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 85 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foaming Sanitizing HandBENZALKONIUM CHLORIDEKutol Products Company95f0af0e-7889-4c2a-9573-4242acfd66842024-12-18WarningsExact identifier
unii: F5UM2KM3W7
Foaming Advanced Antibacterial HandBENZALKONIUM CHLORIDEKutol Products Company7abc56b5-4446-4464-9b94-6c55f8bb9b742024-12-18WarningsExact identifier
unii: F5UM2KM3W7
Foaming Antibacterial Hand Wash0.13% BENZALKONIUM CHLORIDERJ Schinner9cbbd5d5-02cb-7119-e053-2995a90a19052024-12-18WarningsExact identifier
unii: F5UM2KM3W7
E2 SANITIZING HANDE2 SANITIZING HANDKUTOL PRODUCTS COMPANY70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e2024-12-18WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
unii: F5UM2KM3W7
THROATCALMECHINACEA ANGUSTIFOLIA WHOLE, PLANTAGO MAJOR WHOLEBoironf5788da2-f60b-d0b8-e053-2995a90a11c72024-12-18WarningsExact identifier
unii: W2469WNO6U
DurashieldBENZALKONIUM CHLORIDEAdvanced Biomedical Incorporatedb0723781-225a-46c6-907c-5c5c48f383b82024-12-18WarningsExact identifier
unii: F5UM2KM3W7
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
unii: F5UM2KM3W7
SAN X E2BENZALKONIUM CHLORIDEAmerisan, LLCd6e2f275-4609-24e6-e053-2995a90a8dd32024-12-16WarningsExact identifier
unii: F5UM2KM3W7
KleenLine Essentials E2 Free and Clear Antibacterial HandSoapBENZALKONIUM CHLORIDEBrady Industries29681aee-d7a3-17e8-e063-6294a90a5ae92024-12-16WarningsExact identifier
unii: F5UM2KM3W7
KleenLine Essentials Antibacterial Foaming HandSoapBENZALKONIUM CHLORIDEBrady Industries2968ddad-598b-163b-e063-6294a90a57222024-12-16WarningsExact identifier
unii: F5UM2KM3W7
Soft Care Instant Hand Sanitizer AFBENZALKONIUM CHLORIDEDiversey, Inc.16846c69-b7e6-4ebe-b142-f1bf9b62c3282024-12-16WarningsExact identifier
unii: F5UM2KM3W7
Appeal Antibacterial Hand WashBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.357a4349-76f5-47b8-ae72-b1dbe19938862024-12-16WarningsExact identifier
unii: F5UM2KM3W7
SoftenSure Antimicrobial FoamBENZALKONIUM CHLORIDEBest Sanitizers, Inc29286676-a07f-78e3-e063-6294a90a4ac52024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Primory Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.3459ed2b-9440-4139-9262-f055d3980af72024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Mentholatum Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEThe Mentholatum Company365c93bc-2299-4e69-ba3a-69414bfe78d72024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Signatry Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.ab87b641-fdcd-4a64-8c38-f2def849a4312024-12-13WarningsExact identifier
unii: F5UM2KM3W7
PURELL Foodservice HEALTHY SP 0.5pct BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, Inc.a3061ef3-e4d7-49dd-b4cf-f71bf20dbfd22024-12-13WarningsExact identifier
unii: F5UM2KM3W7
PURELL Healthcare HEALTHY SP 0.5 BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, Inc.6f1b969e-77b9-46fd-8642-ffce87a73ecb2024-12-13WarningsExact identifier
unii: F5UM2KM3W7
GOJO Antibacterial Plum Foam Handwash with Biobased contentBENZALKONIUM CHLORIDEGOJO Industries, Inc.38abc40e-2f61-4436-9814-8586bf7d1acb2024-12-13WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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