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 25 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand WashBENZALKONIUM CHLORIDEVeritiv Operating Company3b4f27c8-6a1c-2823-e063-6294a90a47ad2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Valu Merchandisers Companyfb9071d7-e44a-47fc-b76d-faf6220a57bf2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
unii: F5UM2KM3W7
ColdCalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae2f15e-45f3-e2e4-e063-6294a90a92bc2026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae45fc7-c0f4-3770-e063-6394a90ac80e2026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
KREOSOTEACID NIT, BELLADONNA, BORAX, CHAMOMILLA, KREOSOTE, MERC SOL, STAPHYSAGRIABM Private Limited3b3cb32b-e7e3-3455-e063-6394a90aaafb2026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
SinusCalmATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA WHOLEBoiron4ae58d81-3952-b372-e063-6394a90a84992026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Wakefern Food Corp.d4e823bc-527b-4815-a7e0-47ee8d004e632026-02-13Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: 660YQ98I10
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Your Military Exchanges8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2b2026-02-12Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEMajor Pharmaceuticals33ad1eb2-1f05-461c-b01d-82dee42315562026-02-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Cucumber Mint BlissBENZALKONIUM CHLORIDER & R Lotion, Inc458dec24-b5bb-240a-e063-6294a90a81f32026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Vanilla Sugar BlissBENZALKONIUM CHLORIDER & R Lotion, Inc4a6b89dc-1c0a-61e2-e063-6294a90aeca82026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Island TranquilityBENZALKONIUM CHLORIDER & R Lotion, Inc4a7c2d9a-4bf1-d4a8-e063-6394a90ae1722026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDER & R Lotion, Inc3ba7408c-7165-448c-b31c-9890807c0cb92026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Eucalyptus TranquilityBENZALKONIUM CHLORIDER & R Lotion, Inc4a8243c4-969b-a123-e063-6394a90a342a2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
CleanseBENZALKONIUM CHLORIDE 0.13%Medline Industries, LP3c56b4c2-42f5-66d7-e054-00144ff8d46c2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
CleanseBENZALKONIUM CHLORIDEMedline Industries, LP428644dd-b2e5-1675-e054-00144ff88e882026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Incc4328104-5a17-4673-925b-3d3206994e6e2026-02-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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