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 23 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	d3d29c8f-c326-4097-814a-7f4e08c67068	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	01721071-af03-4894-95c1-10b8bc64b888	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Dextrose in Lactated Ringers	DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	190da07e-a616-46e6-b4e5-1c0ba39306e5	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f4958	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	f6d82772-638c-4584-b9d3-8833669f5963	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	eb6b608f-5e51-4bc9-8339-c5d5264cba98	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	ICU Medical Inc.	d8ee14e9-6733-4813-9f21-2b043a5f7188	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	243fe8fc-996a-4855-8daf-069628e547c4	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	d310d170-5eeb-471b-af1a-0e845001d21d	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	237b39fa-916e-4a54-99c8-4ae9ad54f056	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Normosol-R and Dextrose	DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	ead1fca3-eff4-478f-8a8f-67510f80151a	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	0e089a44-0cee-4804-8f6f-8508508ddb5c	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride in Dextrose	DEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTION	ICU Medical Inc.	02d694b5-3600-4d55-bd5c-924abaec5315	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Ionosol MB and Dextrose	DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	ICU Medical Inc.	1b457b1d-0e80-4578-ba6f-dedf513fc962	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	189b8ac6-e346-454f-b501-7645590ca4f8	2025-10-29	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sterile Water	WATER	ICU Medical Inc.	1c0bbcb7-5ed6-4ee7-b297-080d3359474e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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