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 65 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Schuessler Tissue Salts Kali Mur Glandular Tonic 5KALI MURIATICUMMartin & Pleasance Pty Ltd4b2d8d03-c829-4292-ad94-993376d81b8f2025-07-01WarningsExact identifier
unii: 660YQ98I10
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
unii: WQZ3G9PF0H
bolor sanitizing hand wipesBOLOR SANITIZING HAND WIPESEcoRhine LLC357e2190-5c43-86ba-e063-6294a90a97e62025-06-29WarningsExact identifier
unii: F5UM2KM3W7
BM Natural Mullein EarBELLADONNA, CALENDULA, ECHINACEA, HYDRASTIS, MULLEIN OIL, VIOLA ODORATABM Private Limited3890707a-d9b6-f1bd-e063-6394a90a33082025-06-27WarningsExact identifier
unii: C9TD27U172
unii: WQZ3G9PF0H
Cartilago BetulaCARTILAGO BETULAUriel Pharmacy Inc.8c1e84ed-63a7-430c-b25c-06eaddad456b2025-06-27WarningsExact identifier
unii: U0NQ8555JD
Rhus AconitumRHUS ACONITUMUriel Pharmacy Inc.a3ef433e-fca5-45dc-a972-b0021e048c532025-06-27WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
fomin mini Hand Sanitizer Wipes MELON POPBENZALKONIUM CHLORIDEFomin LLC080b6b55-ba4b-46a6-bcc2-914f906e05912025-06-24WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.38381a41-db33-45c6-e063-6394a90a23172025-06-23WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packagingb165ad93-1dc1-4863-9f0b-d7b97c42c94c2025-06-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
fomin mini Hand Sanitizer Wipes COCO-NILLA BLISSBENZALKONIUM CHLORIDEFomin LLC75a13584-a151-4fd4-a281-fec630801d652025-06-23WarningsExact identifier
unii: F5UM2KM3W7
fomin mini Hand Sanitizer Wipes FRAGRANCE FREEBENZALKONIUM CHLORIDEFomin LLC020f06c6-c76c-40fc-bc56-c11d5b389d672025-06-23WarningsExact identifier
unii: F5UM2KM3W7
Kindest Kare Advanced Antimicrobial Foam HandwashBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.9ea1175e-45aa-45c5-87a1-55d64cc37a882025-06-20WarningsExact identifier
unii: F5UM2KM3W7
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Cart Wipes Clean Sanitizing WipesBENZALKONIUM CHLORIDECarts and Parts INC.6a8433e8-7b96-44ce-b8e2-c60575898dab2025-06-18WarningsExact identifier
unii: F5UM2KM3W7
Sunshine YeastReliefVAGINAL YEAST RELIEFApcco Labs, Inc37de3347-7ad2-b9e7-e063-6394a90a90f42025-06-18WarningsExact identifier
unii: G0R4UBI2ZZ
FoamFresh Alco-Free Hand SanitizerBENZALKONIUM CHLORIDEWoodbine Products Company59614a1a-6b76-45e7-8b57-af307a1673cf2025-06-17WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx377854ff-8034-c7ac-e063-6294a90a08172025-06-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP32bc07dc-7a9c-63ed-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP33376694-fccd-6ed5-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3337b028-2291-0a1d-e054-00144ff88e882025-06-11WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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