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 77 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Relief Teething Oral Liquid	CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUID	Homeolab International (Canada) inc	df6edd7a-3ca6-4946-b083-1193f4b1d226	2019-07-16	Warnings	Exact identifier unii: G0R4UBI2ZZ
Potassium Chloride in Dextrose	POTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	45de5402-5e61-4bbd-8bbc-5e3392c9920e	2019-07-15	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	431ff2ef-567c-4b60-af43-f4da61febaad	2019-07-03	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE EXTENDED-RELEASE	Solco Healthcare LLC	f704b746-ab75-4484-8704-5baa94a07750	2019-04-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Arnica Montana Nartex	ARNICA MONTANA NARTEX	Nartex Laboratorios Homeopaticos SA DE CV	86567f91-7792-1094-e053-2991aa0a4a0b	2019-04-12	Warnings	Exact identifier unii: G0R4UBI2ZZ
Tinnitus Relief	CINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.	Homeocare Laboratories	30d67273-b9ec-4f3e-ace6-87a68325aaf1	2019-02-28	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride in Dextrose and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride in Sodium Chloride	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sciatica Relief	ARNICA MONTANA FLOWER, BRYONIA ALBA WHOLE, MATRICARIA RECUTITA, PSEUDOGNAPHALIUM LUTEOALBUM LEAF, KALMIA LATIFOLIA LEAF, TOXICODENDRON PUBESCENS LEAF, VISCUM ALBUM LEAF	Homeocare Laboratories	5fbffd54-0007-4b9b-922f-1c0e450abd55	2018-12-31	Warnings	Exact identifier unii: G0R4UBI2ZZ
Eczema Relief	ANTIMONY TRISULFIDE, APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, GRAPHITE, ARCTIUM LAPPA FRUIT, KEROSENE, SOLIDAGO CANADENSIS WHOLE, VIOLA TRICOLOR	Homeocare Laboratories	1bfea3be-5909-4aa3-9ec3-05b4db2dd69b	2018-12-31	Warnings	Exact identifier unii: WQZ3G9PF0H
Sore Throat Relief	ACONITUM NAPELLUS,APIS MELLIFERA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,MERCURIUS SOLUBILIS,PHYTOLACCA AMERICANA ROOT.	Homeocare Laboratories	f8a65318-eb0f-48b4-9578-c7a6cf799bc1	2018-12-26	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
GUNA-SINUS NOSE	ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -	Guna spa	36fef678-17c6-4d2a-a0f0-ddb298611f25	2018-12-22	Warnings	Exact identifier unii: W2469WNO6U
Throat	BAPTISIA, PHYTOLACCA, HYDRASTIS, APIS MEL, ARG NIT, BELLADONNA, HEPAR SULPH CALC, KALI BIC, LAC CAN, LACHESIS, MERC SOLUB	Natural Creations, Inc	df764380-46e2-46fc-9b5b-a2eca71bbfbf	2018-12-21	Warnings	Exact identifier unii: WQZ3G9PF0H
E.N.V.	BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALB	Zorex International	838498ba-cab9-4e1b-a567-e7f1862b7fbb	2018-12-21	Warnings	Exact identifier unii: WQZ3G9PF0H
GUNA-RHINO NOSE	APIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - MELILOTUS - ONION - PLANTAGO MAJOR - ROSA CANINA FRUIT - SILVER NITRATE -	Guna spa	5baeb698-1735-4586-9984-2a2cb0da871a	2018-12-21	Warnings	Exact identifier unii: W2469WNO6U
GUNA-DERMO	ALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -	Guna spa	8bf717eb-fe46-4066-b124-eb715ffc1542	2018-12-21	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H
GUNA-HEMORRHOIDS	ACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELTATUM ROOT - PORK LIVER - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -	Guna spa	0fd0dcef-79c6-4489-a533-996aa5331d9c	2018-12-21	Warnings	Exact identifier unii: WQZ3G9PF0H
GUNA-ORAL	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -	Guna spa	f1b8e5ab-8689-4bf2-a6d9-863d02f29579	2018-12-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
GUNA-PMS	ARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -	Guna spa	86f341b1-a8f7-4833-a1be-e51610b05bcd	2018-12-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
Fever CP	ACONITUM NAPELLUS, BRYONIA ALBA, CALCAREA CARBONICA, FERRUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA, PYROGENIUM, SULPHUR	Natural Creations, Inc	ae23ff31-b23b-469c-9960-6613df769226	2018-12-21	Warnings	Exact identifier unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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