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 63 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BHI Back	AMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAF	MediNatura Inc	aa622a5b-16de-4098-9c3f-d7569f7d2c2f	2023-05-23	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bacteriostatic Water	WATER	Medical Purchasing Solutions, LLC	69485218-9343-952d-e053-2a91aa0ad4e8	2023-05-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Backache Relief	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANA	Hyland's Inc.	a51452b3-0aba-6928-e053-2995a90a1619	2023-05-10	Warnings	Exact identifier unii: U0NQ8555JD
Sterile Water	STERILE WATER	Hikma Pharmaceuticals USA Inc.	b20a28b0-7dfa-42eb-9177-ec256d5a5ef7	2023-05-08	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Baby Nighttime Mucus Plus Cold Relief	CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA	Hyland's Inc.	736b2487-e81d-d172-e053-2a91aa0ab0cf	2023-04-17	Warnings	Exact identifier unii: G0R4UBI2ZZ
BHI Flu Plus	ACONITUM NAPELLUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, AND ZINC	MediNatura Inc	8d73082d-a1bc-4e76-9714-49f718b5850b	2023-04-13	Warnings	Exact identifier unii: U0NQ8555JD
Chamomilla	CHAMOMILLA	Newton Laboratories, Inc.	f912a32e-9bc9-c195-e053-6294a90a3e20	2023-04-11	Warnings	Exact identifier unii: G0R4UBI2ZZ
Sterile Water	WATER	Civica, Inc.	3f49eedf-5bf5-4a95-b704-c956d860ca04	2023-04-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Treprostinil	TREPROSTINIL	Sandoz Inc	473297ca-a872-4052-a053-87dc8f0d3c13	2023-04-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
StressCalm	ACONITUM NAPELLUS, ATROPA BELLADONNA, CHELIDONIUM MAJUS, CALENDULA OFFICINALIS FLOWERING TOP, VIBURNUM OPULUS BARK, ABRUS PRECATORIUS SEED	Boiron	ddcbbaae-ca20-9e18-e053-2a95a90a267f	2023-04-05		Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Belladonna and Opium	ATROPA BELLADONNA AND OPIUM	Padagis US LLC	8301e76b-134a-43d2-a7dc-c600ccf2695c	2023-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WQZ3G9PF0H
Belladonna	ATROPA BELLADONNA	Boiron	84767820-0e21-3f25-e053-2a91aa0a6a18	2023-03-28		Exact identifier unii: WQZ3G9PF0H
Belladonna	ATROPA BELLADONNA	Boiron	8476ccac-b35e-8608-e053-2991aa0a6ac5	2023-03-27		Exact identifier unii: WQZ3G9PF0H
T-Relief	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	2bd442ca-0bbe-0bc3-e054-00144ff8d46c	2023-03-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Traumed	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	8cd4745f-2f4b-4cdf-868b-c5a089a16599	2023-03-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Traumex	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	335c8bec-f0c3-4b95-a6a6-5fda262be0e6	2023-03-20	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Myco Immuno Nosode	DU HUO (ANGELICA PUBESCENS), ANGELICA ARCHANGELICA, KALI MURIATICUM, RADIX SILERIS (SAPOSHNIKOVIA DIVARICATA), YUCCA FILAMENTOSA, ACHYRANTHES BIDENTATA, ANGELICA SINENSIS, LIGUSTICUM PORTERI, PANAX GINSENG, RHUS TOX, HYDRASTIS CANADENSIS, UNCARIA TOMENTOSA, CARTILAGO SUIS, HORDEUM VULGARE, OXALICUM ACIDUM, ARNICA MONTANA, LATRODECTUS MACTANS, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, BORRELIA BURGDORFERI, BABESIA MICROTI	Nutritional Specialties, Inc.	34dc93af-0c39-4e06-a8d6-9e1ccc77aa23	2023-03-17	Warnings	Exact identifier unii: 660YQ98I10
Traumeel	ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOT	Biologische Heilmittel Heel	9ff5c743-0e8f-4416-9964-c92b3abb54dd	2023-03-06	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Belladonna	ATROPA BELLADONNA	Boiron	85006162-c1ef-4978-e053-2a91aa0adbc4	2023-03-03		Exact identifier unii: WQZ3G9PF0H
Insulin Diluting Medium for NovoLog	WATER INJECTION	Novo Nordisk	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	2023-02-28	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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