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 28 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Inflammation	ANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEA	Newton Laboratories, Inc.	9c1da6dd-5c6c-72c1-e053-2995a90a2f5a	2025-08-27	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	8757d093-747b-4e97-af6d-4064b16178b2	2025-08-27	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Allergy and Sinus Relief	PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE	Schwabe North American, Inc.	c90cc6f5-14ec-41a3-a20a-4e8018bb02fb	2025-08-25	Warnings	Exact identifier unii: 660YQ98I10
Cold Flu Relief Berry Chewable	PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS	Schwabe North America, Inc.	fd62e45b-2f06-4146-af93-0eca805d0638	2025-08-25	Warnings	Exact identifier unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	149770d0-3a2c-4e75-80a3-ec842907920d	2025-08-25	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Cold Flu Relief Orange	COLD FLU RELIEF ORANGE	Schwabe North America, Inc.	2983e4bd-065a-4f9f-904f-440336106096	2025-08-25	Warnings	Exact identifier unii: U0NQ8555JD
Incontinence	ALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	994cbc8e-a221-1548-e053-2995a90a1f7f	2025-08-20	Warnings	Exact identifier unii: C9TD27U172 unii: W2469WNO6U unii: WQZ3G9PF0H
Indigestion-Gas	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9c1c1525-9752-275d-e053-2a95a90acf43	2025-08-20	Warnings	Exact identifier unii: G0R4UBI2ZZ
Indigestion-Gas	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9c1cd511-64d4-3607-e053-2995a90a6029	2025-08-20	Warnings	Exact identifier unii: G0R4UBI2ZZ
Snorestop	NUX VOMICA, BELLADONNA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, TEUCRIUM MARUM, HISTAMINUM HYDROCHLORICUM, LAUROCERASUS, CINCHONA, STRAMONIUM	Green Pharmaceuticals Inc	37f4ea81-691f-597b-e063-6294a90a84bd	2025-08-19	Warnings	Exact identifier unii: WQZ3G9PF0H
Natures Way Cold Flu Relief Fastactives Berry Flavored	PELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS WHOLE, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM TOP, SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC	Universal Synergetics, Inc	444081b1-c78f-4474-a084-e7bd2cc2eb3f	2025-08-14	Warnings	Exact identifier unii: U0NQ8555JD
Schuessler Tissue Salts Comb D Skin Disorders	KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA	Martin & Pleasance Pty Ltd	617303f8-4463-4a1e-a502-44abc181d91f	2025-08-13	Warnings	Exact identifier unii: 660YQ98I10
Schuessler Tissue Salts Comb D Skin Disorders	KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA	Martin & Pleasance Pty Ltd	03153d92-dc68-4b84-a8c9-634b1ffd7da1	2025-08-13	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Henry Schein, Inc.	bf8e8ac7-e6a8-4571-a0ea-7bcab89290f6	2025-08-12	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	3bdfced1-6e62-9e92-e063-6294a90a28aa	2025-08-08	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3be29fcc-765e-8653-e063-6394a90a59d5	2025-08-08	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	94ae03cc-b620-0dbb-e053-2a95a90a922c	2025-08-07	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	0cc57ece-f15a-4160-a5ea-8d6fa9f9e754	2025-08-07	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	47a87fb6-5e61-41c9-b759-10f7c74a67ce	2025-08-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	7956883f-0d31-4081-bbea-d9ea320a193b	2025-08-04	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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