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 30 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Viscum BelladonnaVISCUM BELLADONNAUriel Pharmacy Inc.a4865726-445e-4cb7-b7c8-5b74b8dd48162026-01-16WarningsExact identifier
unii: WQZ3G9PF0H
Pulmo EchinaceaPULMO ECHINACEAUriel Pharmacy Inc.14c19a33-ffcc-4b35-a0cc-9f8d44cbaf662026-01-16WarningsExact identifier
unii: WQZ3G9PF0H
Apis BelladonnaAPIS BELLADONNAUriel Pharmacy Inc.8db74171-1580-4459-a3d2-5862ef6aa8272026-01-16WarningsExact identifier
unii: WQZ3G9PF0H
Walgreens Antibacterial Hand WipesBENZALKONIUM CHLORIDEWalgreen Co.61aed8f1-ddf6-41d0-9d12-8affc43265d62026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEAvKARE755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c62026-01-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Hy-Vee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care3f82ea8b-87cf-fd28-e063-6394a90a50152026-01-13WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEAdvagen Pharma Limitedd528c0c1-b81f-4f7a-8518-e6911b23c3eb2026-01-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Insomnia ReliefINSOMNIA RELIEFHomeocare Laboratories22db7d8d-8611-4f8c-be47-af82a237f9382026-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
RENOWN Antibacterial Plum HandwashBENZALKONIUM CHLORIDEHome Depot U.S.A., Inc.b577c676-10d0-4b4a-ace8-4e21a771929d2026-01-13WarningsExact identifier
unii: F5UM2KM3W7
Antimicrobial Foaming Hand SanitizerBENZALKONIUM CHLORIDESaraya Healthcare3075e40b-41c3-56c6-e054-00144ff88e882026-01-13WarningsExact identifier
unii: F5UM2KM3W7
HygienePoint Advance Antibacterial F oam Hand CleanerBENZALKONIUM CHLORIDETriple S a.k.a Standardized Sanitation Systems, Inc12fb4d45-a2c1-4950-ac90-e64e4be76bd42026-01-13WarningsExact identifier
unii: F5UM2KM3W7
Arthritis ReliefARNICA MONTANA, BRYONIA ALBA, CHAMOMILLA,HYPERICUM PERFORATUM, KALMIA LATIFOLIA LEAF,KALMIA LATIFOLIA LEAFHomeocare Laboratories818cbfb4-b5f4-415c-ba9f-5305efe559532026-01-12WarningsExact identifier
unii: G0R4UBI2ZZ
COLD and FLU RELIEFCOLD AND FLU RELIEFClineva Management Services, LLC544c918d-86cc-1f8d-e054-00144ff8d46c2026-01-12WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
Headache ReliefATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARKHomeocare Laboratories47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f2026-01-12WarningsExact identifier
unii: WQZ3G9PF0H
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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