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 91 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
unii: F5UM2KM3W7
RageACONITUM NAPELLUS, ADRENALINUM, AGARICUS MUSCARIUS, APIS MELLIFICA, ATROPINUM, CAMPHORA, CANTHARIS, CAUSTICUM, CEREBRUM SUIS, CHAMOMILLA, CICUTA VIROSA, CUPRUM METALLICUM, HOMARUS, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, LAC CANINUM, MOSCHUS, STRAMONIUM, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.5cbc13c2-9dfb-4178-b539-06c940c3f4332024-11-06WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
unii: F5UM2KM3W7
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
unii: F5UM2KM3W7
Earache ReliefBELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)The Magni Company3f62001a-27b5-43cb-8006-110943facf872024-11-05WarningsExact identifier
unii: W2469WNO6U
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Altra Antimicrobial Foaming Hand Wash w/ Benzalkonium ChlorideBENZALKONIUM CHLORIDEBuckeye International, Inc.2618ecdc-3eeb-a69b-e063-6394a90a80242024-11-04WarningsExact identifier
unii: F5UM2KM3W7
Joint plus TendonACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, CARTILAGO SUIS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, RHUS TOX, THUJA OCCIDENTALISLiddell Laboratories, Inc.64465f12-f50e-46ef-bb82-9b10b18cfa242024-11-04WarningsExact identifier
unii: U0NQ8555JD
Bladder ToneBELLADONNA, CANTHARIS, CAUSTICUM, CINA, EQUISETUM HYEMALE, IGNATIA AMARA, PHYSALIS ALKEKENGI, PULSATILLA (PRATENSIS), SEPIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.4b64399b-31f8-418a-b27d-a0b7a05de5ec2024-11-04WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
OverwhelmedACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ANTIMONIUM CRUDUM, BARYTA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SILICATA, CICUTA VIROSA, CONIUM MACULATUMLiddell Laboratoriese32ada10-9458-46b9-ba01-9200f53d77182024-11-04WarningsExact identifier
unii: U0NQ8555JD
Tension HeadacheACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.6d49b251-bc9a-4383-a538-91d923e891482024-11-04WarningsExact identifier
unii: C9TD27U172
unii: U0NQ8555JD
Derma PainCALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)Liddell Laboratories, Inc.e02a5e99-aa27-4276-a785-7b5328d89fdc2024-11-04WarningsExact identifier
unii: W2469WNO6U
Nicotine FreeABIES NIGRA, ACONITUM NAPELLUS, AVENA SATIVA, CALADIUM SEGUINUM, IGNATIA AMARA, LOBELIA INFLATA, LUNG SUIS, NUX VOMICA, PLANTAGO MAJOR, QUEBRACHO, STICTA PULMONARIA, TABACUMLiddell Laboratories, Inc.11580c55-cfe8-42d5-b2f4-ab9141c380ad2024-11-04WarningsExact identifier
unii: W2469WNO6U
unii: U0NQ8555JD
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health Packaging96ea00f5-b922-4d57-b2ac-34523ea56d5f2024-10-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sanar Naturals MercurochromeBENZALKONIUM CHLOLRIDESanvall Enterprises, Inc16c6c2f0-0f08-e640-e063-6394a90aa01d2024-10-31WarningsExact identifier
unii: F5UM2KM3W7
VertitoneBAPTISIA TINCTORIA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, COCCULUS INDICUS, CONIUM MACULATUM, PHOSPHORUS, PULSATILLA (PRATENSIS)Energique, Inc.12f1c465-b64a-446c-a28c-e96dabe035802024-10-31WarningsExact identifier
unii: WQZ3G9PF0H
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial with Moisturizers Fresh Citrus LHSBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANYd824aedc-dba7-4259-bbec-9e3c28c6d8fb2024-10-30WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial Sparkling PearBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANY7fe1c0a1-11d5-443c-924a-652d62db7a062024-10-30WarningsExact identifier
unii: F5UM2KM3W7
RITE AID Maximum strength pain relievingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDERITE AIDc87671cb-d736-4ec6-ab10-94dff54925b22024-10-30WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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