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 68 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airway EaseINFLUENZINUM, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB., KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA.Newton Laboratories, Inc.969d473d-4d59-6345-e053-2995a90a6c492025-05-07WarningsExact identifier
unii: C9TD27U172
Airway EaseINFLUENZINUM, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB., KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA.Newton Laboratories, Inc.96b282c0-002b-7363-e053-2a95a90acd972025-05-07WarningsExact identifier
unii: C9TD27U172
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2024-2025), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.ac036ad8-6f48-4c15-b021-dc9bbb7e642e2025-05-06WarningsExact identifier
unii: U0NQ8555JD
Foamy BlueBENZALKONIUM CHLORIDEPro Chem Solutions, Inc.aafecb36-082a-4577-a06a-4a5460e21a1d2025-05-05WarningsExact identifier
unii: F5UM2KM3W7
Potassium ChloridePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCa230185f-5493-487d-892a-5219869b4e472025-05-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
bolor sanitizing hand wipesBOLOR SANITIZING HAND WIPESEcoRhine LLC33ea380c-5a71-6482-e063-6394a90a53e52025-05-04WarningsExact identifier
unii: F5UM2KM3W7
bolor sanitizing hand wipesBOLOR SANITIZING HAND WIPESGuangzhou Baihua Co., Ltd33dbe9e3-4335-ada1-e063-6294a90ad2f52025-05-04WarningsExact identifier
unii: F5UM2KM3W7
WIPESPLUS HAND SANITIZING ALCOHOL FREE WIPESBENZALKONIUM CHLORIDECFS Brands3400d7c2-b72b-c602-e063-6294a90a12302025-04-30WarningsExact identifier
unii: F5UM2KM3W7
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: WQZ3G9PF0H
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepackab147ac2-d7d5-46d1-a2de-d866219197c12025-04-28Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
FaciliproBENZALKONIUM CHLORIDEEcolab Inc.59580c40-ca37-4ac9-a2c3-ea86197cf68c2025-04-21WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
unii: F5UM2KM3W7
Childrens Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.32ece9d6-b346-6304-e063-6394a90a182d2025-04-16WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
COLDCALMONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoironda32d4e3-f049-e7c8-e053-2a95a90a57902025-04-15WarningsExact identifier
unii: WQZ3G9PF0H
Aire-Master Antibacterial FoamBENZALKONIUM CHLORIDEWhisk Products, Inc.d3efefdd-46d1-48dc-899c-e85b9eee08822025-04-15WarningsExact identifier
unii: F5UM2KM3W7
Be Smart Get Prepared Antiseptic WipeBENZALKONIUM CHLORIDETotal Resources International, Incf2151af3-d76a-490f-90ff-728c350fe1682025-04-11WarningsExact identifier
unii: F5UM2KM3W7
Umcka Fastactv BerryPELARGONUIM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS, BRYONIA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, ALPHA CFProSolutions Inceedab4b9-509b-3fe5-e053-2995a90a20272025-04-10WarningsExact identifier
unii: U0NQ8555JD
Bestmade Natural Products BM13 PelletsBELLADONNA, CUPRUM ACETICUM, DROSERA , GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTABestmade Natural Products3241a46c-d3ce-08be-e063-6294a90af2ee2025-04-08WarningsExact identifier
unii: WQZ3G9PF0H
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
unii: F5UM2KM3W7
Chamomilla 7XMATRICARIA RECUTITATrue Botanica, LLC227daf6d-95e6-b320-e063-6394a90a10c02025-04-07WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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