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 20 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
unii: F5UM2KM3W7
Chamomilla Dec Cupro culta 3XCHAMOMILLA DEC CUPRO CULTA 3XUriel Pharmacy, Inc4d7af784-9f92-0dd5-e063-6394a90ab33b2026-03-20WarningsExact identifier
unii: G0R4UBI2ZZ
Emotional Detox and DrainageACONITUM NAPELLUS, ADRENALINUM, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, CALCAREA SULPHURICA, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, CORTISONE ACETICUM, CROCUS SATIVUS, DNA, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI BROMATUM, LACHESIS MUTUS, PULSATILLA (PRATENSIS), THYROIDINUM (BOVINE), VIOLA ODORATADeseret Biologicals, Inc.6b553600-5a90-4014-b02a-0992562bd2292026-03-20WarningsExact identifier
unii: U0NQ8555JD
Summit E2BENZALKONIUM CHLORIDER.L. Williams Companydec25905-5b08-4866-a2a5-4c60409761fc2026-03-19WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EarBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.82774eed-a906-4a19-86d9-05ea1462bd612026-03-18WarningsExact identifier
unii: W2469WNO6U
unii: 660YQ98I10
unii: G0R4UBI2ZZ
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
MediChoice OB CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.ed38fb97-b67d-430b-8f6b-4fc78c16aead2026-03-17WarningsExact identifier
unii: F5UM2KM3W7
Avant Alcohol-Free Instant Hand SanitizerBENZALKONIUM CHLORIDEB4 Soap LLCec561e3b-996e-484a-af64-f388f0fbfe5b2026-03-17WarningsExact identifier
unii: F5UM2KM3W7
SINUSCALM ALLERGYATROPA BELLADONNA. SPIGELIA ANTHELMIA. SANGUINARIA CANADENSIS ROOTBoiron4d3f554a-c8b2-3121-e063-6394a90a15982026-03-17WarningsExact identifier
unii: WQZ3G9PF0H
BronchiforceALTHAEA OFFICINALIS, RHEUM (PALMATUM), VERBASCUM THAPSUS, LOBELIA INFLATA, BELLADONNA, CUPRUM ACETICUM, DROSERA (ROTUNDIFOLIA), IPECACUANHA, SPONGIA TOSTA, STICTA PULMONARIABioActive Nutritional, Inc.c15e45a0-ba78-4572-88f1-7a35eeeb4abd2026-03-17WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.BM Private Limited4d22be93-c5f9-6ef3-e063-6294a90a7a8f2026-03-16WarningsExact identifier
unii: 660YQ98I10
Crane Safety BurnLIDOCAINECrane Safety LLC96d81566-6321-731e-e053-2995a90ad07d2026-03-16WarningsExact identifier
unii: F5UM2KM3W7
BM BIO10CALC PHOS, FERR PHOS, KALI MUR.BM Private Limited4d271d53-5a12-3567-e063-6294a90a37572026-03-16WarningsExact identifier
unii: 660YQ98I10
OP First Aid Series Antiseptic WipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4554-358e-e053-2995a90ae0ff2026-03-15WarningsExact identifier
unii: F5UM2KM3W7
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHURBioActive Nutritional, Inc.7e573986-60c2-40df-9e28-e7f1d9fe1a992026-03-13WarningsExact identifier
unii: 660YQ98I10
BIOPURE20CT ANTI BACTERIAL HAND WIPES(2010C)ANTIBACTERIAL HAND WIPEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.a9318c76-7c41-1634-e053-2a95a90a6d442026-03-13WarningsExact identifier
unii: F5UM2KM3W7
SimplyGreat Antibacterial wet wipesBENZALKONIUM CHLORIDESimply Great Brands LLC2ba2162b-941a-481d-e063-6394a90a54642026-03-12WarningsExact identifier
unii: F5UM2KM3W7
Foaming HandBENZALKONIUM CHLORIDENice-Pak Products, LLC2002c182-b4a6-4baa-8497-74570713b8bb2026-03-12Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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