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 41 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
D-5	SILVER NITRATE, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM SPORE, SEMECARPUS ANACARDIUM JUICE, SCROPHULARIA NODOSA, ATROPA BELLADONNA, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, AND CHELIDONIUM MAJUS	DNA Labs, Inc.	c286e9b3-51c6-4633-aef1-cda2505c1fa0	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
D-42	HORSE CHESTNUT, ATROPA BELLADONNA, CALCIUM FLUORIDE, MILK THISTLE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, DAPHNE MEZEREUM BARK, ANEMONE PRATENSIS, CLAVICEPS PURPUREA SCLEROTIUM, VIPERA BERUS VENOM, AND BOS TAURUS PLACENTA	DNA Labs, Inc.	400cbb19-5475-43ee-8630-608e673dc986	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-30	STRONTIUM SALICYLATE, METHENAMINE, COLCHICUM AUTUMNALE BULB, BLACK COHOSH, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, SOLANUM DULCAMARA WHOLE, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, AND TOXICODENDRON PUBESCENS LEAF	DNA Labs, Inc.	0e74e654-4bda-4969-89be-8ab89014bce2	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-9	CUPRIC ACETATE, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, DROSERA ROTUNDIFOLIA, ATROPA BELLADONNA, HYOSCYAMUS NIGER, ONION, CORALLIUM RUBRUM EXOSKELETON, AND LOBARIA PULMONARIA	DNA Labs, Inc.	15cb964d-086f-40a6-8056-5f149f04ab4c	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-32	NITRIC ACID, ATROPA BELLADONNA, PILOCARPUS JABORANDII WHOLE, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SAMBUCUS NIGRA FLOWERING TOP, SEPIA OFFICINALIS JUICE, SANGUINARIA CANADENSIS ROOT, VERATRUM ALBUM ROOT, AND SAGE	DNA Labs, Inc	81bb16d9-9c93-48d3-85ca-81c118a1c4a0	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-33	ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINC	DNA Labs, Inc.	26f9bf6d-6038-42e8-b8c1-6c94ac4929af	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-43	ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATE	DNA Labs, Inc.	937e2b7e-4001-402f-bd12-dcff4627e928	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-70	ACONITUM NAPELLUS, SIMABA CEDRON SEED, CITRULLUS COLOCYNTHIS FRUIT PULP, KALMIA LATIFOLIA LEAF, AND VERBASCUM THAPSUS	DNA Labs, Inc.	3f6a830d-3406-4d2b-8673-0e5df9caa3ec	2025-01-13	Warnings	Exact identifier unii: C9TD27U172 unii: U0NQ8555JD
D-78	HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJOR	DNA Labs, Inc.	d62673a9-8a67-4580-a8bf-25f85960a555	2025-01-13	Warnings	Exact identifier unii: W2469WNO6U
D-80	BAPTISIA TINCTORIA ROOT, LACHESIS MUTA VENOM, ECHINACEA ANGUSTIFOLIA, BRYONIA ALBA ROOT, ACONITUM NAPELLUS, SOLIDAGO VIRGAUREA FLOWERING TOP, AND AVENA SATIVA FLOWERING TOP	DNA Labs, Inc.	83e4ab65-514d-47ab-9d99-147168587ab2	2025-01-13	Warnings	Exact identifier unii: U0NQ8555JD
D-98	STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARK	DNA Labs, Inc.	9b39b277-9eb2-44c9-9c0c-a8680a50e18d	2025-01-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
D-54	DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICE	DNA Labs, Inc.	68a206a8-6f66-4957-843c-4c4c0636e78f	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-62	ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, FERROSOFERRIC PHOSPHATE, MERCURIUS SOLUBILIS, AND ANEMONE PRATENSIS	DNA Labs, Inc.	1e70833f-5fcb-4e04-af34-ebe35d70321e	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-55	COMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, AND TOXICODENDRON PUBESCENS LEAF	DNA Labs, Inc.	1a316983-a023-4174-9aef-9e268a5799c1	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-35	ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, AND BRYONIA ALBA ROOT	DNA Labs, Inc.	275cc8ec-30ed-4dd9-815c-d082ee5b3a99	2025-01-13	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
D-103	ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TIN	DNA Labs, Inc.	f4efd03d-3f80-4694-9a02-b71b7e3e3f0d	2025-01-13	Warnings	Exact identifier unii: W2469WNO6U
D-51	ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATE	DNA Labs, Inc.	9928dd54-bd3a-47cb-bde5-4bebab3db683	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-96	CATNIP, MATRICARIA CHAMOMILLA, GINGER, AND MENTHA PIPERITA	DNA Labs, Inc.	88a53b92-fd44-40b6-ae8f-5b318757f6d0	2025-01-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
D-99	ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATE	DNA Labs, Inc.	dd9c0226-35ea-445a-a570-1ec35551f68d	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-125	POTASSIUM CHLORIDE	DNA Labs, Inc.	71b92f48-edee-49a4-a87f-7b284e1b45a0	2025-01-13	Warnings	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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