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 50 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
SunDrops 77BENZALKONIUM CHLORIDESunburst Chemicals, Inc.fc0ba65c-5307-4251-a60b-cde84ad56ad82025-11-11WarningsExact identifier
unii: F5UM2KM3W7
SunDrops 87BENZALKONIUM CHLORIDESunburst Chemicals, Inc.584ea129-aaf2-402f-b9f1-3fec2a23a21c2025-11-11WarningsExact identifier
unii: F5UM2KM3W7
Arnica AconitumARNICA ACONITUMUriel Pharmacy Inc.ba2a81b4-9efc-4706-9330-97475a27dc822025-11-11WarningsExact identifier
unii: U0NQ8555JD
Smart Care Crayola ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAshtel Studios, Inc.9ff664f0-8198-4d68-8b99-695c7ef56d062025-11-11WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories3709ee9a-f885-4a75-ab51-36e9e1ef04272025-11-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dial Antibacterial Defense Orchid Rose Bliss ScentBENZALKONIUM CHLORIDEHenkel Corporation285f8493-d4bf-0da1-e063-6394a90a42cc2025-11-10WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBluepoint Laboratoriesd605ca36-2bfa-42cb-a46c-8ecb3162994e2025-11-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: 660YQ98I10
LUMO Heal Seasonal Flu CompanionARSENICUM ALBUM, EUPATORIUM PERFOLIATUM, KALI MURIATICUM, STICTA PULMONARIAApplied Bioenergetics, LLCda6b6258-f91e-4283-aeb2-54e7885a80b82025-11-10WarningsExact identifier
unii: 660YQ98I10
Foaming Hand SanitizerHAND SANITIZERAmerican Chemical Systems II, LLC3085d595-68b7-4100-81c0-f0699a7609d62025-11-10WarningsExact identifier
unii: F5UM2KM3W7
Genuine First Aid Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.48867a79-4d21-4ba1-9cf9-7839352a4b7e2025-11-07WarningsExact identifier
unii: F5UM2KM3W7
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.8367a2ae-dfd9-4515-838c-529920291ca02025-11-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack2feda15e-f325-41fe-a442-41a8cc62b8552025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEA-S Medication Solutionsd486f982-a7d3-463d-a68d-89365ddaf5bb2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
AB 3000BENZALKONIUM CHLORIDEChemco892c8911-9f1a-4c0c-9106-6d9a90d577a92025-11-06WarningsExact identifier
unii: F5UM2KM3W7
Strike Bac Antibacterial HandBENZALKONIUM CHLORIDEGenlabs Corporation4014aa67-8016-40c5-88ec-daec9dba4f452025-11-06WarningsExact identifier
unii: F5UM2KM3W7
Aconitum e tub. 30ACONITUM E TUB. 30Uriel Pharmacy Inc.8b80552a-6ae3-40ea-bf41-5cd705be04f22025-11-06WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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