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 134 of 134 · 2,668 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enuresis HP	ARGENTUM NITRICUM, BELLADONNA, CAUSTICUM, EQUISETUM HYEMALE, KREOSOTUM, NITRICUM ACIDUM, PULSATILLA (VULGARIS), THUJA OCCIDENTALIS	BioActive Nutritional, Inc.	a6fff9be-e78d-4539-b741-6a8080a164a0	2016-09-07	Warnings	Exact identifier unii: WQZ3G9PF0H
Sit Clean	BENZALKONIUM CHLORIDE	Sit Clean	ef2b12f8-89b3-47c4-88bd-8712a84cfc45	2016-08-18	Warnings	Exact identifier unii: F5UM2KM3W7
Thyrotox	CHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEA	BioActive Nutritional, Inc.	e229a260-13f3-4136-b325-9a8954f8a327	2016-08-10	Warnings	Exact identifier unii: WQZ3G9PF0H
Teething	ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA	BioActive Nutritional, Inc.	f39c9feb-f567-43a2-a026-2a581aeeed9d	2016-07-27	Warnings	Exact identifier unii: G0R4UBI2ZZ
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 660YQ98I10
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 660YQ98I10
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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