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 10 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Amneal Pharmaceuticals of New York LLC	cd56e147-92d6-46ce-ae00-63fac08d49b5	2026-03-03	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Pain Relief	ARNICA MONTANA, BELLADONNA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, MAGNESIA PHOSPHORICA, SANGUINARIA CANADENSIS, SALIX ALBA	NaturalCare	6eba2caa-958f-47a1-823c-c73bbb1d7fa9	2026-03-02	Warnings	Exact identifier unii: WQZ3G9PF0H
Restless Legs	ARSENICUM ALBUM, CAUSTICUM, CHAMOMILLA, LYCOPODIUM CLAVATUM, PALLADIUM METALLICUM, PLATINUM METALLICUM, ZINCUM METALLICUM	NaturalCare	1e245ee1-b76f-49ed-9403-9d91d0492ab9	2026-03-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
First Aid mind and Body	ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, RHUS TOX, SULPHUR, SYMPHYTUM, TRIFOLIUM PRATENSE, AND VERATRUM ALBUM.	King Bio Inc.	20d4a0a3-7e69-4956-aaff-21703e2bb030	2026-03-02	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Peace and Quiet	CHAMOMILLA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, MAGNESIUM MURIATICA, PASSIFLORA INCARNATA	NaturalCare	412b02bf-1382-418d-bd75-b7bf344dcd4e	2026-03-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
Influenseg	GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, GALPHIMIA GLAUCA, CAUSTICUM, EUPATORIUM PERFOLIATUM, IPECACUANHA, ACONITUM NAPELLUS, KALI BICHROMICUM, AVENA SATIVA, INFLUENZINUM (2024-2025), LOBELIA PURPURESCENS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ECHINACEA (ANGUSTIFOLIA), CANCHALAGUA	Nucleic Products, LLC	6d673ec9-fdb3-48a0-9a4f-bb65e290f9a4	2026-02-27	Warnings	Exact identifier unii: U0NQ8555JD
Rhus Aconitum	RHUS ACONITUM	Uriel Pharmacy Inc.	a176c241-fc2d-4fea-82d9-81183971b4cf	2026-02-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Chrysosplenium Chamomilla	CHRYSOSPLENIUM CHAMOMILLA	Uriel Pharmacy Inc.	d2c9746c-784b-4d76-874b-4f8ea6814f99	2026-02-27	Warnings	Exact identifier unii: G0R4UBI2ZZ
911 Stress and Anxiousness	ACONITUM NAPELLUS, ALFALFA, APIS MELLIFICA, AVENA SATIVA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS VITALBA, FLOS, HISTAMINUM HYDROCHLORICUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHORICUM, LILIUM TIGRINUM, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, PULSATILLA, AND VALERIANA OFFICINALIS.	King Bio Inc.	135d20b1-c87a-489b-b105-352b6048546a	2026-02-27	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Outdoor Allergies	ACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLEN	NaturalCare	b0a76faa-a081-4cee-ae40-e5605458bec3	2026-02-23	Warnings	Exact identifier unii: U0NQ8555JD
BM BIO28 (General Tonic)	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	38d2cff0-3550-b119-e063-6394a90a31cb	2026-02-23	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	2d67fc67-c99f-4df2-a1e7-4d369cce12c2	2026-02-23	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Kids Cough and Mucus Nighttime Grape Flavor	RUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATE	Hyland's Consumer Health Inc.	d83e7877-f599-b364-e053-2995a90ab35f	2026-02-19	Warnings	Exact identifier unii: G0R4UBI2ZZ
Celeragesic	ACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), ECHINACEA PURPUREA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MILLEFOLIUM, NADIDUM, PANTOTHENIC ACID, RHUS TOX, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE	Deseret Biologicals, Inc.	18e573b8-dd8d-432a-90c3-84b8929a4039	2026-02-18	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
ColdCalm	ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLE	Boiron	4ae2f15e-45f3-e2e4-e063-6294a90a92bc	2026-02-15	Warnings	Exact identifier unii: WQZ3G9PF0H
ThroatCalm	ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLE	Boiron	4ae45fc7-c0f4-3770-e063-6394a90ac80e	2026-02-15	Warnings	Exact identifier unii: WQZ3G9PF0H
KREOSOTE	ACID NIT, BELLADONNA, BORAX, CHAMOMILLA, KREOSOTE, MERC SOL, STAPHYSAGRIA	BM Private Limited	3b3cb32b-e7e3-3455-e063-6394a90aaafb	2026-02-15	Warnings	Exact identifier unii: WQZ3G9PF0H
SinusCalm	ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA WHOLE	Boiron	4ae58d81-3952-b372-e063-6394a90a8499	2026-02-15	Warnings	Exact identifier unii: WQZ3G9PF0H
Fuligo	CIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEA	BM Private Limited	3b27225f-4587-d915-e063-6294a90a7225	2026-02-12	Warnings	Exact identifier unii: 660YQ98I10
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Major Pharmaceuticals	33ad1eb2-1f05-461c-b01d-82dee4231556	2026-02-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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