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 46 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NativeRemedies Anger-Soothe	CHAMOMILLA, LYCOPODIUM, NUX VOMICA	Silver Star Brands	f67f7955-c4e9-64d7-e053-2995a90ac756	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Headache Ease	AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA	Silver Star Brands	c689fb16-6200-ac94-e053-2995a90a703d	2025-01-01	Warnings	Exact identifier unii: WQZ3G9PF0H
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Belly Calm	ARG NIT, ASAFOETIDA, CARBO VEG, CHAMOMILLA, LYCOPODIUM, MAG PHOS, NAT PHOS, NUX MOSCH, ZINGIBER.	Silver Star Brands	e661bbd8-6a1d-1019-e053-2995a90ae888	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Tula Tantrum Tamer	CHAMOMILLA, CINA	Silver Star Brands	bc2bd616-272f-94d0-e053-2a95a90a598e	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Stress Away Anxiety Relief	ACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUM	Silver Star Brands	05e04129-e7c1-4e11-e063-6394a90a09ca	2025-01-01	Warnings	Exact identifier unii: U0NQ8555JD
Mucus-Clear Jr.	ALLIUM CEPA, FERRUM PHOS, KALI BIC, KALI CARB, KALI MUR	Silver Star Brands	83098e43-d89d-21ff-e053-2991aa0affde	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Good Night Sleep	ACONITUM NAP,AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAG, VALERIANA	Silver Star Brands	9d5e8a6b-b908-26ee-e053-2995a90ae8c5	2025-01-01	Warnings	Exact identifier unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	Proficient Rx LP	7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce	2025-01-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
TREE ANTIGEN	POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE	Natural Creations, Inc	8040ab36-90eb-4076-a478-9b82ccfa4ec9	2024-12-23	Warnings	Exact identifier unii: WQZ3G9PF0H
Trace Mineral Cord	ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,	Energique, Inc.	902dd68d-5ce1-481e-8938-6487dcc68dfc	2024-12-19	Warnings	Exact identifier unii: 660YQ98I10
THROATCALM	ECHINACEA ANGUSTIFOLIA WHOLE, PLANTAGO MAJOR WHOLE	Boiron	f5788da2-f60b-d0b8-e053-2995a90a11c7	2024-12-18	Warnings	Exact identifier unii: W2469WNO6U
Pest and Dustmite Formula	ALLIUM CEPA, AMYL NITROSUM, ARSENICUM ALBUM, BLATTA AMERICANA, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HISTAMINUM HYDROCHLORICUM, HOUSE DUST MITE, HYALURONIDASE, INTERFERON (SUIS), IRIDIUM METALLICUM, KALI MURIATICUM, LAC CANINUM, MUCOSA NASALIS SUIS, SABADILLA, SELENIUM METALLICUM, SEROTONIN (HYDROCHLORIDE), WYETHIA HELENOIDES	Deseret Biologicals, Inc.	5a56ccec-5580-47da-a612-79aa9dc12948	2024-12-13	Warnings	Exact identifier unii: 660YQ98I10
Epiforce P	BAPTISIA TINCTORIA, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM IODATUM, CALCAREA CARBONICA, CLEMATIS ERECTA, GRAPHITES, KALI MURIATICUM, KALI SULPHURICUM, MEZEREUM PETROLEUM, SEPIA	BioActive Nutritional, Inc.	d33282bf-2045-4b92-a377-013fa711c877	2024-12-12	Warnings	Exact identifier unii: 660YQ98I10
Mast Cell Pro	HYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,	Energique, Inc.	5cd31e1d-0312-48d1-9ecd-d01c6fe3b672	2024-12-11	Warnings	Exact identifier unii: U0NQ8555JD
Fendall Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	afda6fc3-7615-b0be-e053-2995a90a6208	2024-12-10	Warnings	Exact identifier unii: 059QF0KO0R
Quality Choice Ear Relief Drops	MATRICARIA CHAMOMILLA WHOLE, MERCURIUS SOLUBILIS, SULFUR	Chain Drug Marketing Association	8a4b75d2-cec0-4ac3-94e3-208a01feace7	2024-12-09	Warnings	Exact identifier unii: G0R4UBI2ZZ
Family Wellness Ear Relief Ear Drops	MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR	Family Dollar Services Inc	dba89b5c-fe1d-485d-a1af-d8cd1f15b615	2024-12-09	Warnings	Exact identifier unii: G0R4UBI2ZZ
Cough and Cold Relief	ARG MET, ARSENICUM ALB, BAPTISIA, BRYONIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, MERC COROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VAL	Silver Star Brands	9d4a851c-ebda-1918-e053-2995a90a4936	2024-12-03	Warnings	Exact identifier unii: 660YQ98I10
SciatiGon-M	ACONITUM NAPELLUS, BERBERIS VULGARIS, CHAMOMILLA, COLOCYNTHIS, MAGNESIA PHOSPHORICA, RHUS TOX	Silver Star Brands	8c175b30-07e2-157c-e053-2a95a90ac92f	2024-12-03	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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