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 32 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Airway Ease	INFLUENZINUM, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB., KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA.	Newton Laboratories, Inc.	96b282c0-002b-7363-e053-2a95a90acd97	2025-05-07	Warnings	Exact identifier unii: C9TD27U172
Virimmune	ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2024-2025), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUM	Deseret Biologicals, Inc.	ac036ad8-6f48-4c15-b021-dc9bbb7e642e	2025-05-06	Warnings	Exact identifier unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	a230185f-5493-487d-892a-5219869b4e47	2025-05-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
ThroatSpray	ECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM	Energique, Inc.	125ffbf4-681e-451c-a96d-0b6416619474	2025-04-29	Warnings	Exact identifier unii: WQZ3G9PF0H
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	ab147ac2-d7d5-46d1-a2de-d866219197c1	2025-04-28	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Childrens Cold Crush	ACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRA	Genexa Inc.	32ece9d6-b346-6304-e063-6394a90a182d	2025-04-16	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	da32d4e3-f049-e7c8-e053-2a95a90a5790	2025-04-15	Warnings	Exact identifier unii: WQZ3G9PF0H
Umcka Fastactv Berry	PELARGONUIM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS, BRYONIA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, ALPHA CF	ProSolutions Inc	eedab4b9-509b-3fe5-e053-2995a90a2027	2025-04-10	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products BM13 Pellets	BELLADONNA, CUPRUM ACETICUM, DROSERA , GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTA	Bestmade Natural Products	3241a46c-d3ce-08be-e063-6294a90af2ee	2025-04-08	Warnings	Exact identifier unii: WQZ3G9PF0H
Chamomilla 7X	MATRICARIA RECUTITA	True Botanica, LLC	227daf6d-95e6-b320-e063-6394a90a10c0	2025-04-07	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bestmade Natural Products Kali Mur 8x	KALI MURIATICUM	Bestmade Natural Product	31e0092d-807b-588d-e063-6394a90aa532	2025-04-03	Warnings	Exact identifier unii: 660YQ98I10
Genexa Stress	ACONITUM NAPELLUS, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS	Genexa Inc.	b86a2e37-fbc0-7c31-e053-2a95a90ad5d0	2025-04-02	Warnings	Exact identifier unii: U0NQ8555JD
Sleepology	ALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALIS	Genexa Inc.	1e11f655-374c-59ac-e054-00144ff8d46c	2025-04-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
Eye Wash	WATER	CMC Group Inc.	6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561	2025-04-02	Warnings	Exact identifier unii: 059QF0KO0R
Respiforce A	ARNICA MONTANA, ASCLEPIAS TUBEROSA, ERIODICTYON CALIFORNICUM, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, PLANTAGO MAJOR, TRIFOLIUM PRATENSE, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CARBO VEGETABILIS, GRINDELIA, KALI CARBONICUM, NATRUM SULPHURICUM, PULSATILLA,	BioActive Nutritional	e9360698-bffb-4c91-b019-22e1e56704ee	2025-04-02	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H
Ovaplex	ANGELICA ARCHANGELICA, CAULOPHYLLUM THALICTROIDES, DIOSCOREA VILLOSA, HYPOPHYSIS SUIS, OOPHORINUM (SUIS) THYROIDINUM (SUIS), UTERUS SUIS, ZINCUM GLUCONICUM, APIS MELLIFICA, BELLADONNA, CIMICIFUGA RACEMOSA, MAGNESIA PHOSPHORICA, SEPIA	BioActive Nutritional, Inc.	cdbc8dc0-ac22-46af-a516-a3b5ca358197	2025-04-02	Warnings	Exact identifier unii: WQZ3G9PF0H
Coldcalm	ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION	Laboratoires Boiron	af4a4765-8255-44fb-821c-4345a2a45e2a	2025-04-01	Warnings	Exact identifier unii: WQZ3G9PF0H
Potassium Chloride	POTASSIUM CHLORIDE	Endo USA, Inc.	a64d7151-09a6-474c-83fc-36c7cf582d32	2025-03-26	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM60	CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6	Bestmade Natural Products	29912fb7-8712-18d9-e063-6394a90a82f7	2025-03-25	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BIO17 Lactose Free	CALC FLUOR, KALI PHOS, KALI MUR	Bestmade Natural Products	3036e6be-efc7-7b2b-e063-6294a90a3fdc	2025-03-23	Warnings	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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