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 48 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pre fenseBENZALKONIUM CHLORIDEPrefense LLCfad70060-8bb6-4b06-a353-666132f64c262025-11-21WarningsExact identifier
unii: F5UM2KM3W7
pre fense unscentedBENZALKONIUM CHLORIDEPrefense LLCa59e9bbf-b60e-970a-e053-2a95a90aaa5e2025-11-21WarningsExact identifier
unii: F5UM2KM3W7
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
unii: F5UM2KM3W7
ECZEMANICCOLUM SULPHURICUM, KALI BROMATUM, KALI MURIATICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, KALI SULPHURICUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC624d8671-43ce-46a8-87d3-d491fd9ba9132025-11-20WarningsExact identifier
unii: 660YQ98I10
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: 660YQ98I10
Tension HeadacheACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.897a3348-4d9d-4f74-a330-d6492baa4d032025-11-20WarningsExact identifier
unii: C9TD27U172
unii: U0NQ8555JD
COLD/FLU HPARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUMNatural Creations, Inc.11d945ea-3b03-42cc-b1c0-e4c517e386f62025-11-20WarningsExact identifier
unii: 660YQ98I10
Potassium chloridePOTASSIUM CHLORIDEAdvagen Pharma Ltd8000e242-fe20-4d02-8f7d-97298857cf4c2025-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEAvPAK6bb3f62d-79ce-cee6-8c6c-ee1eb6121f012025-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
AMERISILKBZKSHIELD LINE LLC43f9775c-0448-243e-e063-6294a90a9e222025-11-19WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial Hydrating Coconut MilkBENZALKONIUM CHLORIDEHenkel Corporation43f9be89-b434-75da-e063-6294a90a18642025-11-19WarningsExact identifier
unii: F5UM2KM3W7
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC61fe55c2-fc9a-4fae-899a-06601baa78e12025-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
unii: F5UM2KM3W7
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
unii: F5UM2KM3W7
Cartilago ArgentumCARTILAGO ARGENTUMUriel Pharmacy Inc.0f3bf8ce-0a60-4a79-e063-6294a90a39322025-11-18WarningsExact identifier
unii: U0NQ8555JD
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.018fc687-1fba-202e-e063-6294a90a5c9a2025-11-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lavender Quartz Ear OilLAVENDER QUARTZ EAR OILUriel Pharmacy Inc.b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c2025-11-17WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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