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 103 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Inverness Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	0ccd72e7-16a2-47c7-9ce6-dffb63a0344b	2024-04-18	Warnings	Exact identifier unii: F5UM2KM3W7
Lovisa Piercing Care Solution	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	74f46b81-cc5b-4e3f-a36e-0bd86d370c22	2024-04-18	Warnings	Exact identifier unii: F5UM2KM3W7
CliniClean BZK Cleansing Contains Benzalkonium Chloride	BENZALKONIUM CHLORIDE	HR HealthCare	b6916466-0931-408f-a430-0797a449c32e	2024-04-18	Warnings	Exact identifier unii: F5UM2KM3W7
Quality Choice Oral Pain Relief	BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	162702b4-4bf7-8868-e063-6294a90a5921	2024-04-15	Warnings	Exact identifier unii: F5UM2KM3W7
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Bryant Ranch Prepack	65e30d1a-50e9-4b84-ad4d-daaea91eab4b	2024-04-09	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Female Support	CHAMOMILLA, CIMICIFUGA RACEMOSA, HELONIAS DIOICA, MENTHA PIPERITA, SENNA (CASSIA ANGUSTIFOLIA), VALERIANA OFFICINALIS, VIOLA ODORATA, AGNUS CASTUS, LEDUM PALUSTRE, LILIUM TIGRINUM, STAPHYSAGRIA, CROCUS SATIVUS, HYDRASTIS CANADENSIS, CINCHONA OFFICINALIS, CONVALLARIA MAJALIS, CYCLAMEN EUROPAEUM, CINNAMOMUM, MUREX PURPUREA, NAJA TRIPUDIANS	Deseret Biologicals, Inc.	08e9d17b-9212-4822-9264-a15aa3a9c032	2024-04-04	Warnings	Exact identifier unii: G0R4UBI2ZZ
BZK	BENZALKONIUM CHLORIDE	Henry Schein Inc.	ff877b63-fa58-4770-a882-694eda33203b	2024-04-02	Warnings	Exact identifier unii: F5UM2KM3W7
SINU HC	PLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUM	Deseret Biologicals, Inc.	8b63e066-dd1b-4aee-a17b-4edc6b71a1cc	2024-04-02	Warnings	Exact identifier unii: W2469WNO6U
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	8e1f35ff-d4e6-4940-ad8f-dce2b73e595d	2024-04-01	Warnings	Exact identifier unii: F5UM2KM3W7
Antiseptic Towelette TOALLITAS ANTISEPTICAS	BENZALKONIUM CHLORIDE	M-star (Hubei) Health&Care Products Co., Ltd.	b267e186-cf7a-458f-9c28-a48a8554af40	2024-04-01	Warnings	Exact identifier unii: F5UM2KM3W7
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
Oral Health	ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,	Deseret Biologicals, Inc.	6f66ff40-6e0e-4a35-963c-965c65df76eb	2024-04-01	Warnings	Exact identifier unii: 660YQ98I10 unii: G0R4UBI2ZZ
DigiSan E	BENZALKONIUM CHLORIDE	Ecolab Inc.	bf0f0e43-953f-4a5c-a529-85bb31019b6f	2024-03-28	Warnings	Exact identifier unii: F5UM2KM3W7
PNEUMOPLEX	PLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHUR	BioActive Nutritional, Inc.	d839aea1-7725-40c1-b000-228843f75b93	2024-03-26	Warnings	Exact identifier unii: W2469WNO6U
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	59ccc717-c374-41c0-be58-9647df881160	2024-03-26	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Lymphastat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUM	Energique, Inc.	95406534-526e-4bca-b73d-1030623549a3	2024-03-26	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
ULINE Eyewash	EYEWASH	Uline.	14545fc9-1fb4-befa-e063-6294a90a0474	2024-03-23	Warnings	Exact identifier unii: 059QF0KO0R
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	7c5cc705-e5da-4487-86c9-9d545a95afb4	2024-03-22	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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