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 21 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Nice-Pak Products, LLCff006333-6263-4654-bfc2-4f6a4230a82a2026-03-12Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
B-ForceECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, PROTEUS (MORGANI), SALMONELLA TYPHI NOSODE, CLOSTRIDIUM PERFRINGENSBioActive Nutritional, Inc.0ccc9d9a-58d4-4957-91a3-4e8c04d1c86d2026-03-11WarningsExact identifier
unii: WQZ3G9PF0H
Foaming HandBENZALKONIUM CHLORIDEUpLift Brands, LLCa4bdb4a3-5706-4676-a6d3-22971f023dba2026-03-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%UpLift Brands LLC6e42ce0e-98dd-4fd6-b307-dea66d9b3df02026-03-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEUpLift Brands, LLCdd992633-05fd-4544-8abe-e161828a99ad2026-03-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Cherry BlossomBENZALKONIUM CHLORIDEUpLift Brands, LLC30b2f298-9aa0-41e7-9124-15ee8e58b1482026-03-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand Wash Spring RainBENZALKONIUM CHLORIDEUpLift Brands, LLC18061e1b-fc59-4824-8057-7f3e4935d7812026-03-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WashBENZALKONIUM CHLORIDEUpLift Brands LLC2e9a5253-f68d-4db5-a479-2663fc7789af2026-03-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepackff44dcd5-b255-4d80-83ee-3c8f922c99eb2026-03-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: 660YQ98I10
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: G0R4UBI2ZZ
Restless Leg Symptom ReliefARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOX, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM AND ZINCUM METALLICUM.King Bio Inc.07ab09eb-9430-4ea2-90c0-db2ca237cc962026-03-10WarningsExact identifier
unii: G0R4UBI2ZZ
Sore Throat and LaryngitisACONITUM NAPELLUS, ANTIMONIUM CRUDUM, ARUM TRIPHYLLUM, BORAX, CAUSTICUM, FERRUM PHOS, GRAPHITES, HEPAR SULPH CALC, KALI BICHROMICUM, PHOSPHORUS, SELENIUM METALLICUM AND SPONGIA TOSTA.King Bio Inc.44129cd3-d525-494e-b60e-2b0aafbeb8ea2026-03-10WarningsExact identifier
unii: U0NQ8555JD
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: U0NQ8555JD
ConvoforceBELLADONNA, BUFO RANA, CICUTA VIROSA, CINA, CUPRUM METALLICUM, HYOSCYAMUS NIGER, MOSCHUS, STRAMONIUMBioActive Nutritional, Inc.e9729c5c-6b64-4aac-9710-66fe8dc998f92026-03-10WarningsExact identifier
unii: WQZ3G9PF0H
Respitory Tonic FECHINACEA (ANGUSTIFOLIA), UVA-URSI, BAPTISIA TINCTORIA, CONVALLARIA MAJALIS, KALI MURIATICUM, PINUS SYLVESTRIS, THUJA OCCIDENTALIS, BRYONIA (ALBA), CONDURANGO, CROTALUS HORRIDUS, GINKGO BILOBA, LACHESIS MUTUS, SELENIUM METALLICUM, TABEBUIA IMPETIGINOSA, VISCUM ALBUMBioActive Nutritional, Inc.17684967-1e3c-4776-9ae9-d43fa1ebebb12026-03-09WarningsExact identifier
unii: 660YQ98I10
ANTIBACTERIALBENZALKONIUM CHLORIDE SOAPTopco Associates LLC463eafac-2367-3e5a-e063-6294a90a62932026-03-09Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
RENAFORCEBERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), COCCUS CACTI, KALI MURIATICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUMBioActive Nutritional, Inc.804b7055-e1e6-448d-8257-c562b971f4372026-03-09WarningsExact identifier
unii: 660YQ98I10
Gout Symptom ReliefAMMON PHOS, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA AND URTICA URENS.King Bio Inc.41dc03fc-169b-4691-bd62-9a41d7a6d2f72026-03-06WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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