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 56 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Snore Stop Extinguisher Throat	ATROPA BELLADONNA, EPHEDRA DISTACHYA FLOWERING TWIG, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, TEUCRIUM MARUM	Green Pharmaceuticals Inc	158dc43d-1105-4757-9f3a-dbad961f8bd8	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H
A03 ULTRA ANTITOX	ALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSI	Apex Energetics Inc.	b945cb81-aee4-38e8-e053-2a95a90aa8df	2024-01-08	Warnings	Exact identifier unii: G0R4UBI2ZZ
B09 ACUTE VIROTOX	ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CHERRY PLUM, CLEMATIS VITALBA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, EUROPEAN OLIVE, FERRUM PHOSPHORICUM, GENTIANA LUTEA, IMPATIENS GLANDULIFERA, INFLUENZA A VIRUS, LACHESIS MUTUS, LUFFA OPERCULATA, ORNITHOGALUM UMBELLATUM, PHOSPHORUS, ROCKROSE, SARCOLACTICUM ACIDUM, VERATRUM ALBUM, YELLOW JASMINE	Apex Energetics Inc.	bed7fba6-605c-4696-e053-2a95a90a457f	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
B14 BRONCHOTOX	BELLADONNA, BLATTA ORIENTALIS, COCCUS CACTI, CORALLIUM RUBRUM, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, HEDERA HELIX, HYDRASTIS CANADENSIS, IPECACUANHA, KALI NITRICUM, LAC VACCINUM, LOBELIA INFLATA, PASSIFLORA INCARNATA, PERTUSSINUM, SAMBUCUS NIGRA, THYMUS SERPYLLUM, VALERIANA OFFICINALIS	Apex Energetics Inc.	beeaca49-a683-7e57-e053-2995a90ac04f	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H
A05 HEAVY ANTITOX	ALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUM	Apex Energetics Inc.	b9bdc39e-8ebf-615c-e053-2a95a90afe1b	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H
B11 INJUROTOX	ARISTOLOCHIA MILHOMENS, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, CHERRY PLUM FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER, LACHESIS MUTUS, MILLEFOLIUM, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE FLOWER, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, SYMPHYTUM OFFICINALE, VERATRUM ALBUM	Apex Energetics Inc.	baecce61-0514-abe5-e053-2995a90a12a8	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
B06 Stress Resistance	AVENA SATIVA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COFFEA CRUDA, ENGLISH OAK, ESCHSCHOLTZIA CALIFORNICA, EUROPEAN HORNBEAM, FICUS CARICA, HUMULUS LUPULUS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, KALI PHOSPHORICUM, KALI SILICATUM, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PYRENEES STAR OF BETHLEHEM, ROCKROSE, SUS SCROFA PARASYMPATHETIC NERVE, PINEAL GLAND, SYMPATHETIC NERVE, VALERIANA OFFICINALIS, VERBENA OFFICINALIS, ZINCUM VALERIANICUM	Apex Energetics Inc.	baeb5252-49b5-149c-e053-2995a90a2000	2024-01-08	Warnings	Exact identifier unii: G0R4UBI2ZZ
B01 ACUTE RESCUE	ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUM	Apex Energetics Inc.	4ce96ca9-8964-4b60-9d99-bf01d3d1cb43	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
D06 BLDR-DRN	APIS MELLIFICA, ARGENTUM NITRICUM, BADIAGA, BELLADONNA, CANTHARIS, CAUSTICUM, CHIMAPHILA UMBELLATA, COLOCYNTHIS, CUBEBA OFFICINALIS, CUCURBITA CITRULLUS, CUCURBITA PEPO FLOWER, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, ERYNGIUM AQUATICUM, FERRUM PHOSPHORICUM, MITCHELLA REPENS, OLEUM SANTALI, PETROSELINUM SATIVUM, PIPER METHYSTICUM, POPULUS TREMULOIDES BARK, SARSAPARILLA, TEREBINTHINA, UVA URSI	Apex Energetics Inc.	bc423f19-f85e-0373-e053-2995a90a1e1c	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H
D09 SNS-DRN	AMBROSIA ARTEMISIAEFOLIA, ARALIA RACEMOSA, ARNICA MONTANA, CALENDULA OFFICINALIS, CHROMICUM ACIDUM, ECHINACEA PURPUREA, EUCALYPTOL, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC VACCINUM, MERCURIUS IODATUS FLAVUS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, ROSA DAMASCENA, SABADILLA, SANGUINARINUM NITRICUM, SYMPHYTUM OFFICINALE	Apex Energetics Inc.	bc7efab4-7791-9759-e053-2a95a90a3109	2024-01-08	Warnings	Exact identifier unii: 660YQ98I10
D01 DRAINAGE COMPLEX	ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE	Apex Energetics Inc.	ba7020bf-3fc5-4fbf-e053-2995a90a70d7	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H
D08 LNG-DRN	ACONITUM NAPELLUS, AMERICAN GINSENG, ARSENICUM IODATUM, BLATTA ORIENTALIS, CALCAREA SULPHURICA, CARPINUS BETULUS FLOWER, CUPRUM METALLICUM, GRINDELIA, HEPAR SULPHURIS CALCAREUM, IPECACUANHA, JUSTICIA ADHATODA, KALI IODATUM, LOBELIA INFLATA, NAPHTHALINUM, NARCISSUS PSEUDONARCISSUS, PINE TAR, POPULUS CANDICANS, TABACUM, THUJA OCCIDENTALIS, THYMUS SERPYLLUM	Apex Energetics Inc.	bc3f76ef-66dd-c8eb-e053-2995a90a59f1	2024-01-08	Warnings	Exact identifier unii: U0NQ8555JD
F02 ANGR-FLX	ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE	Apex Energetics Inc.	bc7c2bf3-8b0d-766f-e053-2a95a90ad34c	2024-01-08	Warnings	Exact identifier unii: 059QF0KO0R
F09 LTGO	ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS	Apex Energetics Inc.	bd1e652f-b3a4-c5bd-e053-2995a90ae03f	2024-01-08	Warnings	Exact identifier unii: 059QF0KO0R
F25 LF-CHNGS	AGRIMONY FLOWER	Apex Energetics Inc.	bf3c7a21-0e4e-6395-e053-2a95a90a7156	2024-01-08	Warnings	Exact identifier unii: W2469WNO6U
W04 NEUROCALM	AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM	Apex Energetics Inc.	bf50b27a-e6d0-5393-e053-2995a90a1dff	2024-01-08	Warnings	Exact identifier unii: G0R4UBI2ZZ
R01 LIVER	ADENOSINE TRIPHOSPHATE, MATRICARIA CHAMOMILLA, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS	Apex Energetics Inc.	bb26bf36-78ee-2a23-e053-2995a90ae406	2024-01-08	Warnings	Exact identifier unii: G0R4UBI2ZZ
N09 BACTEROTOX	ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALIS	Apex Energetics Inc.	ba99bb1e-c36f-8bf8-e053-2995a90ac308	2024-01-08	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier unii: 059QF0KO0R
Cough Syrup Formula	DROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUS	BioActive Nutritional, Inc.	ade129ac-3a50-47fe-87be-8efc3a64d2cd	2024-01-05	Warnings	Exact identifier unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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