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 61 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ringers	SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	b53c598c-dc7d-4a15-9319-8edf265e7b42	2023-08-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Belladonna	ATROPA BELLADONNA	Boiron	850013a3-19dd-b178-e053-2a91aa0a79dc	2023-08-29		Exact identifier unii: WQZ3G9PF0H
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier unii: 059QF0KO0R
Enuresis HP	ARGENTUM NITRICUM, BELLADONNA, CAUSTICUM, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, KREOSOTUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), THUJA OCCIDENTALIS, THYROIDINUM (SUIS)	Energique, Inc.	257e63e2-c0d6-4fc8-9a93-14d9eb50bc09	2023-08-24	Warnings	Exact identifier unii: WQZ3G9PF0H
V HP	ARSENICUM ALBUM, BELLADONNA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX	Energique, Inc.	61e1a347-fd21-4065-940d-1cc42006d9a7	2023-08-23	Warnings	Exact identifier unii: WQZ3G9PF0H
B HP	APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA	Energique, Inc.	8b1414d5-57d8-46d5-b4be-3011429bdd0d	2023-08-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Gallbladder Sarcode	CARDUUS MARIANUS, CHELIDONIUM MAJUS, BELLADONNA, LEPTANDRA VIRGINICA, GALLBLADDER (BOVINE), HEPAR (BOVINE), COLOCYNTHIS, CHOLESTERINUM	Nutritional Specialties, Inc.	4174f3cf-5eb4-48d2-945d-b1de10bf7731	2023-08-14	Warnings	Exact identifier unii: WQZ3G9PF0H
Breathtone	LOBELIA INFLATA, VERBASCUM THAPSUS, BALSAMUM PERUVIANUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHOROUS, SPONGIA TOSTA	Energique, Inc.	c388da29-824a-41a5-be85-47a60bccf3da	2023-08-14	Warnings	Exact identifier unii: C9TD27U172
Liver Gallbladder HP	BELLADONNA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), VERATRUM ALBUM	Energique, Inc.	2746b098-50ce-472f-a4c1-87ca659852b9	2023-08-07	Warnings	Exact identifier unii: WQZ3G9PF0H
Cellergy	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.	Ratis, LLC	2aebc11e-eeb7-436b-b90c-3a2f59fb7492	2023-08-07	Warnings	Exact identifier unii: 660YQ98I10
Occulopress	COLEUS FORSKOHLII, EUPHRASIA OFFICINALIS, VACCINIUM MYRTILLUS, SPIGELIA ANTHELMIA, ACONITUM NAPELLUS, BELLADONNA, HYDRASTIS CANADENSIS, EYE (SUIS), BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, PHOSPHORUS	Nutritional Specialties, Inc.	9dce6ad6-fe21-42ca-8888-6242ce29a744	2023-08-03	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
BHI Calming	MATRICARIA RECUTITA, ARABICA COFFEE BEAN, HOPS, STRYCHNOS IGNATII SEED, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, SULFUR, VALERIAN, AND VERATRUM ALBUM ROOT	MediNatura Inc	681b7b04-9dd9-493a-88dc-b3178069a903	2023-08-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f3bcf-0e45-d390-e063-6394a90a588e	2023-07-28	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f0210-195d-11d7-e063-6294a90aa750	2023-07-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Anti Stress Formula	APIS MELLIFICA, CITRUS VULGARIS, CLEMATIS VITALBA, FLOS, GLANDULA SUPRARENALIS (BOVINE), HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHORICUM, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS, SCUTELLARIA LATERIFLORA, VIBURNUM OPULUS, CORTISONE ACETICUM, ACONITUM NAPELLUS, ADRENALINUM, DOPAMINE (HYDROCHLORIDE)	Nutritional Specialties, Inc.	e476127e-105e-4e5c-8d94-147dd97c9288	2023-07-25	Warnings	Exact identifier unii: U0NQ8555JD
Attention Formula	CLEMATIS VITALBA, FLOS, CONVALLARIA MAJALIS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS, CEREBELLUM (SUIS), BELLADONNA, PHOSPHORUS, SEPIA, KIDNEY (BOVINE), LYCOPODIUM CLAVATUM	Nutritional Specialties, Inc.	96e0dc92-c4b4-4e8a-9bc8-d8a697f9ad4c	2023-07-24	Warnings	Exact identifier unii: WQZ3G9PF0H
Belladonna	ATROPA BELLADONNA	Boiron	85002c9f-662e-1c48-e053-2a91aa0ae920	2023-07-20		Exact identifier unii: WQZ3G9PF0H
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86099779-8dbd-a9eb-e053-2991aa0ab7a7	2023-07-20		Exact identifier unii: 660YQ98I10
Potassium chloride	POTASSIUM CHLORIDE	ANI Pharmaceuticals, Inc.	0128a879-7185-4b70-b0bb-d108ff1c9542	2023-07-20	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Melatonin Pro	CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)	Energique, Inc.	1f374642-83f7-4e64-b330-0f6ef21000a9	2023-07-19	Warnings	Exact identifier unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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