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 71 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RexallEar Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURDolgencorp LLC59cfc7b4-faf0-4794-8911-d8745e12c6b82025-02-28WarningsExact identifier
unii: G0R4UBI2ZZ
Meijer Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURMeijer Distribution Inc8ff0fa61-964e-77a8-e053-2a95a90a2d3a2025-02-28WarningsExact identifier
unii: G0R4UBI2ZZ
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labsbf632e1d-73f3-4df1-ad12-e555fa6a56e92025-02-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Genexa Kids SleepologyALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALISGenexa Inc.ba0cd3c2-9883-9664-e053-2995a90a9fd42025-02-26WarningsExact identifier
unii: G0R4UBI2ZZ
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM197RHUS TOX, BRYONIA, COLOCYNTHIS, ARSENICUM ALBUM, HYPERICUM, CHAMOMILLA, GNAPHALLIUMBestmade Natural Products2ef5a641-e45a-bafc-e063-6394a90a1b5d2025-02-25WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM201ARS ALB, BRYONIA, CHAMOMILLA, COLOCYNTHIS, NUX VOMICA, RHUS TOXBestmade Natural Products2ef7632e-dc8a-6b21-e063-6294a90ac2dd2025-02-25WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM184BENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REPBestmade Natural Products2e9211e3-0e20-741e-e063-6394a90a4da12025-02-20WarningsExact identifier
unii: WQZ3G9PF0H
Bestmade Natural Products BM172AURUM IOD, BELLADONNA, GUIACUM, HEPAR SULP, IODIUM, LAUROCERASUS, PHYTOLACCA DECBestmade Natural Products2e7d1eee-9290-17e0-e063-6394a90a9eb82025-02-19WarningsExact identifier
unii: WQZ3G9PF0H
Bestmade Natural Products BM176ACONITE NAP, ARS ALB, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, LEDUM PAL, SULPHURBestmade Natural Products2e7e7a3c-5b60-20e2-e063-6294a90ae2892025-02-19WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bestmade Natural Products BM179ACONITE, CACTUS GRAND, CRATAEGUS OXY, DIGITALIS PUR, GLONOINE, MAG PHOS, SPIGELIA, STROPHANTHUSBestmade Natural Products2e818a28-a5cc-5c98-e063-6294a90a51f32025-02-19WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products BM180ACONITE NAP, ARGENTUM NIT, CHAMOMILLA, CYCLAMEN, GELSEMIUM, IGNATIA, MAG MUR, MOSCHUS, NUX VOMICABestmade Natural Products2e8259e9-087f-8e19-e063-6294a90ab0842025-02-19WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Bestmade Natural Products BM147DULCAMARA, FERR PHOS, LYCOPODIUM, PLANTAGO MAJ, PULSATILLA, STIGMATA MAYBestmade Natural Products2e696a0e-7767-d6cc-e063-6394a90aee892025-02-18WarningsExact identifier
unii: W2469WNO6U
Bestmade Natural Products BM151BELLADONNA, BENZOIC ACID, CAUSTICUM, EQUISETUM, GELSEMIUM, RHUS AROM, VERBASCUMBestmade Natural Products2e6a469d-026f-41b0-e063-6394a90abd792025-02-18WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
Bestmade Natural Products BM148BELLADONNA, COLOCYNTHIS, COLEUS AROM, DIOSCOREA VILL, LUPULINUM, RHUS TOXBestmade Natural Products2e6a477a-c500-846a-e063-6294a90a14982025-02-18WarningsExact identifier
unii: WQZ3G9PF0H
Bestmade Natural Products BM152ACONITE, ANTI TART, BELLADONNA, CYCLAMEN, DULCAMARA, SULPHURBestmade Natural Products2e6aa8e8-22fa-687f-e063-6394a90a38022025-02-18WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Bestmade Natural Products BM155ARNICA, BELLADONNA, FERR PHOS, HAMAMELIS, IPECAC, KALI MUR, MILLEFOLIUMBestmade Natural Products2e6b62c4-b088-136f-e063-6294a90a5fa22025-02-18WarningsExact identifier
unii: 660YQ98I10
unii: WQZ3G9PF0H
Bestmade Natural Products BM163ANACARDIUM, KALI MUR, KALI SULPH, KALI BICH, KALI IOD, BARIUM IOD, POTHOS FOETIDABestmade Natural Products2e6db742-7f2d-ee6b-e063-6294a90aea2d2025-02-18WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BM165GRINDELIA, ANGELICA ATRO, SILPHIUM LAC, BALSUM PER, KALI MUR, KALI BICH, KALI IOD, BARIUM MURBestmade Natural Products2e6e7960-b502-54c6-e063-6394a90add702025-02-18WarningsExact identifier
unii: 660YQ98I10
Inverness EAR CARE ANTISEPTICBENZALKONIUM CHLORIDEThe Richline Groupac42d2f1-69e3-45f6-8002-d45ebed5ee222025-02-17WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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