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 58 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608a8de-8133-1d4b-e053-2991aa0a907a	2023-11-13		Exact identifier unii: 660YQ98I10
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	860887e7-7eaf-78c2-e053-2991aa0a9a75	2023-11-13		Exact identifier unii: 660YQ98I10
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86086aab-c411-7cf2-e053-2991aa0a81bd	2023-11-13		Exact identifier unii: 660YQ98I10
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608a379-c3b7-3053-e053-2a91aa0a2e65	2023-11-13		Exact identifier unii: 660YQ98I10
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608f3dd-31bf-0182-e053-2991aa0a1030	2023-11-13		Exact identifier unii: 660YQ98I10
Belladonna	ATROPA BELLADONNA	Boiron	850051dc-356f-33c5-e053-2a91aa0ae67d	2023-11-09		Exact identifier unii: WQZ3G9PF0H
Belladonna	ATROPA BELLADONNA	Boiron	84767820-0e29-3f25-e053-2a91aa0a6a18	2023-11-09		Exact identifier unii: WQZ3G9PF0H
Belladonna	ATROPA BELLADONNA	Boiron	b0b40260-79fe-11e6-9491-424c58303031	2023-11-09		Exact identifier unii: WQZ3G9PF0H
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals, Inc.	1f33bcfe-c28a-4800-9241-685d974a5d91	2023-11-08	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
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.	99eb7b5d-926d-aa16-e053-2a95a90a0834	2023-11-07	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD
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.	9c1edd83-5269-1363-e053-2a95a90a24dc	2023-11-03	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD
Anxiety	ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARCINOSIN, CAUSTICUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NITRICUM ACIDUM, PHOSPHORUS, RHUS TOX	Energique, Inc.	2fd7051b-d274-4028-8348-b175a22f045c	2023-11-03	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
ANTI AGE VEIN	ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CALCIUM FLUORIDE - CENTELLA ASIATICA - CINCHONA OFFICINALIS BARK - CRANBERRY - HORSE CHESTNUT - IRON - LACHESIS MUTA VENOM - MERCURY - PINEAPPLE - PULSATILLA VULGARIS - SUS SCROFA ARTERY - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - VISCUM ALBUM FRUIT - WITCH HAZEL -	Guna spa	fbb27858-9e40-40c6-8c42-9fb04890097e	2023-11-02	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Food Poisoning Detox	ECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, PODOPHYLLUM PELTATUM, ACONITUM NAPELLUS, COLOCYNTHIS, ARSENICUM ALBUM, COLIBACILLINUM CUM NATRUM MURIATICUM, SALMONELLA TYPHI NOSODE, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, ACONITUM LYCOCTONUM, CAMPYLOBACTER JEJUNI, CLOSTRIDIUM PERFRINGENS, LISTERIA MONOCYTOGENES	Nutritional Specialties, Inc.	9af75f01-ef40-4166-a02f-e08d49f3003e	2023-11-01	Warnings	Exact identifier unii: U0NQ8555JD
Thymus Sarcode	ECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS	Nutritional Specialties, Inc.	2dfda48f-5795-4b98-8bb2-bf65273e8920	2023-11-01	Warnings	Exact identifier unii: WQZ3G9PF0H
Insomnia	AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS	Liddell Laboratories, Inc.	18c15f17-1a16-4595-9d23-20353363cd72	2023-10-31	Warnings	Exact identifier unii: G0R4UBI2ZZ
SinusCalm	ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA	Boiron	95872748-6d70-5c80-e053-2995a90a570c	2023-10-30		Exact identifier unii: WQZ3G9PF0H
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	caaad470-7be1-11e6-b409-424c58303031	2023-10-16		Exact identifier unii: 660YQ98I10
Shallow Breathing Formula	ARALIA QUINQUEFOLIA, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, IPECACUANHA, BLATTA ORIENTALIS, ARSENICUM ALBUM, CUPRUM METALLICUM	Nutritional Specialties, Inc.	a470ffff-c479-4867-aa3f-f009032b26d7	2023-10-12	Warnings	Exact identifier unii: U0NQ8555JD
Lymphastat B	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, FERRUM PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, COLIBACILLINUM CUM NATRUM MURIATICUM, PYROGENIUM	Energique, Inc.	28df9ed4-28fa-4582-945b-18b31e73740a	2023-10-10	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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