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 8 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non -Alcohol Cherry Scented Hand Sanitizer	BENZALKONIUM CHLORIDE	Shenzhen Lantern Scicence Co.,Ltd.	56b643ec-9433-9f19-e063-6294a90a5f22	2026-07-16	Warnings	Exact identifier unii: F5UM2KM3W7
Non -Alcohol Blueberry scented Hand sanitizer	BENZALKONIUM CHLORIDE	Shenzhen Lantern Scicence Co.,Ltd.	56b67ff4-5785-106e-e063-6294a90af4ec	2026-07-16	Warnings	Exact identifier unii: F5UM2KM3W7
Dove	MEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BAR	Conopco d/b/a Unilever	56bd6fcb-c762-4e5a-e063-6394a90a3438	2026-07-16	Warnings	Exact identifier unii: F5UM2KM3W7
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	H E B	56a72ebb-6037-12e4-e063-6294a90a34dc	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	H E B	56a7ea90-51d6-f366-e063-6294a90a8bbd	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56a8570f-caf4-627a-e063-6294a90a996f	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56a90a3e-1831-29f8-e063-6294a90a0874	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56a94b9d-8b38-6bd9-e063-6294a90ad14a	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56aa852a-2945-3ec8-e063-6394a90a4515	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56aad930-26cf-7f09-e063-6394a90a2a49	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56ab500f-83fe-f3d7-e063-6394a90a14b1	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56ab94e1-ef63-238a-e063-6394a90a5fdb	2026-07-15	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
Non -Alcohol Peach Scented Hand Sanitizer	BENZALKONIUM CHLORIDE	Shenzhen Lantern Scicence Co.,Ltd.	56b26868-833c-3d72-e063-6394a90aea4f	2026-07-15	Warnings	Exact identifier unii: F5UM2KM3W7
Leg Cramps PM	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR	Hyland's Inc.	b0574a7e-88fa-417e-b6d5-60ced59eba47	2026-07-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	6c080e51-4eb7-4e96-b29f-eb1cce381304	2026-07-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	H E B	56426ecd-e3e7-46df-e063-6394a90ab5cd	2026-07-10	Warnings, Adverse reactions	Exact identifier unii: F5UM2KM3W7
GOJO Antibacterial Plum Foam Handwash	BENZALKONIUM CHLORIDE	GOJO Industries, LLC	a485a02f-0f6a-45b2-af5b-f690e02637ec	2026-07-10	Warnings	Exact identifier unii: F5UM2KM3W7
Potassium Chloride	POTASSIUM CHLORIDE	ATLANTIC BIOLOGICALS CORP.	104ccc91-2aaf-4bb7-bb64-77c29413f60e	2026-07-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Antibacterial Hand Wipes Lil Drug Store	BENZALKONIUM CHLORIDE	Lil' Drug Store Products, Inc.	6ab0488c-02f3-4aa6-b6b3-d4f0d582b167	2026-07-10	Warnings	Exact identifier unii: F5UM2KM3W7
Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief	OLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALIS	Rida LLC	5c42c8ae-3610-4fc9-b764-ccf22340d9ce	2026-07-09	Warnings	Exact identifier unii: MJ95C3OH47

Reported adverse events (FAERS/openFDA)#

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