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 100 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial FoamSoapBENZALKONIUM CHLORIDEFerguson Enterprises18f9c948-74aa-ae19-e063-6294a90a23a12024-06-24WarningsExact identifier
unii: F5UM2KM3W7
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Nuvik Large Roll in Bucket Antibacterial Hand WipesBENZALKONIUM CHLORIDENuvik Usa, Inc.1f2035a1-0b8a-435e-a5ef-6ceda863fd372024-06-18WarningsExact identifier
unii: F5UM2KM3W7
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
unii: F5UM2KM3W7
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: W2469WNO6U
Three CleansingBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1ab25c0d-e616-30f7-e063-6294a90ad1e42024-06-12WarningsExact identifier
unii: F5UM2KM3W7
KALI MURKALI MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a3522bc-3d43-ea96-e063-6394a90aa2cc2024-06-06WarningsExact identifier
unii: 660YQ98I10
Antiseptic WipeBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1a3c5fc9-70cc-e857-e063-6294a90a34242024-06-06WarningsExact identifier
unii: F5UM2KM3W7
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, CICUTA VIROSA, OENANTHE CROCATA, CUPRUM METALLICUMNutritional Specialties, Inc.2f4acf3d-09d7-4dcc-b23c-793b0e2d53b12024-06-05WarningsExact identifier
unii: WQZ3G9PF0H
CHAMOMILLACHAMOMILLARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a0d7bbf-6779-7b67-e063-6394a90a1e5c2024-06-04WarningsExact identifier
unii: G0R4UBI2ZZ
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPc53d1db5-1c9e-4289-a2a2-961e0dd56f322024-06-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
BELLADONNABELLADONNARxhomeo Private Limited d.b.a. Rxhomeo, Inc19b9e2c4-120e-bf1b-e063-6294a90af7f62024-05-31WarningsExact identifier
unii: WQZ3G9PF0H
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUMNutritional Specialties, Inc.2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc2024-05-31WarningsExact identifier
unii: WQZ3G9PF0H
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7873638a-afd7-4b55-bcc5-0e893a437fb32024-05-31WarningsExact identifier
unii: F5UM2KM3W7
ACONITUM NAPACONITUM NAPRxhomeo Private Limited d.b.a. Rxhomeo, Inc191d539b-a231-b163-e063-6294a90a7d422024-05-23WarningsExact identifier
unii: U0NQ8555JD
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepackd396477a-6b15-4782-9c85-b9663b83c4842024-05-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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