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 38 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zep Tranq Mdw AB FoamBENZALKONIUM CHLORIDEZep Inc.5c3c1ab7-96a7-6ca5-e053-2991aa0af2b92025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ZEP PEAR AB HSBENZALKONIUM CHLORIDEZep Inc.5bc1cc32-5d18-00a8-e053-2991aa0a0c812025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL BERRY MEDLEYBENZALKONIUM CHLORIDEUniversal Distribution Center LLC0619a051-3f7d-4037-962c-e2e855a123422025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEBPI Labs LLCaeb2e14e-cd7c-49d0-a15f-fbbe89a03c6b2025-12-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
YELLOW ESSENTIALS SANITIZING WIPES87039-001Gritt Commercial Inc.3d403feb-0d15-d6cd-e063-6394a90a15e62025-12-25WarningsExact identifier
unii: F5UM2KM3W7
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: G0R4UBI2ZZ
potassium chloridePOTASSIUM CHLORIDERedpharm Drug3735d41a-7787-6b92-e063-6294a90add452025-12-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GoodEarth Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution LLC1c4ec3cb-b7a4-73c9-e063-6394a90afeda2025-12-24WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZERBENZALKONIUM CHLORIDETazza Brands East Inc.327b9971-808d-ff93-e063-6394a90adce42025-12-24WarningsExact identifier
unii: F5UM2KM3W7
CLEANZ ECO BAMBOO WIPESWIPESMcF Holdings LLCeb85292a-41a3-67b0-e053-2a95a90ab4612025-12-24WarningsExact identifier
unii: F5UM2KM3W7
ZEHN ANTISEPTIC SANITIZING WIPESBENZALKONIUM CHLORIDEZehn Wipes39771493-978e-18b6-e063-6294a90a42662025-12-24WarningsExact identifier
unii: F5UM2KM3W7
StellaLife VEGA Oral Care CoconutRISNEHomeocare Laboratories, Inc.b8c9c924-be3c-b100-e053-2a95a90a3fdc2025-12-24WarningsExact identifier
unii: W2469WNO6U
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: G0R4UBI2ZZ
StellaLife VEGA Oral CareSPRAYHomeocare Laboratories, Inc.46f3ff78-f5fc-6da1-e054-00144ff8d46c2025-12-24WarningsExact identifier
unii: W2469WNO6U
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
MG DermaFoamBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.4a43a605-f333-4c76-a476-476a9cc2e13a2025-12-23WarningsExact identifier
unii: F5UM2KM3W7
Sipa HAND SANITIZING WIPESBENZALKONIUM CHLORIDESipa Holdings USA, Inc.2c47f1a8-4416-fd21-e063-6394a90ae1672025-12-23WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZER KING WIPESBENZALKONIUM CHLORIDETazza Brands East, Inc.1c7d3d7b-64ca-4f91-e063-6294a90a04a72025-12-23WarningsExact identifier
unii: F5UM2KM3W7
StellaLife VEGA Oral Care CoconutRISNEStellaLife, Inc.b8694e38-dc05-77c9-e053-2995a90a36e42025-12-23WarningsExact identifier
unii: W2469WNO6U
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
unii: F5UM2KM3W7
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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