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 27 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GaviLyte - C TM	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK	Lupin Pharmaceuticals,Inc.	a8b15625-ca7c-4d57-9f36-3ac2a6d13665	2025-09-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Cold Flu Relief Berry	COLD FLU RELIEF BERRY	Schwabe North America	03241f9f-8188-48ed-9177-42ef1e6c0fd6	2025-09-10	Warnings	Exact identifier unii: U0NQ8555JD
GAVILYTE G TM	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	Lupin Pharmaceuticals,Inc.	3978822b-6473-4072-9f80-20ceb9bea355	2025-09-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Preferred Pharmaceuticals Inc.	87f369cf-40e5-4f91-aa42-ae986fce6544	2025-09-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Schuessler Tissue Salts Comb 12 General Tonic	CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA	Martin & Pleasance Pty Ltd	9083a01b-2fbe-4e04-9eec-bf4f65950ec7	2025-09-09	Warnings	Exact identifier unii: 660YQ98I10
Schuessler Tissue Salts Comb 12 General Tonic	CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA	Martin & Pleasance Pty Ltd	c14c79ab-85bb-45f2-83d1-1d9c298ffdfd	2025-09-08	Warnings	Exact identifier unii: 660YQ98I10
Medi-First First Aid Eye Wash	PURIFIED WATER	Unifirst First Aid Corporation	dcd7fe56-ff5c-4c8d-a415-6e363d7e53f4	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
Green Guard First Aid Eye Wash	WATER	Unifirst First Aid Corporation	a4ba5526-b4e2-4bcc-9127-aa22ebf5017f	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
Medi-First Plus First Aid Eye Wash	WATER	Unifirst First Aid Corporation	d7ea80ca-b4a0-4476-8b50-b3425c6d456a	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
ECOLAB Eye Wash	PURIFIED WATER	ECOLAB Food Safety Specialties, Inc.	4bcfa21a-791e-4d04-e054-00144ff88e88	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
Arnica Echinacea	ARNICA ECHINACEA	Uriel Pharmacy, Inc	3e4e07c5-6947-a502-e063-6294a90ab866	2025-09-08	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Physicians Care Eyewash	EYEWASH	Acme United Corporation	3e239b12-9a75-339d-e063-6294a90a72ae	2025-09-06	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a4	2025-09-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Polyethylene Glycol 3350 and electrolytes - Unflavored	POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED	Strides Pharma Science Limited	48c741a9-9039-4fdb-a875-86d4ea968282	2025-09-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dfa63fc-f8de-f1e0-e063-6294a90a8d47	2025-09-04	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dfac7ca-2c2e-e709-e063-6394a90adbb3	2025-09-04	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Kesin Pharma Corporation	440dcbbb-bb31-d3fd-e063-6294a90ab2f7	2025-09-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored	POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED	Strides Pharma Science Limited	37c111ec-5b62-42b9-bbb2-3b0c530e34c9	2025-09-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sterile Water	WATER INJECTION	Henry Schein, Inc.	3501952b-b556-4d5e-b81b-5c35ff87b475	2025-08-28	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	8f6ea056-5e10-4de1-97f0-55f0655a6f78	2025-08-27	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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