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 36 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Anti-bacterial Hand Wipes Honey Wildflower ScentBENZALKONIUM CHLORIDEQuest USA Corpd5db76a3-871e-4110-afc3-80f84a77eb2b2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 WipesBENZALKONIUM CHLORIDEQUEST USA CORP.ae2fdb32-05c6-6d16-e053-2995a90a552d2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Pocket Size Singles Fresh Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corpd618e4fc-a37d-417f-8b4d-90bb31280cff2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: 660YQ98I10
hearingAESCULUS HIPPOCASTANUM, FLOS, CALC SULP, CALLUNA VULGARIS, FLOS, CLEMATIS VITALBA, FLOS, FER PHOS, KALI MUR, KALI SULPHSiddha Flower Essences LLCa239fd77-2687-45ad-a7c7-e9ffa15a635a2025-12-31WarningsExact identifier
unii: 660YQ98I10
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
unii: 660YQ98I10
WOUND WIPESBENZALKONIUM CHLORIDEHART Health4942195e-2941-4111-8ab7-2891c316bd272025-12-31WarningsExact identifier
unii: F5UM2KM3W7
MYSTIC FOAMING ANTI-BACTERIAL HANDSOAPBENZALKONIUM CHLORIDEEcolab Inc.5fe2b669-6a7a-49a5-8374-ad6298944e5c2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Advanced Antibacterial Foaming Hand SoapBENZALKONIUM CHLORIDEEcolab Inc.ea6d45ee-7713-4a90-81a8-6963c7f5c2302025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Clean ForceBENZALKONIUM CHLORIDEEcolab Inc.3f1ccba5-fc68-4e9b-8122-71b45dfa12822025-12-30WarningsExact identifier
unii: F5UM2KM3W7
PureForceBENZALKONIUM CHLORIDEEcolab Inc.4c2bcf98-a2c8-48ee-a3e0-e49cb667b27e2025-12-30WarningsExact identifier
unii: F5UM2KM3W7
EXP Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.468acf2d-97ff-4cac-91b1-067a1ea382f32025-12-30WarningsExact identifier
unii: F5UM2KM3W7
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Bio Biological DetoxECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PROPOLIS, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, THYMUS SERPYLLUM, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYROIDINUM (SUIS), BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, PYROGENIUM, ANTHRACINUM, ARSENICUM, CARBOLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, LACHESIS, VARIOLINUM, BOTULINUM, DYSENTERY BACILLUS, GAERTNER BACILLUS, FRANCISELLA TULARENSIS, COXIELLA BURNETII, LAC CANINUM, MALARIA OFFICINALIS,BioActive Nutritional, Inc.9a6671bb-b070-4f97-bdc0-189cf60407ee2025-12-30WarningsExact identifier
unii: WQZ3G9PF0H
FIRST MARK ULTRA FOAMING ANTIBACTERIALBENZALKONIUM CHLORIDEPerformance Food Group968c0f18-d0b6-4f29-b001-00ac314a3bdd2025-12-30WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.5b0701df-130b-49c4-8df6-101202e655ab2025-12-30WarningsExact identifier
unii: F5UM2KM3W7
tazza JIM WIPESBENZALKONIUM CHLORIDETazza Brands East, Inc.47008b6a-4882-d4a0-e063-6394a90ab85f2025-12-29WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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