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 64 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Club Wipes Alcohol Free Antimicrobial Cleaning WipesBENZALKONIUM CHLORIDEPetra Hygienic Systems Int Ltd141b9ea3-8d98-4c3c-9c15-31b84a3a7f642025-07-17WarningsExact identifier
unii: F5UM2KM3W7
CLUB Wipes Sanitizing Wipes for HandsBENZALKONIUM CHLORIDEPetra Hygienic Systems International Limited5d8a5da7-d113-41f0-b703-84e5a9b860072025-07-17WarningsExact identifier
unii: F5UM2KM3W7
Petra Health E Wipes Alcohol Free AntisepticBENZALKONIUM CHLORIDEPetra Hygienic Systems Int Ltd8d518c8e-7c16-4df8-af18-34f39b81624f2025-07-17WarningsExact identifier
unii: F5UM2KM3W7
Good to Go Antibacterial Hand WipesBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.3a243ef5-2a23-4393-e063-6294a90a2bf92025-07-17WarningsExact identifier
unii: F5UM2KM3W7
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
unii: F5UM2KM3W7
Potassium chloridePOTASSIUM CHLORIDECamber Pharmaceuticals, Inc.fb2f6e74-4c1f-40c5-88a1-b88c069d4c752025-07-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
X3 Clean Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.5a0aea16-b1ff-4fa1-a292-0f14474745932025-07-15WarningsExact identifier
unii: F5UM2KM3W7
potassium chloridePOTASSIUM CHLORIDESolco Healthcare LLC52d91d76-8c7f-40f1-9f5c-e05962cabedd2025-07-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Smart Care ANTIBACTERIAL HAND SANITIZING WIPES FRESH SCENTBENZALKONIUM CHLORIDEAshtel Studios, Inc.a805781b-c28e-4559-9b83-ea39dc51a03b2025-07-15WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC616f0de7-8843-44a1-8fa6-274d889286aa2025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KLOR-CONPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC1ff53330-065c-4213-9c0c-ac498621d09d2025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KLOR-CONPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCe61a4522-b91d-400a-952c-6f035e4610dd2025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KLOR-CON MPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCb89910f6-4ff5-4a62-8269-696f7c10e4f62025-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39904847-ed55-f4a3-e063-6294a90a85a12025-07-10WarningsExact identifier
unii: F5UM2KM3W7
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.397a897a-baab-d209-e063-6294a90aac652025-07-10WarningsExact identifier
unii: F5UM2KM3W7
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.398fd961-d5e6-9d40-e063-6294a90a5be52025-07-10WarningsExact identifier
unii: F5UM2KM3W7
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39901012-e1a1-c6e3-e063-6294a90ab41f2025-07-10WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEUpsher-SmithLaboratories, LLCad584ce4-a64d-4851-80e9-0eeedc0b9d062025-07-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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