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 39 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibacterial Foam	BENZALKONIUM CHLORIDE	SC Johnson Professional USA Inc.	df36ccda-b9cb-41ba-8d4d-56ec447e63df	2025-12-23	Warnings	Exact identifier unii: F5UM2KM3W7
Antibacterial Liquid Hand	BENZALKONIUM CHLORIDE	Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.	ea0a5970-e95f-4090-bbe3-7df9e04393b5	2025-12-23	Warnings	Exact identifier unii: F5UM2KM3W7
MG DermaClean	N/A	Morgan Gallacher Inc.	ed3d983e-0a6e-4de4-832a-0020f7711011	2025-12-23	Warnings	Exact identifier unii: F5UM2KM3W7
MG DermaSan	N/A	Morgan Gallacher Inc.	d4c0de39-8570-4a05-a5e3-3752545ed95f	2025-12-23	Warnings	Exact identifier unii: F5UM2KM3W7
Crystal Clean Antibacterial HandSoap	BENZALKONIUM CHLORIDE	Chemcor Chemical Corporation	308969b5-5ab2-44ef-ac70-9518a5dfbee2	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Foaming Antibacterial Handsoap	BENZALKONIUM CHLORIDE	Chemcor Chemical Corporation	eed9b007-0dc1-4954-891f-a7a042e763aa	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Guardelle	BENZALKONIUM CHLORIDE	Social Medical Supply LLC	8793e3be-7409-4f71-9397-abbeacd27cf8	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Viru-Chord	BELLADONNA, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HEPAR SUIS, HYDRASTIS CANADENSIS, ILLICIUM ANISATUM, INFLUENZINUM, LACHESIS MUTUS, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MORBILLINUM, MYRRHA, NASTURTIUM AQUATICUM, NUX VOMICA, PALOONDO, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SAMBUCUS NIGRA, SCUTELLARIA LATERIFLORA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE)	Energetix Corporation	4a53b25e-f514-4d2d-8c2b-3c56d68ec7eb	2025-12-22	Warnings	Exact identifier unii: WQZ3G9PF0H
StellaLife VEGA Oral Care Peppermint Pain and Swelling Relief	ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIA	StellaLife, Inc.	10d42c12-713a-f461-e063-6294a90a223b	2025-12-22	Warnings	Exact identifier unii: G0R4UBI2ZZ
StellaLife VEGA Oral Care Coconut Advanced Healing Formula	AZADIRACHTA INDICA, APIS MELLIFICA, CALENDULA, ECHINACEA PURPUREA, OKOUBAKA AUBREVILLEI, PHOSPHOROUS, PLANTAGO MAJOR, STRONTIUM, THUJA OCCIDENTALIS	StellaLife, Inc.	10f6cd02-f80d-f597-e063-6294a90a09aa	2025-12-22	Warnings	Exact identifier unii: W2469WNO6U
StellaLife VEGA Oral Care Peppermint Advanced Healing Formula	AZADIRACHTA INDICA, CALENDULA, ECHINACEA PURPUREA, PLANTAGO MAJOR	StellaLife, Inc.	113ad845-3494-4bd1-e063-6294a90a40ae	2025-12-22	Warnings	Exact identifier unii: W2469WNO6U
StellaLife VEGA Oral Care Pain and Swelling Relief	ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA	StellaLife, Inc.	10f8dee1-d5d3-0602-e063-6294a90a6dbf	2025-12-22	Warnings	Exact identifier unii: G0R4UBI2ZZ
StellaLife VEGA Oral Care Cucumber Advanced Healing Formula	AZADIRACHTA INDICA, CALENDULA, ECHINACEA PURPUREA, PLANTAGO MAJOR	StellaLife, Inc.	1139fe05-886f-80d3-e063-6394a90a80e2	2025-12-22	Warnings	Exact identifier unii: W2469WNO6U
CareALL First Aid Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	New World Imports, Inc	69eef888-0044-485c-96a1-247ed1204858	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Antibacterial Handsoap	BENZALKONIUM CHLORIDE	Chemcor Chemical Corporation	1022be5e-d515-4a06-bf2b-65774ec29a0b	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Healthy Hands Foaming Hand Sanitizer	N/A	Maintex	746650b8-74b7-43f0-bdfc-62a68764f936	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Chemcor Chemical Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Chemcor Chemical Corporation	5c9d90c1-0381-4237-9529-398fa51b3ab4	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
Fresh Hands	BENZALKONIUM CHLORIDE	Maintex	e174083a-8820-4fa7-8cc2-0a2c86f27cd6	2025-12-22	Warnings	Exact identifier unii: F5UM2KM3W7
4 Kids Cold and Cough Nighttime Natural Grape Flavor	ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN	Hyland's Inc.	7923e59a-f62c-44df-e053-2991aa0afc1e	2025-12-19	Warnings	Exact identifier unii: G0R4UBI2ZZ
Sanitizing Wipes	BENZALKONIUM CHLORIDE	Wipes LLC	9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3	2025-12-19	Warnings	Exact identifier unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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