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 21 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	7289103a-5cbf-42f4-8848-e827149a43ca	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	b17d54ca-5885-48d3-96e9-b29ad14f8d76	2025-11-24	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Lymph HP	ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALE	Energique, Inc.	17aa9d9c-3d32-4963-91db-d1e96717e7ad	2025-11-24	Warnings	Exact identifier unii: U0NQ8555JD
Eyewash Additive Concentrate	WATER AND PROPYLENE GLYCOL	Haws Corporation	dd168403-398c-41ff-b1df-d93e4ff39de3	2025-11-20	Warnings	Exact identifier unii: 059QF0KO0R
ECZEMA	NICCOLUM SULPHURICUM, KALI BROMATUM, KALI MURIATICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, KALI SULPHURICUM, SULPHUR.	PLYMOUTH HEALTHCARE PRODUCTS LLC	624d8671-43ce-46a8-87d3-d491fd9ba913	2025-11-20	Warnings	Exact identifier unii: 660YQ98I10
Cold	BAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEA	Natural Creations, Inc	c45d1d8f-24be-4c13-8c4b-388962421415	2025-11-20	Warnings	Exact identifier unii: 660YQ98I10
Tension Headache	ACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUS	Liddell Laboratories, Inc.	897a3348-4d9d-4f74-a330-d6492baa4d03	2025-11-20	Warnings	Exact identifier unii: C9TD27U172 unii: U0NQ8555JD
COLD/FLU HP	ARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUM	Natural Creations, Inc.	11d945ea-3b03-42cc-b1c0-e4c517e386f6	2025-11-20	Warnings	Exact identifier unii: 660YQ98I10
Potassium chloride	POTASSIUM CHLORIDE	Advagen Pharma Ltd	8000e242-fe20-4d02-8f7d-97298857cf4c	2025-11-19	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	AvPAK	6bb3f62d-79ce-cee6-8c6c-ee1eb6121f01	2025-11-19	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	61fe55c2-fc9a-4fae-899a-06601baa78e1	2025-11-19	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Cartilago Argentum	CARTILAGO ARGENTUM	Uriel Pharmacy Inc.	0f3bf8ce-0a60-4a79-e063-6294a90a3932	2025-11-18	Warnings	Exact identifier unii: U0NQ8555JD
Sterile Water	WATER	Fresenius Kabi USA, LLC	fd823bef-c14c-4708-a18a-8aaa8470412f	2025-11-18	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Lavender Quartz Ear Oil	LAVENDER QUARTZ EAR OIL	Uriel Pharmacy Inc.	b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c	2025-11-17	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
BURN RELIEF	ARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUM	Natrural Creations, Inc.	79c80c6c-1fd9-4b32-81e0-ff6a1f610227	2025-11-13	Warnings	Exact identifier unii: WQZ3G9PF0H
BACK HP	ACONITUM NAPELLUS, HORSE CHESTNUT, COLCHICUM AUTUMNALE BULB, HYPERICUM PERFORATUM, MAGNESIUM PHOSPHATE DIBASIC TRIHYDRATE, LEAD, TOXICODENDRON PUBESCENS LEAF, ARNICA MONTANA	Natural Creations, Inc.	e589c7a2-0a7b-44ca-835d-ff25c6606152	2025-11-13	Warnings	Exact identifier unii: U0NQ8555JD
BELLA HP	ATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.	Natural Creations, Inc.	8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b1	2025-11-13	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
ANXIETY II HP	ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF	Natural Creations, Inc.	02fa45a5-08e1-41ad-acd4-0f85db07e89e	2025-11-13	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products USA, Inc.	3765c251-eb14-d60f-e063-6294a90a6a4d	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	37f244fd-c02f-e66a-e063-6394a90aed81	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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