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 81 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
StellaLife VEGA Oral Care RinseRINSEStellaLife, Inc.46f3b20e-1ed9-0d1e-e054-00144ff88e882025-01-08WarningsExact identifier
unii: W2469WNO6U
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc00179db3-5a76-4724-a848-28e71eb580a62025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc3e65e67d-c7d0-2fcb-e054-00144ff8d46c2025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Aqua Clear 2X UltraBENZALKONIUM CHLORIDESante Manufacturing Incd5d15729-1dc1-2b44-e053-2a95a90a26c52025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Plantain Spruce CoughPLANTAIN SPRUCE COUGHUriel Pharmacy Inc.d6a99616-4a08-0909-e053-2995a90a0d2f2025-01-07WarningsExact identifier
unii: WQZ3G9PF0H
Lachesis BelladonnaLACHESIS BELLADONNAUriel Pharmacy Inc.c617a849-5043-43cd-974f-2f0d664fd4682025-01-07WarningsExact identifier
unii: WQZ3G9PF0H
Sipa hand sanitizer S.pray with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbc3c5d-c231-9024-e053-6294a90a9c592025-01-07WarningsExact identifier
unii: F5UM2KM3W7
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: WQZ3G9PF0H
Ormadus Foodservice Antibacterial FoamBENZALKONIUM CHLORIDESC Johnson Professional USA Inc71cd4be3-1cdf-4e49-be7b-405fe12288d22025-01-07WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial BathingBENZALKONIUM CHLORIDECardinal Health, Inc.586463f3-d117-47ae-bbab-f7caff1f5fa82025-01-06WarningsExact identifier
unii: F5UM2KM3W7
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
unii: F5UM2KM3W7
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufcaturing Inc205eb8f9-55fd-266e-e063-6294a90a4b3e2025-01-03WarningsExact identifier
unii: F5UM2KM3W7
Sipa Foam hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcb9fe65-837c-011b-e053-6294a90a46052025-01-02WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufacturing Inc3e64d344-8883-0235-e054-00144ff8d46c2025-01-02WarningsExact identifier
unii: F5UM2KM3W7
Cardioforce IARNICA MONTANA, CACTUS GRANDIFLORUS, CAPSICUM ANNUUM, DIGITALIS PURPUREA, KALI PHOSPHORICUM, LAUROCERASUS, SPIGELIA ANTHELMIA, TABACUM, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, AURUM MURIATICUM, GLONOINUM, IGNATIA AMARA, KALMIA LATIFOLIA, LATRODECTUS MACTANS, VALERIANA OFFICINALISBioActive Nutritional, Inc.506c0d88-d888-4f7a-b8de-cb00482c25372025-01-02WarningsExact identifier
unii: U0NQ8555JD
Dial refresh and renew Antibacterial whiteBENZALKONIUM CHLORIDEHenkel Corporationf7f5ed83-1b9b-230a-e053-6394a90ad2ae2025-01-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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