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 87 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alpet Q E2BENZALKONIUM CHLORIDEBest Sanitizers, Incb5701ea7-60a8-4dcd-8a32-42029960c5592024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ALPET QE2 SANITIZING FOAMBENZALKONIUM CHLORIDEBest Sanitizers, Inc.0aa71f9d-f660-4a32-b54a-1968aea9d0ee2024-12-05WarningsExact identifier
unii: F5UM2KM3W7
HACCP Q E2 SanitizingBENZALKONIUM CHLORIDEBest Sanitizers, Inc.b5f48d59-8062-4b72-b87d-5825a519f5f92024-12-05WarningsExact identifier
unii: F5UM2KM3W7
HACCP QE2BENZALKONIUM CHLORIDEBest Sanitizers, Inc0b861f72-f93e-40d6-9967-43e5f6b7c1282024-12-05WarningsExact identifier
unii: F5UM2KM3W7
OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.615921dd-46e5-403c-9ed3-f30beb0c0bb92024-12-05WarningsExact identifier
unii: F5UM2KM3W7
BLACK OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d3366750-18b8-1194-e053-2995a90a43592024-12-05WarningsExact identifier
unii: F5UM2KM3W7
BLACK OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d335bf6d-dc75-bd80-e053-2a95a90abb562024-12-05WarningsExact identifier
unii: F5UM2KM3W7
OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d4c65a93-832a-6a8b-e053-2a95a90a77b82024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH BERRY MEDLEYBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747b366d-4854-52e8-e053-2a91aa0a67592024-12-05WarningsExact identifier
unii: F5UM2KM3W7
antiseptic towelette 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.e9f2a1f1-ceb6-2f20-e053-2a95a90a18db2024-12-04WarningsExact identifier
unii: F5UM2KM3W7
PURELL HEALTHY SP BAK E2 Antimicrobial Foam SpBENZALKONIUM CHLORIDEGOJO Industries, Inc.4ea02d8a-cb03-4e9e-b63d-72b83fa816f82024-12-03WarningsExact identifier
unii: F5UM2KM3W7
GOJO E2 Foam Handwash with BAKBENZALKONIUM CHLORIDEGOJO Industries, Inc.f18732bd-65c7-4e11-b364-054b7e7425052024-12-03WarningsExact identifier
unii: F5UM2KM3W7
Cough and Cold ReliefARG MET, ARSENICUM ALB, BAPTISIA, BRYONIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, MERC COROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VALSilver Star Brands9d4a851c-ebda-1918-e053-2995a90a49362024-12-03WarningsExact identifier
unii: 660YQ98I10
SciatiGon-MACONITUM NAPELLUS, BERBERIS VULGARIS, CHAMOMILLA, COLOCYNTHIS, MAGNESIA PHOSPHORICA, RHUS TOXSilver Star Brands8c175b30-07e2-157c-e053-2a95a90ac92f2024-12-03WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: U0NQ8555JD
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: U0NQ8555JD
Aquabain Antibacterial Passion BerrysBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.aee5d7c2-93b3-f55e-e053-2995a90af72e2024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Aquabain Antibacterial Fresh and RelaxBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d3086-7902-2837-e053-2995a90a39df2024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Aquabain Antibacterial GrapefruitBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f49-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Aquabain Antibacterial Red FruitsBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f4d-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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