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 131 of 134 · 2,668 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Kids ReliefCOLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSAHomeolab International (Canada) incdf8e8995-3106-4b21-acc4-24eeefd109fc2019-07-16WarningsExact identifier
unii: G0R4UBI2ZZ
Kids Relief Teething Oral LiquidCHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUIDHomeolab International (Canada) incdf6edd7a-3ca6-4946-b083-1193f4b1d2262019-07-16WarningsExact identifier
unii: G0R4UBI2ZZ
Potassium Chloride in DextrosePOTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Company45de5402-5e61-4bbd-8bbc-5e3392c9920e2019-07-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories431ff2ef-567c-4b60-af43-f4da61febaad2019-07-03Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
CPAP Mask cleaning wipesBENZETHONIUM CHLORIDE AND BENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.412e6fec-5af5-45f7-8c6b-393b884e161c2019-06-07WarningsExact identifier
unii: F5UM2KM3W7
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE EXTENDED-RELEASESolco Healthcare LLCf704b746-ab75-4484-8704-5baa94a077502019-04-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
BZK ToweletteBENZALKONIUM CHLORIDEAcme United Corporation866fdc1e-19b2-4d79-e053-2a91aa0a36fe2019-04-16WarningsExact identifier
unii: F5UM2KM3W7
Arnica Montana NartexARNICA MONTANA NARTEXNartex Laboratorios Homeopaticos SA DE CV86567f91-7792-1094-e053-2991aa0a4a0b2019-04-12WarningsExact identifier
unii: G0R4UBI2ZZ
Tinnitus ReliefCINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.Homeocare Laboratories30d67273-b9ec-4f3e-ace6-87a68325aaf12019-02-28WarningsExact identifier
unii: 660YQ98I10
Callington Anti-Bacterial Hand SanitiserBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.1c6650c9-29fa-4fba-8442-fe294a2087c02019-02-25WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in Sodium ChloridePOTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Companybecc7410-0a25-49f5-b0c3-240078479dc82019-01-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sciatica ReliefARNICA MONTANA FLOWER, BRYONIA ALBA WHOLE, MATRICARIA RECUTITA, PSEUDOGNAPHALIUM LUTEOALBUM LEAF, KALMIA LATIFOLIA LEAF, TOXICODENDRON PUBESCENS LEAF, VISCUM ALBUM LEAFHomeocare Laboratories5fbffd54-0007-4b9b-922f-1c0e450abd552018-12-31WarningsExact identifier
unii: G0R4UBI2ZZ
Eczema ReliefANTIMONY TRISULFIDE, APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, GRAPHITE, ARCTIUM LAPPA FRUIT, KEROSENE, SOLIDAGO CANADENSIS WHOLE, VIOLA TRICOLORHomeocare Laboratories1bfea3be-5909-4aa3-9ec3-05b4db2dd69b2018-12-31WarningsExact identifier
unii: WQZ3G9PF0H
Sore Throat ReliefACONITUM NAPELLUS,APIS MELLIFERA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,MERCURIUS SOLUBILIS,PHYTOLACCA AMERICANA ROOT.Homeocare Laboratoriesf8a65318-eb0f-48b4-9578-c7a6cf799bc12018-12-26WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
GUNA-SINUS NOSEALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -Guna spa36fef678-17c6-4d2a-a0f0-ddb298611f252018-12-22WarningsExact identifier
unii: W2469WNO6U
ThroatBAPTISIA, PHYTOLACCA, HYDRASTIS, APIS MEL, ARG NIT, BELLADONNA, HEPAR SULPH CALC, KALI BIC, LAC CAN, LACHESIS, MERC SOLUBNatural Creations, Incdf764380-46e2-46fc-9b5b-a2eca71bbfbf2018-12-21WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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