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 98 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack80dd5de2-5066-472b-b1f8-88070a5c73882024-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Swisher TFBENZALKONIUM CHLORIDEEcolab Inc.d2ac8ef9-3426-4559-a8d3-6b6b5a638ef22024-08-05WarningsExact identifier
unii: F5UM2KM3W7
Clean ForceBENZALKONIUM CHLORIDEEcolab Inc.dc7bad8c-2e29-4d5d-b87e-8d9eae7c2c1c2024-08-02WarningsExact identifier
unii: F5UM2KM3W7
SwisherBENZALKONIUM CHLORIDEEcolab Inc.9f89f162-9816-4d33-aa25-0a70477250762024-08-02WarningsExact identifier
unii: F5UM2KM3W7
BronchiforceALTHAEA OFFICINALIS, LOBELIA INFLATA, RHEUM (PALMATUM), VERBASCUM THAPSUS, BELLADONNA, CUPRUM ACETICUM, DROSERA (ROTUNDIFOLIA), IPECACUANHA, SPONGIA TOSTA, STICTA PULMONARIABioActive Nutritional, Inc.fd1b5995-2334-4060-8cb2-f826eabac6b52024-08-02WarningsExact identifier
unii: C9TD27U172
Members MarkBENZALKONIUM CHLORIDEEcolab Inc.40342279-c73d-4644-8569-2b44982149e22024-08-02WarningsExact identifier
unii: F5UM2KM3W7
Equi-StatBENZALKONIUM CHLORIDEEcolab Inc.68e3174e-cb96-4739-a723-c36b2389f4f62024-08-02WarningsExact identifier
unii: F5UM2KM3W7
AVON footworks Maximum Strength Cracked HeelBENZALKONIUM CHLORIDE, LIDOCAINEThe Avon Company1f45752e-4a55-431e-e063-6294a90aa57a2024-08-01WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 377BENZALKONIUM CHLORIDEWhisk Products, Inc.2204c224-e12a-81c6-e063-6294a90a9fa42024-08-01WarningsExact identifier
unii: F5UM2KM3W7
FaciliproBENZALKONIUM CHLORIDEEcolab Inc.9948e401-6e5f-4d14-ad0b-f62735822c2a2024-08-01WarningsExact identifier
unii: F5UM2KM3W7
PureForceBENZALKONIUM CHLORIDEEcolab Inc.e624ea46-e502-4d2d-aaa1-59954f69be052024-08-01WarningsExact identifier
unii: F5UM2KM3W7
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMBioActive Nutritional, Inc.7920e8f6-be48-4402-9085-9673779db5a22024-07-31WarningsExact identifier
unii: 660YQ98I10
EcolabBENZALKONIUM CHLORIDEEcolab Inc.70516b96-5394-4f67-92c4-c50601c259462024-07-30WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.6860a80e-9a5f-40e4-bec3-e7386e541f5b2024-07-30WarningsExact identifier
unii: F5UM2KM3W7
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62cf-30ad-e053-2991aa0a19bd2024-07-23Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron8519dcba-d2e1-ffb8-e053-2a91aa0a7ada2024-07-23Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron851a3706-cc8c-b3f8-e053-2a91aa0ac0f52024-07-23Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron8519c019-9944-7c11-e053-2a91aa0afddd2024-07-23Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron85192110-5d56-59f7-e053-2a91aa0a48612024-07-23Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA RECUTITABoiron724d4680-7a53-11e6-b1ab-424c583030312024-07-23Exact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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