21ee-4d14-b88f-d8c078791aef2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Vanilla Woods Hand Sanitizer Car Safe Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCbafee8b1-2b06-48c0-e053-2a95a90a72242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70f2b9-7a44-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffb0061-4347-7cd9-e053-2995a90ac1142023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Leather Oak Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5693dee-c75c-08b5-e053-2995a90a43902023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda861a1-2e25-528c-e053-2a95a90a985e2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569b768-319b-89a0-e053-2a95a90af9012023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Balsam Fir Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e77184-b325-6673-e053-2995a90a7d792023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Unscented Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffc6874-b7c6-726b-e053-2995a90a8b0f2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Spring Bloom Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe35349b-0f26-fa75-e053-2995a90a3b242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e7d11b-c5bf-5c00-e053-2a95a90a4bbc2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Blueberry Lemonade Hand Sanitizer Car Safe Alcohol-FreeBENZALKONIUM CHLORIDEUSA Broom LLCbafefe97-7365-06b3-e053-2a95a90a33482023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Pumpkin Spice Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb568ab0a-1108-9f0c-e053-2a95a90ab0ce2023-10-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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