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 42 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
D-71	ACONITUM NAPELLUS, ARSENIC TRIOXIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	DNA Labs, Inc.	478668a3-bf20-4205-a81a-2f9e4565f876	2025-01-13	Warnings	Exact identifier unii: U0NQ8555JD
D-75	CAULOPHYLLUM THALICTROIDES ROOT, MATRICARIA CHAMOMILLA, BLACK COHOSH, CUPRIC ACETATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND VIBURNUM OPULUS BARK	DNA Labs, Inc.	28558d59-8e55-4a72-8d42-de3f54d4ebbb	2025-01-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
D-112	LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	DNA Labs, Inc.	8d517ef2-3a1e-4393-9452-a4cd0f0a3bca	2025-01-13	Warnings	Exact identifier unii: W2469WNO6U unii: U0NQ8555JD
D-117	ATROPA BELLADONNA AND SILICON DIOXIDE	DNA Labs, Inc.	8bcce284-f8f3-4d62-a13e-b93c2c655a70	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-119	PLANTAGO MAJOR, DELPHINIUM STAPHISAGRIA SEED, MATRICARIA CHAMOMILLA, SEPIA OFFICINALIS JUICE, ARNICA MONTANA, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, SPIGELIA ANTHELMIA, IRON, BARIUM CARBONATE, VERATRUM ALBUM ROOT, CALCIUM FLUORIDE, ANTIPYRINE, AND BISMUTH SUBNITRATE	DNA Labs, Inc.	c9463aa1-ac37-42f9-bc2b-785e3d2befad	2025-01-13	Warnings	Exact identifier unii: W2469WNO6U unii: G0R4UBI2ZZ
D-91	APIS MELLIFERA AND ATROPA BELLADONNA	DNA Labs, Inc.	dac07ef4-d76c-47c1-a29a-e76a1fa78ea8	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-109	ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLE	DNA Labs, Inc.	7758341d-e0be-487a-ba47-8847551231e1	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-137	APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIG	DNA Labs, Inc.	240d03c0-957b-48e4-9bab-43f9e6b8fb42	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
D-133	CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATE	DNA Labs, Inc.	a250b7e9-7fd2-4cb0-82f3-baa089d17441	2025-01-13	Warnings	Exact identifier unii: 660YQ98I10
D-152	ARSENIC TRIOXIDE, STRYCHNOS NUX-VOMICA SEED, ACONITUM NAPELLUS, GOLD, CAUSTICUM, HYOSCYAMUS NIGER LEAF, LACHESIS MUTA WHOLE, DAPHNE MEZEREUM WHOLE, ANEMONE PULSATILLA, SULFUR, AND VERATRUM VIRIDE WHOLE	DNA Labs, Inc.	e8968153-24c0-474d-8f4d-493481f44206	2025-01-13	Warnings	Exact identifier unii: U0NQ8555JD
D-139	ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARBO VEGETABILIS, FERRUM PHOSPHORICUM, LYCOPODIUM, NATRUM PHOSPHORICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, HYDRASTIS	DNA Labs, Inc.	e830774e-35c8-7309-e053-2995a90ae043	2025-01-13	Warnings	Exact identifier unii: WQZ3G9PF0H
Sambucus Cold Flu Relief Elderberry	PELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC	Schwabe North America, Inc.	5de8a3db-6103-4b69-8e47-c78bc7c6bfcd	2025-01-10	Warnings	Exact identifier unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	81a53ecd-2612-4efe-9491-415fff3f86e5	2025-01-09	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a01c5f5-e9d9-5ac1-e053-2995a90a137e	2025-01-09		Exact identifier unii: U0NQ8555JD
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a01ab86-eed0-5f1d-e053-2a95a90aff56	2025-01-09		Exact identifier unii: U0NQ8555JD
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a020fba-31b0-3b89-e053-2a95a90a9be6	2025-01-09		Exact identifier unii: U0NQ8555JD
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a022465-f2b8-b503-e053-2a95a90aec7d	2025-01-09		Exact identifier unii: U0NQ8555JD
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a02d6b6-5385-5ec4-e053-2a95a90a149a	2025-01-09		Exact identifier unii: U0NQ8555JD
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a01a463-54dc-6457-e053-2a95a90a35e6	2025-01-09		Exact identifier unii: U0NQ8555JD
Aconitum napellus	ACONITUM NAPELLUS	Hahnemann Laboratories, Inc.	9a029ec5-9459-981e-e053-2995a90a9359	2025-01-09		Exact identifier unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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