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
Label	Manufacturer	Effective date	Type
Ear Drops - Vitality Works, Inc.	Vitality Works, Inc.	2025-12-17	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-045-01	Earache Remedy	15 mL in 1 BOTTLE, DROPPER	LIQUID	15		10
64616-045-02	Earache Remedy	1 in 1 CARTON	LIQUID	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-045	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20241212_49afb2c3-ee42-4be9-943a-36d73ded0004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
PLANTAGO MAJOR	ACTIVE INGREDIENT	W2469WNO6U	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
VERBASCUM THAPSUS	ACTIVE INGREDIENT	C9TD27U172	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
PLANTAGO MAJOR	ACTIVE MOIETY	W2469WNO6U	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
VERBASCUM THAPSUS	ACTIVE MOIETY	C9TD27U172	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EARACHE 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 89 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FoamFresh E-2 Sanitizer Cleanser	BENZALKONIUM CHLORIDE	Woodbine Products Company	c49f49ad-06fc-4759-9ac9-1f1e29d8c2cf	2024-11-25	Warnings	Exact identifier unii: F5UM2KM3W7
E-2 Food Processing Foam Hand Wash	BENZALKONIUM CHLORIDE	Chemco Products Company	bbd70b29-c414-4baf-a50a-75aea213bdd4	2024-11-25	Warnings	Exact identifier unii: F5UM2KM3W7
Alcohol-Free Hand Sanitizing Foam	BENZALKONIUM CHLORIDE	United Laboratories Inc.	4f5ddead-1868-45c2-9657-762c9ca3a0e2	2024-11-25	Warnings	Exact identifier unii: F5UM2KM3W7
Transcend E2 Sanitizing Foam	BENZALKONIUM CHLORIDE	Von Drehle Corporation	bff148a6-02ec-6e86-e053-2995a90a5c9d	2024-11-25	Warnings	Exact identifier unii: F5UM2KM3W7
Harbor Mist E2 Sanitizing Foam with BZK	BENZALKONIUM CHLORIDE	Von Drehle Corporation	c3b710b5-cf40-0e09-e053-2a95a90a2173	2024-11-25	Warnings	Exact identifier unii: F5UM2KM3W7
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	2787f88c-752e-cbaa-e063-6394a90a732c	2024-11-21	Warnings	Exact identifier unii: U0NQ8555JD
BZK Antiseptic Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	d9f35c14-2f5a-4e1a-bc2b-a7e163134213	2024-11-21	Warnings	Exact identifier unii: F5UM2KM3W7
BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	1936d749-bf38-a433-e063-6294a90aba8c	2024-11-21	Warnings	Exact identifier unii: F5UM2KM3W7
BZK Antiseptic Wipe	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	673f2c21-d37e-41b1-af5e-471abbf2f914	2024-11-21	Warnings	Exact identifier unii: F5UM2KM3W7
Softsoap Antibacterial with Moisturizers White Tea and Berry	BENZALKONIUM CHLORIDE	COLGATE PALMOLIVE COMPANY	ee851610-5991-4dcc-a830-93edf6eb6097	2024-11-21	Warnings	Exact identifier unii: F5UM2KM3W7
Hempvana Ultra Pain Relief - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	f93a1ed0-5046-0355-e053-6294a90a6a90	2024-11-20	Warnings	Exact identifier unii: U0NQ8555JD
Pet wipes	BENZALKONIUM CHLORIDE	Shandong Yayun Sanitary Products Co., Ltd.	2764ea79-32d8-b7f6-e063-6394a90a5501	2024-11-20	Warnings	Exact identifier unii: F5UM2KM3W7
Dial refresh and renew Antibacterial Bar Spring Water	BENZALKONIUM CHLORIDE	Henkel Corporation	f8390069-3899-908f-e053-6294a90ad2fb	2024-11-20	Warnings	Exact identifier unii: F5UM2KM3W7
Potassium Chloride	POTASSIUM CHLORIDE	PAI Holdings, LLC dba PAI Pharma	e848477f-b10d-4249-b322-b70cd6a062de	2024-11-19	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
North Woods Derma Foam E-2	BENZALKONIUM CHLORIDE	Superior Chemical Corporation	ab982dec-639a-277a-e053-2a95a90ac8b4	2024-11-18	Warnings	Exact identifier unii: F5UM2KM3W7
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	3a720078-f455-44ab-a883-e3c13d83a74c	2024-11-18	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
MARVEL BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	93ed0bb4-834d-44ca-9c0a-20086fc09ab8	2024-11-18	Warnings	Exact identifier unii: F5UM2KM3W7
potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	cf014023-5300-455f-9f7f-fefb2e363986	2024-11-18	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
First Aid Only First Aid/Burn	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Acme United Corporation	caa67a05-bdbd-c380-e053-2995a90a0bf1	2024-11-17	Warnings	Exact identifier unii: F5UM2KM3W7
Altra Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloe	BENZALKONIUM CHLORIDE	Buckeye International, Inc.	a35ad6ce-700c-5b42-e053-2995a90a7da6	2024-11-15	Warnings	Exact identifier unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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