NDC 64616-050-01 - Pediatric 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: 64616-050
Requested NDC: 64616-050-01
Package NDCs from labels: 64616-050-01, 64616-050-02
Manufacturer: Vitality Works, Inc | 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.	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
64616-050-01	Pediatric Earache Remedy	15 mL in 1 BOTTLE, DROPPER	LIQUID	15		9
64616-050-02	Pediatric Earache Remedy	1 in 1 CARTON	LIQUID	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-050	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	8	Current NDC, Legacy NDC, 2 package rows	20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
PLANTAGO MAJOR	ACTIVE INGREDIENT	W2469WNO6U	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
VERBASCUM THAPSUS	ACTIVE INGREDIENT	C9TD27U172	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
PLANTAGO MAJOR	ACTIVE MOIETY	W2469WNO6U	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
VERBASCUM THAPSUS	ACTIVE MOIETY	C9TD27U172	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1

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 11 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dermveda NAIL FUNGUS SERUM	OLIVE EXTRACT, SULFUR	Celcius Corp.	6d999dac-7b84-4f19-957e-5c787a4e96c4	2026-02-09	Warnings	Exact identifier unii: MJ95C3OH47
dermveda SCABIES ITCH RELIEF SERUM	OLIVE EXTRACT, SULFUR	Celcius Corp.	86a8bffd-81a8-4f22-89b6-e51158f336db	2026-02-09	Warnings	Exact identifier unii: MJ95C3OH47
dermveda JOCK ITCH	OLIVE EXTRACT, SULFUR	Celcius Corp.	252ed439-0e4c-419f-8b34-d1b52da8464f	2026-02-06	Warnings	Exact identifier unii: MJ95C3OH47
DPT-TOX	DROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJA	Nutrition Center Inc dba Nutri-West dba Micro-West	5e39f4e6-939f-4b71-9cc5-6d4b8711ea32	2026-02-04	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	5c2e888c-2f1e-4d5a-a456-20774ca83302	2026-02-04	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Major Pharmaceuticals	7d74652b-3513-4ebb-8b47-10b3603d04a7	2026-02-04	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
NerveFix	ACONITUM NAPELLUS, BELLADONNA, CANTHARIS, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, HYPERICUM PERFORATUM, SPIGELIA ANTHELMIA	NaturalCare	92326b54-cac9-4fb2-ae48-120a0dcbbe56	2026-02-03	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Cough and Mucus Night	ANTIMONIUM TARTARICUM, AVENA SATIVA, BRYONIA (ALBA), CHAMOMILLA, DROSERA (ROTUNDIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, STANNUM METALLICUM, SULPHUR	NaturalCare	f27e3a7f-78a3-4003-95fc-0b32671df443	2026-02-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Rising Pharma Holdings, Inc.	947c11ca-ca0c-42df-8cc5-3db06458ca5b	2026-02-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
SUTAB	SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE	Azurity Pharmaceuticals, Inc.	c020e973-dccf-4862-999e-17db6209a48a	2026-01-31	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
OHM-RESB	ACONITUM, ARANEA, BRYONIA, EQUISETUM, EUPATORIUM PERF, HYDRASTIS, JUGLANS REG, KALI BIC, PHOSPHORUS, SARSAPARRILLA, SULPHUR	OHM PHARMA INC.	49e4b472-9ac3-465e-acfa-8879939ce7b4	2026-01-28	Warnings	Exact identifier unii: U0NQ8555JD
NeoRelief for Menstrual Pain and Cramps	HOMEOPATHIC PAIN RELIEF GEL	BioLyte Laboratories, LLC	71c2a2f7-4823-51cb-e053-2995a90a5fb8	2026-01-27	Warnings	Exact identifier unii: WQZ3G9PF0H
Contessa	ALCHEMILLA VULGARIS, ASPERULA ODORATA, CHAMOMILLA, VIOLA ODORATA, CINCHONA OFFICINALIS, MENTHA PIPERITA, ROSMARINUS OFFICINALIS, VALERIANA OFFICINALIS, HELONIA DIOICA, AGNUS CASTUS, AMBRA GRISEA, CIMICIFUGA RACEMOSA, CONVALLARIA MAJALIS, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, DAMIANA, HYDRASTIS CANADENSIS, CAULOPHYLLUM THALICTROIDES, LILIUM TIGRINUM, SENECIO AUREUS, STAPHYSAGRIA, NAJA TRIPUDIANS	Marco Pharma International LLC.	5a8ae10c-87a4-4751-9885-d84b0cad574a	2026-01-26	Warnings	Exact identifier unii: G0R4UBI2ZZ
POKONZA potassium chloride	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	2d938cbf-27aa-4f9c-a582-5564d3b72465	2026-01-22	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Inflammation I	ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA	BioActive Nutritional, Inc.	3cb12181-ae7e-45c7-a1b1-e1952f36f8c3	2026-01-21	Warnings	Exact identifier unii: WQZ3G9PF0H
INSULIN DILUTING MEDIUM FOR Kirsty	WATER	Biocon Biologics Inc.	3db1d482-7e1f-aec6-79ef-3f305b4d8277	2026-01-20	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Viscum Belladonna	VISCUM BELLADONNA	Uriel Pharmacy Inc.	a4865726-445e-4cb7-b7c8-5b74b8dd4816	2026-01-16	Warnings	Exact identifier unii: WQZ3G9PF0H
Pulmo Echinacea	PULMO ECHINACEA	Uriel Pharmacy Inc.	14c19a33-ffcc-4b35-a0cc-9f8d44cbaf66	2026-01-16	Warnings	Exact identifier unii: WQZ3G9PF0H
Apis Belladonna	APIS BELLADONNA	Uriel Pharmacy Inc.	8db74171-1580-4459-a3d2-5862ef6aa827	2026-01-16	Warnings	Exact identifier unii: WQZ3G9PF0H
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6	2026-01-15	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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