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 54 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Immune Support	ECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, BAPTISIA TINCTORIA, SANGUINARIA CANADENSIS, ARISTOLOCHIA CLEMATITIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM, ASTRAGALUS MEMBRANACEUS, INFLUENZINUM (2022-2023), SPLEEN (SUIS), THYMUS,	Deseret Biologicals, Inc.	55e12503-4782-424a-8661-6107aa9838e2	2024-02-29	Warnings	Exact identifier unii: U0NQ8555JD
STRE PLUS	ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), CHAMOMILLA, KALI IODATUM, LAC CANINUM, AGARICUS MUSCARIUS, AILANTHUS GLANDULOSUS, APIS MELLIFICA, ARGENTUM NITRICUM, BAPTISIA TINCTORIA, BARYTA MURIATICA, CALCAREA CARBONICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, STRAMONIUM, ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA	Deseret Biologicals, Inc.	8e03667e-ae6a-4930-b117-3b14d5d26cb2	2024-02-22	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Lung Large Intestine Meridian Opener	ALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHUR	Deseret Biologicals, Inc	a5c17770-e1c0-48e7-8947-c0434c22cdab	2024-02-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
GI Drainage	CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS	Deseret Biologicals, Inc.	ff81e3ca-2f88-4daf-a734-083107269d3a	2024-02-21	Warnings	Exact identifier unii: 059QF0KO0R
Cough	IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN	Deseret Biologicals, Inc.	4a8deb4a-9f26-46a9-8d99-99df36407f22	2024-02-19	Warnings	Exact identifier unii: U0NQ8555JD
Flu Care	INFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEA	Newton Laboratories, Inc.	115c4835-46e3-3b6f-e063-6394a90a2c80	2024-02-14	Warnings	Exact identifier unii: U0NQ8555JD
Flu Care	INFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEA	Newton Laboratories, Inc.	115d1ae4-bcfa-7fdd-e063-6394a90a36ad	2024-02-14	Warnings	Exact identifier unii: U0NQ8555JD
Influenza	INFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEA	Newton Laboratories, Inc.	115edfbe-417b-08b3-e063-6394a90ae6ae	2024-02-14	Warnings	Exact identifier unii: U0NQ8555JD
Relaxing Legs	ACONITUM NAPELLUS, GNAPHALIUM POLYCEPHALUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RHUS TOX, VISCUM ALBUM	The Magni Company	800257d9-c0fb-4c71-a2c7-20602523e4ac	2024-02-08	Warnings	Exact identifier unii: U0NQ8555JD
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)	Deseret Biologicals, Inc.	6d934960-63c6-4536-bde3-38c26f8083dc	2024-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Sterile Water	STERILE WATER	Chartwell RX, LLC	3681eeaa-807a-47ca-9fbc-61c2b682800a	2024-02-01		Exact identifier unii: 059QF0KO0R
Throat Care	ECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUM	Newton Laboratories, Inc.	105975ec-82ea-dbfb-e063-6394a90a4fd1	2024-02-01	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	Proficient Rx LP	61daa681-05a0-4b2f-a6d0-c6fc1044f521	2024-02-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Ear Ringing	ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA	Newton Laboratories, Inc.	1043debe-8787-a2f5-e063-6294a90a2a66	2024-01-31	Warnings	Exact identifier unii: 660YQ98I10 unii: U0NQ8555JD
Ear Ringing	ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA	Newton Laboratories, Inc.	1045ab27-c4d5-fcbd-e063-6294a90a5176	2024-01-31	Warnings	Exact identifier unii: 660YQ98I10 unii: U0NQ8555JD
Tinnitus	ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA	Newton Laboratories, Inc.	10462aaa-96d4-4ba3-e063-6294a90a7915	2024-01-31	Warnings	Exact identifier unii: 660YQ98I10 unii: U0NQ8555JD
Sterile Water	WATER	A-S Medication Solutions	dba87371-31d2-47c2-ab83-89aabce4b184	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals,Inc.	fe08221d-74d5-490a-8db4-eaf3ed20b289	2024-01-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a14ca7d9-de30-a303-e053-2a95a90a5304	2024-01-27	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
BSS	BALANCED SALT SOLUTION	Alcon Laboratories, Inc.	4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea	2024-01-25	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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