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 43 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ring Relief PM Nighttime Formula	ARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREA	TRP Company	92ef0dd1-84f9-086c-e053-2a95a90ac647	2025-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Swimmers Ear Complete Relief	CALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIAN	TRP Company	a3425da3-ace9-05c2-e053-2995a90ab09f	2025-12-15	Warnings	Exact identifier unii: 660YQ98I10
Respo-K	CALC SULPH, FERRUM PHOS, HEPAR SULPH CALC, SAMBUCUS NIG, VERBASCUM	SILVER STAR BRANDS	b727168c-0cb3-6a6a-e053-2995a90a0af0	2025-12-12	Warnings	Exact identifier unii: C9TD27U172
Orajel 4X Medicated For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999851ac-925c-7d1f-e053-2a95a90a240b	2025-12-12	Warnings	Exact identifier unii: F5UM2KM3W7
Orajel 4X Medicated For Toothache and Gum, Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999aa7b9-bf9e-9285-e053-2a95a90a345b	2025-12-12	Warnings	Exact identifier unii: F5UM2KM3W7
Orajel 4X Medicated PM For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999cff2b-c23e-5abe-e053-2a95a90a7569	2025-12-12	Warnings	Exact identifier unii: F5UM2KM3W7
AmazaPet	ALTHAEA, ARSENICUM ALB, INULA, KALI MUR, MAG PHOS	SILVER STAR BRANDS	b724bc91-d3e1-290e-e053-2a95a90a2625	2025-12-12	Warnings	Exact identifier unii: 660YQ98I10
GERM HP	APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE	Natural Creations, Inc.	15dc5391-0e6e-45d9-8ac7-142333a90716	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Germasode	ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRA	Natural Creations, Inc	cad24325-e658-4427-a2e7-f821f0111170	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H
GBLV HP	ATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, VERATRUM ALBUM ROOT	Natural Creations, Inc.	cff4d830-6696-4cde-9cd7-4ce55e28b54b	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H
BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry Berry	BENZALKONIUM CHLORIDE	KAS Direct LLC dba BabyGanics	75ae3b5e-b583-4b80-b4ab-5cc40978ca30	2025-12-12	Warnings	Exact identifier unii: F5UM2KM3W7
HEADACHE HP	SILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIA	Natural Creations, Inc.	c38b83f0-3918-4ef6-8dfd-48fe438e584a	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H
Cell Well	CALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA	JoyWell Co LLC	592c1f48-21c8-4ff5-8818-046662c9effe	2025-12-11	Warnings	Exact identifier unii: 660YQ98I10
Throat Remedy	BELLADONNA 30C, HEAR SULPHURIS CALCAREUM 30C, LACHESIS MUTUS 30C, MERCURIUS SOLUBILIS 30C, PHYTOLACCA DECANDRA 30C, FERRUM PHOSPHORICUM 6X, KALI MURIATICUM 5X, CALCAREA SULPHURICA 6X, STREPTOCOCCINUM 200C	JoyWell Co LLC	51c00f80-3642-4552-a0f8-02a0f7495cf8	2025-12-11	Warnings	Exact identifier unii: 660YQ98I10 unii: WQZ3G9PF0H
Dial Antibacterial Vitamin Bar	DIAL ANTIBACTERIAL VITAMIN BAR SOAP	Henkel Corporation	292bf620-5cde-388d-e063-6394a90a307c	2025-12-11	Warnings	Exact identifier unii: F5UM2KM3W7
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	ATLANTIC BIOLOGICALS CORP.	dc55474c-cc51-4f17-8cb3-0f34b3e68a55	2025-12-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bright Amber Antibacterial	BENZALKONIUM CHLORIDE	Colgate-Palmolive Company	44f9cf18-dd2d-4637-a5e1-3db82a1904ff	2025-12-11	Warnings	Exact identifier unii: F5UM2KM3W7
FLU HP	ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS ROOT	Natural Creations, Inc.	3d6c203a-6f30-4417-84d3-3cdab22098e3	2025-12-10	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
HurriCaine One	TOPICAL ANESTHETIC AND ANTISEPTIC	Beutlich Pharmaceuticals LLC	459cedbd-9b6f-e450-e063-6394a90afb73	2025-12-10	Warnings	Exact identifier unii: F5UM2KM3W7
DIARRHEA CP	AETHUSA CYNAPIUM, ARSENIC TRIOXIDE, OYSTER SHELL CALICUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLOBILIS, PHOSPHORUS, PODOPHYLLUM, ANEMONE PULSATILLA, DELPHINIUM STRAPHISAGRIA SEED, SULFUR	Natural Creations, Inc.	06f51c41-1e76-4201-937a-cbaaf6a477af	2025-12-10	Warnings	Exact identifier unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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