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 12 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-KIDNEYCHONDRODENDRON TOMENTOSUM ROOT - CLERODENDRANTHUS SPICATUS LEAF - EQUISETUM HYEMALE - ESCHERICHIA COLI - HIERACIUM PILOSELLA FLOWERING TOP - METHYLENE BLUE - NITRIC ACID - ONONIS CAMPESTRIS - PLANTAGO MAJOR - PORK KIDNEY - POTASSIUM NITRATE - PROTEUS VULGARIS - QUINHYDRONE - SARSAPARILLA - SOLIDAGO VIRGAUREA FLOWERING TOP - SUCCINIC ACID - SUS SCROFA URETER - SUS SCROFA URINARY BLADDER -Guna spa45c3c1af-e2b4-4239-98d9-f675c0e7d3222026-06-11WarningsExact identifier
unii: W2469WNO6U
BM BM43 DROPSCHAMOMILLA, CHELONE G., CINA, CINNABARIS, CUPRUM OXY. NIG., SANTONINE, TEUCRIUM MARBM Private Limited53f8e154-d647-0064-e063-6294a90a3f6c2026-06-11WarningsExact identifier
unii: G0R4UBI2ZZ
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
AntibacterialBENZALKONIUM CHLORIDERubbermaid Commercial Products LLC6023285c-6b02-410e-9492-df0543279f252026-06-11WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEWalgreen Company43c66c66-4e5f-4d02-82ec-66260adbef042026-06-11WarningsExact identifier
unii: F5UM2KM3W7
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBBM Private Limited53e7d586-805b-f1b3-e063-6294a90a118d2026-06-10WarningsExact identifier
unii: WQZ3G9PF0H
BM BM13 DROPSBELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTABM Private Limited53e86e23-8619-aef7-e063-6394a90ac38e2026-06-10WarningsExact identifier
unii: WQZ3G9PF0H
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.53ea8cec-bf36-4eec-e063-6394a90a559c2026-06-10WarningsExact identifier
unii: F5UM2KM3W7
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 660YQ98I10
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d39613-20bc-5877-e063-6394a90a0ee92026-06-09WarningsExact identifier
unii: 660YQ98I10
BM BM13BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTABM Private Limited53d42d09-d85e-64ee-e063-6294a90ab8ff2026-06-09WarningsExact identifier
unii: WQZ3G9PF0H
BM Kali MurKALI MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba82f3-be9f-51d7-e063-6394a90a877d2026-06-08WarningsExact identifier
unii: 660YQ98I10
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
TERRAMED JUST THINK COMFORT GYNOCARE FOR BACTERIAL VAGINOSIS SYMPTOMS RELIEFSODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,GOLDENSEAL,OLEA EUROPAEA OLIVE LEAF POWDERRida LLC1625d88d-5ac8-492a-a152-3047d168575a2026-06-08WarningsExact identifier
unii: MJ95C3OH47
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: WQZ3G9PF0H
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: WQZ3G9PF0H
Antibacterial Hand WashBENZALKONIUM CHLORIDERubbermaid Commercial Products LLCb71ba5ce-096e-4d56-831f-a2d208157ab72026-06-08WarningsExact identifier
unii: F5UM2KM3W7
Enriched Foam Alcohol-Free Hand SanitizerBENZALKONIUM CHLORIDERubbermaid Commercial Products LLC0a6456aa-69f7-476b-afbb-3dd69377e8b22026-06-05WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Foaming HandBENZALKONIUM CHLORIDECintas765ae77c-e48b-4996-82d1-cec8ed7c846f2026-06-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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