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 84 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Gel Oral Pain Relief	BENZOCAINE BENZALKONIUM CHLORIDE	Savvy Care and Cosmetics	05ede7e4-5a0a-c942-e063-6294a90a8a24	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
AFFEX Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Afflink, Inc.	3f51700a-0e8f-4091-ab0d-6751364304a4	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
PRIME SOURCE Antibacterial Foam Handwash	BENZALKONIUM CHLORIDE	BUNZL	eb626be7-baec-447c-97e1-534494beb020	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
PRIME SOURCE SELECT Plum Antibacterial Foam Hand So ap	BENZALKONIUM CHLORIDE	BUNZL	d56dbf55-9630-4d00-9dc5-68e55f48e793	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
DON Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Edward Don & Company	5b6852cd-b45a-4262-b454-041f223fa3f8	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
PRIME SOURCE ULTRA Energy Plum Antibacterial Foam Hand So ap	BENZALKONIUM CHLORIDE	BUNZL	fdb354e7-564f-4b0e-8bb7-789552198818	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
RENOWN Antibacterial Plum Handwash	BENZALKONIUM CHLORIDE	Interline Brands, Inc.	2b876c51-358a-4bb2-8f35-317ed7af4740	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Victoria Bay Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Dade Paper & Bag, LLC	51d05dca-ffe4-4f1c-a883-43c436dbf740	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
BRIGHT SOLUTIONS Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Kel-San, Inc.	844a80f3-9fd5-4688-81c8-494eb11a024a	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Pro Formance Plum Perfection Antibacterial Foam S oap	BENZALKONIUM CHLORIDE	Pro-Link, Inc.	6bdc6f78-5ecd-4de7-9457-eda580c3a3e0	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
PRO-LINK Antibacterial Plum Perfection Foam So ap	BENZALKONIUM CHLORIDE	Pro-Link, Inc.	f1d7ff55-2b95-44a7-86dd-8e6f39ed7cf5	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
SMART Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Southeastern Paper Group, Inc.	9cb5d5df-9f41-4e19-b937-b983bfdf737c	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
EXTENDED CARE Antimicrobial Plum Foam Handwash	BENZALKONIUM CHLORIDE	TRIPLE A SUPPLIES, INC.	8edc666c-1d7d-4f9e-8a30-2e9fbf43209a	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
BRIGHTON PROFESSIONAL Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Staples	845f4281-408c-47b4-bbf0-4f248deadc35	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Elevate TF Foam Skin Care Advance Antibacterial Foam Hand Cleaner	BENZALKONIUM CHLORIDE	Triple S a.k.a Standardized Sanitation Systems, Inc	7d031478-17b8-4cca-b04e-e63970c20bcc	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Reliable Luxury Foam Antimicrobial Handwash Citrus Floral Scent	BENZALKONIUM CHLORIDE	Veritiv Operating Company	b5a5e487-dc83-4ae2-b508-346b4dc8ceb1	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	Waxie Sanitary Supply	2b7b7d69-02e3-4d2e-a088-60189fe31b4c	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Reliable Hand So ap Antibacterial Plum	BENZALKONIUM CHLORIDE	Veritiv Operating Company	4f6bfbda-099f-4c8e-863f-e506357f940a	2024-12-19	Warnings	Exact identifier unii: F5UM2KM3W7
Trace Mineral Cord	ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,	Energique, Inc.	902dd68d-5ce1-481e-8938-6487dcc68dfc	2024-12-19	Warnings	Exact identifier unii: 660YQ98I10
Instant Foam Non-alcohol PURE Hand Sanitizer	BENZALKONIUM CHLORIDE	SC Johnson Professional USA, Inc.	fc557f8d-7ebe-4434-a350-602efbbb9c6e	2024-12-18	Warnings	Exact identifier unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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