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 57 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Proficient Rx LP	d0ce0bdf-5f24-4093-813f-881c61d7fcc7	2024-01-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Leader Eye Wash	PURIFIED WATER	Cardinal Health	8d3ad11f-1945-f838-e053-2995a90a7aa5	2023-12-23	Warnings	Exact identifier unii: 059QF0KO0R
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Adare Pharmaceuticals Inc	22edb0e6-4e45-4e91-aead-3581cca293a0	2023-12-20	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Pain	ACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CARTILAGO SUIS, CAUSTICUM, CHAMOMILLA, COFFEA CRUDA, EUPHORBIUM OFFICINARUM, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PASSIFLORA INCARNATA, PYROGENIUM, RANUNCULUS BULBOSUS, SYMPHYTUM OFFICINALE	Liddell Laboratories, Inc.	b591e679-b481-47f1-8d4e-3f3040e9a42a	2023-12-19	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Belladonna	BELLADONNA	Energique, Inc.	1464f849-240b-415d-85db-50b21ff9f38b	2023-12-19	Warnings	Exact identifier unii: WQZ3G9PF0H
BSS	BALANCED SALT SOLUTION	Alcon Laboratories, Inc.	28488c7b-cf6a-4a03-916f-cc66b3afdc57	2023-12-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	5aa0adf8-7b84-4cb0-be31-5c3333a6cc44	2023-12-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	5c4b0be5-625e-435f-9d2c-9d8fb407a8ea	2023-12-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	d033c3b3-3ed6-4f23-a555-bae40cf0c48f	2023-12-05	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Eye Wash	WATER	Jiangxi Zhenmei Biological Technology Co.,Ltd	c68795b8-bf68-0d01-e053-2a95a90abebb	2023-12-04	Warnings	Exact identifier unii: 059QF0KO0R
Anger	ACONITUM NAPELLUS, ASAFOETIDA, CHAMOMILLA, CROCUS SATIVUS, HYOSCYAMUS NIGER, IGNATIA AMARA, STAPHYSAGRIA, VALERIANA OFFICINALIS	Liddell Laboratories	a427f6fe-606f-4248-8f9d-60aa4ba4765b	2023-12-01	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Back and Leg HP	ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, COLOCYNTHIS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PLUMBUM METALLICUM, RHUS TOX, ARNICA MONTANA	Energique, Inc.	45f8cdd2-d518-453a-8aa4-a0cb6b4e6eb0	2023-11-30	Warnings	Exact identifier unii: U0NQ8555JD
Renotox	TRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,	BioActive Nutritional, Inc.	b501f7bc-fa3a-494e-bf95-6779a3169a49	2023-11-17	Warnings	Exact identifier unii: 660YQ98I10
VERBASCUM THAPSUS	VERBASCUM THAPSUS	Boiron	85db9f12-3378-4001-e053-2a91aa0a9793	2023-11-15		Exact identifier unii: C9TD27U172
Potassium Chloride	POTASSIUM CHLORIDE	Sun Pharmaceutical Industries, Inc.	0a1f2f64-3b0b-5e5c-e063-6294a90a7185	2023-11-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Plantago major	PLANTAGO MAJOR	Boiron	8697b932-da5d-717e-e053-2a91aa0afcae	2023-11-14		Exact identifier unii: W2469WNO6U
Plantago major	PLANTAGO MAJOR	Boiron	690894f3-6dc6-6656-e053-2a91aa0a22ad	2023-11-14		Exact identifier unii: W2469WNO6U
Verbascum thapsus	VERBASCUM THAPSUS	Boiron	813fe1f4-645f-9de4-e053-2a91aa0a6973	2023-11-13		Exact identifier unii: C9TD27U172
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86093c75-6de0-bb16-e053-2991aa0ab6ef	2023-11-13		Exact identifier unii: 660YQ98I10
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86090ebb-0fb2-2c9c-e053-2a91aa0a0561	2023-11-13		Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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