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 19 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aterra7 Antibacterial Foaming Hand Fragrance FreeBENZALKONIUM CHLORIDEB4 Soap LLC25280f7c-9543-c4ff-e063-6394a90aee0f2026-04-01WarningsExact identifier
unii: F5UM2KM3W7
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: U0NQ8555JD
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCIProstat First Aid4cd5d67d-43d8-f6d2-e063-6394a90a40702026-03-31WarningsExact identifier
unii: F5UM2KM3W7
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: U0NQ8555JD
AddexLAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE, GLYPHOSATENutritional Specialties, Inc.50318603-4f2e-461a-8efb-98f3873836b92026-03-31WarningsExact identifier
unii: W2469WNO6U
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEAtlantic Biologicals Corp.4d7ad5c6-2c18-dc29-e063-6394a90a621e2026-03-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack9088ca44-5585-4551-8e2c-168f306520d42026-03-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Lymph Tonic IECHINACEA (ANGUSTIFOLIA), KALI IODATUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, HYPOPHYSIS SUIS, APIS MELLIFICA, ARANEA DIADEMA, BELLADONNA, CALCAREA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, GALIUM APARINE, GRAPHITES, LACHESIS MUTUS, MERCURIUS PRAECIPITATUS RUBER, MYRISTICA SEBIFERA, PHOSPHORUS, RHUS TOX, SCROPHULARIA NODOSA, SULPHUR, THYROIDINUM (SUIS), VESPA CRABROBioActive Nutritional, Inc.9b9a639c-0a91-48b5-b1ff-6b82c6a568ef2026-03-27WarningsExact identifier
unii: WQZ3G9PF0H
CerebraplexAVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, HYDROCOTYLE ASIATICA, POLYGONUM MULTIFLORUM, ROSMARINUS OFFICINALIS, VINCA MINOR, CEREBRUM SUIS, BARYTA CARBONICA, BELLADONNA, GERMANIUM SESQUIOXIDE, KALI PHOSPHORICUM, STRAMONIUMBioActive Nutritional, Inc.38905213-f20b-45d5-8e65-5f32e3839ea72026-03-27WarningsExact identifier
unii: WQZ3G9PF0H
El Valle MerthiolateBENZALKONIUM CHLORIDEPharmadel LLCfd7b28ca-9f71-0ff6-e053-6394a90a48222026-03-26WarningsExact identifier
unii: F5UM2KM3W7
Suave Antibacterial Hand Wash Fresh CitrusLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d77ec6-a1d1-13dc-e063-6394a90a95f42026-03-26WarningsExact identifier
unii: F5UM2KM3W7
Suave Antibacterial Hand Wash Deeply CleanLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d83736-66da-abb9-e063-6294a90a3d672026-03-26WarningsExact identifier
unii: F5UM2KM3W7
Suave Antibacterial Hand Wash Sea Minerals and Aloe VeraLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d8848c-d157-6e2c-e063-6294a90aa2592026-03-26WarningsExact identifier
unii: F5UM2KM3W7
Diabetic First Aid GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELavior Pharma Inc.bda875e6-06bd-930f-e053-2995a90ab1972026-03-26WarningsExact identifier
unii: F5UM2KM3W7
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: G0R4UBI2ZZ
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4dde3373-1c75-a815-e063-6294a90aa5572026-03-25WarningsExact identifier
unii: F5UM2KM3W7
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEAjenat Pharmaceuticals LLCab066a84-5455-419e-a1da-354a3f15a73d2026-03-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aterra7 Antibacterial Foaming HandBENZALKONIUM CHLORIDEB4 Soap LLCd53e3cad-f2b5-410c-b5a6-2d7bc86473d22026-03-23WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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