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 33 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bestmade Natural Products BIO17	CALC FLUOR, KALI PHOS, KALI MUR	Bestmade Natural Products	30006a9d-ece8-9c31-e063-6294a90a969a	2025-03-23	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products Kali Mur	KALI MUR	Bestmade Natural Products	e9e6cba7-0703-422f-e053-2995a90abdee	2025-03-21	Warnings	Exact identifier unii: 660YQ98I10
StressCalm	ACONITUM NAPELLUS WHOLE, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, CHELIDONIUM MAJUS WHOLE, ABRUS PRECATORIUS SEED, VIBURNUM OPULUS BARK	Boiron	af489aa8-9737-33e1-e053-2995a90ad280	2025-03-21		Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
SINUSCALM	ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA	BOIRON	87fe007d-3911-c95a-e053-2995a90ad836	2025-03-20		Exact identifier unii: WQZ3G9PF0H
Renotox	TRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,	BioActive Nutritional, Inc.	f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e9	2025-03-20	Warnings	Exact identifier unii: 660YQ98I10
Renotox	TRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,	BioActive Nutritional, Inc.	2b691b17-296b-49d2-924e-c62522d4b9a7	2025-03-20	Warnings	Exact identifier unii: 660YQ98I10
Anxiety HP	ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUM	Energique, Inc.	191393fa-5f36-43c0-a183-09258eef9bda	2025-03-20	Warnings	Exact identifier unii: U0NQ8555JD
Natural Eyes Pink Eye Relief Fast Dissolving Tables	ACONITUM NAPELLUS, APIS MELLIFICA, EUPHRASIA OFFICINALIS, NATRUM ARSENICICUM, SULPHUR	TRP Company	30aca951-f896-42fd-e063-6294a90aba7e	2025-03-19	Warnings	Exact identifier unii: U0NQ8555JD
Natural Eyes Pink Eye Relief Fast Dissolving Tables	ACONITUM NAPELLUS, APIS MELLIFICA, EUPHRASIA OFFICINALIS, NATRUM ARSENICICUM, SULPHUR	TRP Company	30b558b5-db9e-06c0-e063-6294a90a0344	2025-03-19	Warnings	Exact identifier unii: U0NQ8555JD
Baby Nighttime Oral Pain Relief	ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE	Hyland' Inc.	58ef86b7-5b38-1591-e053-2991aa0aa53e	2025-03-17	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bestmade Natural Products Restful Legs Support	CALCAREA PHOSPHORICA, ACONITE NAP, ANACARDIUM ORI, ARGENTUM NIT, ARSENIC ALB, AURUM MUR, CHAMOMILLA, DUBOISIA, GELSEMIUM, IGNATIA, KALI BROM, LACHESIS MUTUS, LYCOPODIUM, MAG MUR, MOSCHUS, NAT CARB, NAT SULPH, PHOSPHORIC ACID, RAUWOLFIA SERP	Bestmade Natural Products	304b48ac-c4b8-a5c0-e063-6394a90a07b6	2025-03-14	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Bestmade Natural Products BIO28 Lactose Free	CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA	Bestmade Natural Products	303b4d92-9f75-38a5-e063-6294a90ae93d	2025-03-13	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO4 Lactose Free	CALC FLUOR, KALI MUR, NAT MUR, SILICEA	Bestmade Natural Products	30220aca-e052-95f3-e063-6294a90a9cea	2025-03-12	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO5 Lactose Free	FERR PHOS, KALI MUR, NAT MUR, KALI SULPH	Bestmade Natural Products	30225814-b9d7-f16a-e063-6294a90a0194	2025-03-12	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO6 Lactose Free	FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPH	Bestmade Natural Products	302292bd-9c38-2638-e063-6294a90a965d	2025-03-12	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO9 Lactose Free	FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS	Bestmade Natural Products	302320d8-5ef8-a82a-e063-6294a90a7ea6	2025-03-12	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO10 Lactose Free	CALC PHOS, FERR PHOS, KALI MUR	Bestmade Natural Products	3025d49f-24d7-5013-e063-6294a90a1cd4	2025-03-12	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO11 Lactose Free	FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPH	Bestmade Natural Products	3025f91f-bc0a-691c-e063-6294a90ad136	2025-03-12	Warnings	Exact identifier unii: 660YQ98I10
Lymphastat V	ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, RHUS TOX, PYROGENIUM, INFLUENZINUM (2023-2024)	Energique, Inc.	c0ef1647-22f9-4cfa-a7e6-90c47c93dbde	2025-03-11	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Bestmade Natural Products BIO28	CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA	Bestmade Natural Products	300ead4c-6937-d597-e063-6394a90ad6bb	2025-03-11	Warnings	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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