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 30 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	616f0de7-8843-44a1-8fa6-274d889286aa	2025-07-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
KLOR-CON	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	1ff53330-065c-4213-9c0c-ac498621d09d	2025-07-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
KLOR-CON	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	e61a4522-b91d-400a-952c-6f035e4610dd	2025-07-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
KLOR-CON M	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	b89910f6-4ff5-4a62-8269-696f7c10e4f6	2025-07-14	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sterile Water	STERILE WATER	Nephron Pharmaceuticals Corporation	bc04a883-babc-87a6-e053-2995a90a3dfd	2025-07-11	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
POTASSIUM CHLORIDE IN SODIUM CHLORIDE	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	ecc38772-246a-46c4-b42a-b9b81124f27f	2025-07-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-SmithLaboratories, LLC	ad584ce4-a64d-4851-80e9-0eeedc0b9d06	2025-07-10	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Schuessler Tissue Salts Kali Mur Glandular Tonic 5	KALI MURIATICUM	Martin & Pleasance Pty Ltd	4b2d8d03-c829-4292-ad94-993376d81b8f	2025-07-01	Warnings	Exact identifier unii: 660YQ98I10
Bac	APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDE	Zorex	7ae38e0c-8e74-4fd5-8605-45e424a84d01	2025-06-30	Warnings	Exact identifier unii: WQZ3G9PF0H
BM Natural Mullein Ear	BELLADONNA, CALENDULA, ECHINACEA, HYDRASTIS, MULLEIN OIL, VIOLA ODORATA	BM Private Limited	3890707a-d9b6-f1bd-e063-6394a90a3308	2025-06-27	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H
Cartilago Betula	CARTILAGO BETULA	Uriel Pharmacy Inc.	8c1e84ed-63a7-430c-b25c-06eaddad456b	2025-06-27	Warnings	Exact identifier unii: U0NQ8555JD
Rhus Aconitum	RHUS ACONITUM	Uriel Pharmacy Inc.	a3ef433e-fca5-45dc-a972-b0021e048c53	2025-06-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	b165ad93-1dc1-4863-9f0b-d7b97c42c94c	2025-06-23	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Plaque identifying	PLAQUE IDENTIFYING	Shenzhen Yagao Technology Co., Ltd.	37eeb656-22f1-7372-e063-6394a90ad041	2025-06-19	Warnings	Exact identifier unii: 059QF0KO0R
Sunshine YeastRelief	VAGINAL YEAST RELIEF	Apcco Labs, Inc	37de3347-7ad2-b9e7-e063-6394a90a90f4	2025-06-18	Warnings	Exact identifier unii: G0R4UBI2ZZ
Potassium Chloride ER	POTASSIUM CHLORIDE ER	Direct_Rx	377854ff-8034-c7ac-e063-6294a90a0817	2025-06-13	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Thyro T3 Rescue	SPONGIA TOSTA, IODIUM, FUCUS VESICULOSUS, BELLADONNA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, PARATHYROID GLAND (BOVINE), SELENIUM METALLICUM, THYROIDINUM (SUIS), HEPAR BOVINE, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, KIDNEY (SUIS), THYMUS (SUIS), LEVOTHYROXINUM, TRIIODOTHYRONINE	The Wellness Center for Research and Education	99070720-7f30-4f80-a0ab-3b5eea95a58f	2025-06-06	Warnings	Exact identifier unii: WQZ3G9PF0H
Serene Sleep	ESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOX	The Wellness Center for Research a	2d5bbd0d-9b50-45ce-aa23-05bd05b54645	2025-06-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
BioTox Dental Foci Repair	ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA	The Wellness Center For Research and Education	767f8dd2-759f-4662-9b5c-b8832309363d	2025-06-06	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H unii: U0NQ8555JD
PRISMASOL BGK2/0	MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE	Vantive US Healthcare LLC	7f675fee-8940-4ece-bb0c-75ac79d8708c	2025-05-31	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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