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 66 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACTOFLAM	APIS MEL, ARSENICUM ALB, BAPTISIA, BELLADONNA, ECHINACEA, FERRUM PHOS, RHUS TOX	White Manufacturing Inc. DBA Micro-West	b965fbd3-050d-4073-ab32-f67f0c5335f4	2022-12-02	Warnings	Exact identifier unii: WQZ3G9PF0H
VIREX	ARSENICUM ALB, BAPTISIA, BELLADONNA, ECHINACEA, EUPATORIUM PERF, GELSEMIUM, LYCOPODIUM, , NUX VOM, PHOSPHORICUM AC, PHOSPHORUS, PYROGENIUM, RHUS TOX	White Manufacturing Inc. DBA Micro-West	77b9e94e-e159-4b77-bd8a-9f5937ac2906	2022-12-02	Warnings	Exact identifier unii: WQZ3G9PF0H
Whole System Eep	BELLADONNA, BERBER VULG, CAUSTICUM, CEANOTHUS, CHELIDONIUM MAJ, CINCHONA, COFFEA CRUDA, CONDURANGO, GRAPHITES, HYDRASTIS, IGNATIA, LILIUM, LYCOPODIUM, , MERC CORROS, NUX VOM, PANCREAS, SCROPHULARIA NODOSA, SENNA, SPONGIA, ZINC MET	White Manufacturing Inc. DBA Micro-West	ccdee0bb-18cc-4180-ac4b-d9dc5c79895e	2022-12-02	Warnings	Exact identifier unii: WQZ3G9PF0H
Miranda Castros Healing Gel for Bites and Stings	CALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.	OHM PHARMA INC.	8e06aaa4-c177-45cf-9d8d-e0099de25668	2022-12-02	Warnings	Exact identifier unii: W2469WNO6U
Hevert Detox Kidney	NITRIC ACID, APIS MELLIFERA, ATROPA BELLADONNA, LYTTA VESICATORIA, JUNIPER BERRY, AND SOLIDAGO VIRGAUREA FLOWERING TOP	Hevert Arzneimittel GmbH & Co KG	cfad4864-7b02-4389-82f1-49669b651b48	2022-12-01	Warnings	Exact identifier unii: WQZ3G9PF0H
Immune Support	ARSENICUM ALBUM, RUMEX, SQUILLA MARITIMA, BRYONIA ALBA, KALI CARBONICUM, GLUTATHIONE, VITAMIN C, VITAMIN C, ZINC PICOLINATE, VITAMIN B, VITAMIN E, BETA GLUCAN, CURCUMIN, GRAPEFRUIT SEED, OREGANO LEAF, GARLIC BULB, OLIVE LEAF, APPLE CIDER VINEGAR, ASTRAGALUS ROOT, MAITAKE MUSHROOM, CATS CLAW BARK	ProBLEN	e6f26cf4-dc3d-4d31-aa3e-145167b6ba2b	2022-11-30	Warnings	Exact identifier unii: MJ95C3OH47
Yonis Bliss	CHAMOMILLA, NATRUM MURIATICUM	Brookhaus Essentials LLC	ea4091d6-d295-41a0-aae5-68f3c260e110	2022-11-30	Warnings	Exact identifier unii: G0R4UBI2ZZ
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
GUNA-FLU	ACONITUM NAPELLUS - ASCLEPIAS CURASSAVICA - ATROPA BELLADONNA - CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - COPPER - ECHINACEA ANGUSTIFOLIA - HAEMOPHILUS INFLUENZAE TYPE B -	Guna spa	84e8e18c-8a74-41d5-b285-1ecb788bba3d	2022-11-14	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Multiple Electrolytes pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	84221110-b3f1-42f4-800c-ad1d3b330e9e	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Multiple Electrolytes pH 5.5	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Unda 24	CRATAEGUS FRUIT, PASSIFLORA INCARNATA, BOLDO LEAF, VALERIANA OFFICINALIS ROOT, CHAMOMILLA, ALUMINIUM METALLICUM	Seroyal USA	0fd99c06-1ea8-7171-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: G0R4UBI2ZZ
UNDA 32	ACONITUM NAPELLUS, ARGENTUM METALLICUM,BORAGO OFFICINALIS, CAMPHORA, GRINDELIA, STANNUM METALLICUM	Seroyal USA	3d1dabe8-2b1b-52dd-e054-00144ff88e88	2022-11-09	Warnings	Exact identifier unii: U0NQ8555JD
Unda 36	ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, ALUMINIUM METALLICUM, CHELIDONIUM MAJUS, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM	Seroyal USA	26e7d64b-1a94-6de4-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: U0NQ8555JD
Angiplex	ARUM TRIPHYLLUM, ACONITUM NAPELLUS, APIS MELLIFICA, BELLADONNA, PHYTOLACCA DECANDRA, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS	Seroyal USA	0d04b1a0-6c43-5f25-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
FEBRIPLEX	ACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, MERCURIUS SOLUBILIS, RHUS TOXICODENDRON	Seroyal USA	52e1f6ff-f4b9-693a-e054-00144ff8d46c	2022-11-07	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
LEG CRAMPS	CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP	Hyland's Inc.	77630c9b-880d-4de1-ae25-5a01050727f7	2022-11-02	Warnings	Exact identifier unii: U0NQ8555JD
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Zydus Pharmaceuticals (USA) Inc.	31e02249-7984-4b8f-9e37-2b79b708ac08	2022-10-18	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Zydus Lifesciences Limited	099c3a36-f460-4191-80e5-0c4153a5c713	2022-10-18	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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