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 51 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Energique, Inc.	d22d399e-d2e3-4833-b59a-d841022cc02f	2024-09-30	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Pest and Dustmite Formula	AMYL NITROSUM, EUPHRASIA OFFICINALIS, KALI MURIATICUM, WYETHIA HELENOIDES, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, GLANDULA SUPRARENALIS SUIS, MUCOSA NASALIS SUIS, ALLIUM CEPA, ARSENICUM ALBUM, BLATTA AMERICANA, IRIDIUM METALLICUM, SABADILLA, SELENIUM METALLICUM, LAC FELINUM, HYALURONIDASE, INTERFERON (SUIS), SEROTONIN (HYDROCHLORIDE), HOUSE DUST MITE	Deseret Biologicals, Inc.	b1d685d3-a51e-4070-957d-efce7cf91655	2024-09-27	Warnings	Exact identifier unii: 660YQ98I10
Flu HP	ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS	Energique, Inc.	293a47b3-10b4-4f01-8549-9071014e2803	2024-09-24	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Tobacco	CHAMOMILLA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ALLIUM SATIVUM, ARGENTUM NITRICUM, AVENA SATIVA, CALADIUM SEGUINUM, KALI BICHROMICUM, LOBELIA INFLATA, LYCOPODIUM CLAVATUM, SEROTONIN (HYDROCHLORIDE), TABACUM, ADRENALINUM, AMMONIACUM GUMMI, BALSAMUM PERUVIANUM, CACTUS CACTI, SELENIUM METALLICUM	Deseret Biologicals, Inc.	68d6780a-e247-48d9-9a54-4b7c6a3e6816	2024-09-23	Warnings	Exact identifier unii: G0R4UBI2ZZ
Lymphapar	ECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEA	Energique, Inc.	c746c111-7ebc-46c1-b11b-04271887df9c	2024-09-23	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Bryant Ranch Prepack	b5505a39-57f1-4ed5-b845-4f1d8aa10950	2024-09-23	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	8bae6f0f-58ca-490f-a725-8ec4bc6ba514	2024-09-18	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Respiforce F-HP	ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS	BioActive Nutritional, Inc.	a507329a-acd6-4a1e-bf8a-0223339129e7	2024-09-12	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Mood Swings	CAMPHORA, CIMICIFUGA RACEMOSA, CROCUS SATIVUS, KALI BROMATUM, LITHIUM CARBONICUM, ADRENALINUM, DOPAMINE HYDROCHLORIDE, HYPOTHALAMUS SUIS, SEROTONIN (HYDROCHLORIDE), THYROIDINUM (SUIS), ACONITUM NAPELLUS, HYOSCYAMUS NIGER, IGNATIA AMARA, OENANTHE CROCATA, PULSATILLA (PRATENSIS), STRAMONIUM, TARENTULA HISPANA, ZINCUM METALLICUM, LACHESIS MUTUS, PLATINUM METALLICUM	Deseret Biologicals, Inc.	f3b9a2ac-eeae-4fab-aa10-8b01f2966482	2024-09-11	Warnings	Exact identifier unii: U0NQ8555JD
AnXious	CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENS	Deseret Biologicals, Inc.	49bec2b3-cf6a-447d-8d43-9e8d2edd0102	2024-09-11	Warnings	Exact identifier unii: U0NQ8555JD
Dairy Allergen Mix	ADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,	Deseret Biologicals, Inc.	e03d8463-287a-4509-a9f4-0ad38a98377c	2024-09-11	Warnings	Exact identifier unii: G0R4UBI2ZZ
Rage	APIS MELLIFICA, CANTHARIS, CHAMOMILLA, ADRENALINUM, CEREBRUM SUIS, HYPOPHYSIS SUIS, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ATROPINUM, CAUSTICUM, CICUTA VIROSA, CUPRUM METALLICUM, HYOSCYAMUS NIGER, LAC CANINUM, MOSCHUS, STRAMONIUM, TARENTULA HISPANA, VERATRUM ALBUM, HOMARUS, CAMPHORA	Deseret Biologicals, Inc.	cb2e014a-dc0f-4bd2-b302-f1bc6d900e8e	2024-09-11	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
LYMPHASTAT V	ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, RHUS TOX, PYROGENIUM	Energique, Inc.	2adc6a95-c8a5-4579-92d6-594b6917c5a9	2024-09-11	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
VERBASCUM THAPSUS	VERBASCUM THAPSUS WHOLE	Boiron	21b527fb-64d0-efa6-e063-6394a90a714e	2024-09-09		Exact identifier unii: C9TD27U172
Dairy Allergen Mix	ADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE,	Deseret Biologicals, Inc.	e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf	2024-09-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Digestive Enzyme Liquescence	CHAMOMILLA, CINNAMOMUM, CORIANDRUM SATIVUM, ILLICIUM ANISATUM, RHEUM (PALMATUM), SYZYGIUM JAMBOLANUM, ZINGIBER OFFICINALE, ANGELICA ARCHANGELICA, CARDAMOMUM (ELETTARIA CARDAMOMUM), MYRRHA, ALOE, CROCUS SATIVUS, GALLBLADDER (BOVINE), PANCREAS SUIS, STOMACH (SUIS), PAPAIN, CAMPHORA, VALERIANA OFFICINALIS, BROMELAIN	Nutritional Specialties, Inc.	5c667764-254f-416b-9b23-95760f9fbbfb	2024-09-03	Warnings	Exact identifier unii: G0R4UBI2ZZ
Gum Therapy	ACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIA	Deseret Biologicals	ceb5203b-b4c8-4c7b-8e18-ccbff5034fc1	2024-08-29	Warnings	Exact identifier unii: U0NQ8555JD
Gum Therapy	CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS	Deseret Biologicals	5c741edc-f3ce-4e43-bb3e-fb7316621406	2024-08-28	Warnings	Exact identifier unii: U0NQ8555JD
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	863e6980-4a66-48a5-a14f-828a00480c93	2024-08-23	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Upper Respiratory Support	ALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOX	Deseret Biologicals, Inc.	882a284f-aa25-40cf-8aff-fe4c38ff3f0a	2024-08-23	Warnings	Exact identifier unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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