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 42 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PS-2205 BZK Antiseptic Towelettes	PS-2205 BZK ANTISEPTIC TOWELETTES	ProStat First Aid LLC	00772636-8265-a937-e063-6294a90a438a	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480bd260-3893-56e6-e054-00144ff8d46c	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
First Aid Burn Cream	FIRST AID BURN CREAM	ProStat First Aid LLC	0037a1a4-d747-2567-e063-6394a90a721c	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
2677 First Aid Burn Cream	2677 FIRST AID BURN CREAM	ProStat First Aid LLC	ff5bb628-8ef7-4540-e053-6394a90a55ed	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
Antiseptic Wipes	ANTISEPTIC WIPES	ProStat First Aid LLC	0e120fed-3225-520b-e063-6394a90a9f9e	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
Childrens First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480e73ed-b79e-6ada-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Antiseptic Wipes	ANTISEPTIC WIPES	Front Line Safety	0e1f3653-d75e-9c9e-e063-6294a90ab639	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
Antiseptic Wipes	ANTISEPTIC WIPES	ProStat First Aid LLC	0e11238b-e5f2-075f-e063-6394a90aa825	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
First Aid Burn Cream	FIRST AID BURN CREAM	Front Line Safety	0f4ce2c2-f306-d95f-e063-6394a90ae7b3	2025-12-15	Warnings	Exact identifier unii: F5UM2KM3W7
EarAche Relief	APIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, TRIBASIC CALCIUM PHOSPHATE, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, MERCURIUS SOLUBILIS	TRP Company	e7813a36-4d1f-465e-9b76-1ab6b9f5b96f	2025-12-15	Warnings	Exact identifier unii: WQZ3G9PF0H
Animal First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	84628a32-7328-b71d-e053-2991aa0ae673	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Poultry First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	8464d4d1-6814-202f-e053-2991aa0a576b	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Skin Repair	ROSA CANINA, MATRICARIA RECUTITA, ARCHILLEA MILLEFOLIUM	Spry Life LLC	7bd56d39-83d0-3d55-e053-2a91aa0a571a	2025-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Cold Sore Relief	STELLARIA MEDIA, SALVIA OFFICINALIS, CALENDULA OFFICIALS, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	408119cb-6865-0b1b-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Foot Care	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480e32e4-42d1-606c-e054-00144ff8d46c	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
EarAche Relief PM	APIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALIS	TRP Company	92ee4f15-7315-7a46-e053-2995a90a7d0a	2025-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Poison Ivy Care	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480ee4ba-a92c-07ee-e054-00144ff8d46c	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Migraine Headache Therapy	ATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -	TRP Company	317d3f42-783e-02b7-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: WQZ3G9PF0H
Salvacine	CALENDULA OFFICIALS, PLANTAGO MAJOR, OLEA EUROPAEA, ACHILLEA MILLEFOLIUM	Spry Life LLC	e76594d6-7397-5d57-e053-2a95a90a99af	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U unii: MJ95C3OH47
Tattoo Care	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480f0858-1f69-057c-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U

Reported adverse events (FAERS/openFDA)#

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