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 40 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bestmade Natural Products BM7	ECHINACEAD5, GRAPHITESD10, HYDROCOTYLED3, KALI MURD6, PETROLEUMD12, SULPHURD7, VIOLA TRICOLORD5	Bestmade Natural Products	ec16dd97-9407-5aef-e053-2a95a90af5b0	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products Bio9	FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS	Bestmade Natural Products	ea4dbb5b-9a48-0710-e053-2995a90ae388	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products Bio10	CALC PHOS, FERR PHOS, KALI MUR	Bestmade Natural Products	ea63db39-136e-6098-e053-2995a90aa618	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM9	BARYTA CARBD10, BELLADONNAD10,CISTUS CAND10, CONIUM MACD8, MERC. SOLD12, SARSAPARILLAD8, SCROPHULARIAD4	Bestmade Natural Products	ec57b104-abf4-11e7-e053-2a95a90abf50	2025-01-22	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products Bio11	FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULF	Bestmade Natural Products	eaa202d7-4297-57ba-e053-2995a90a0295	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM11	ACID SALICYLICUMD12, BELLADONNAD4, COFFEA CRUDAD5, GELSEMIUMD4, IRIS VERSD3, MELILOTUS OFFD4, SPIGELIAD3, USNEA BARBD2	Bestmade Natural Products	ec7ed4a0-e806-8c6f-e053-2995a90aa9f5	2025-01-22	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM13	BELLADONNAD4, CUPRUM ACETICUMD6, DROSERAD3, GRINDELIAD4, PECACD5, LOBELIA INFLATAD2. NAPHTHALINUMD12, YERBA SANTAD4	Bestmade Natural Products	ec7fd64f-2068-9223-e053-2995a90a9c1e	2025-01-22	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM17	ACONITED7, AGARICUS MUSD6, ANACARDIUMD7, GELSEMIUMD5, IGNATIAD5, MOSCHUSD12, PASSIFLORAD1	Bestmade Natural Products	ecfb7013-8dd6-66c1-e053-2a95a90a0301	2025-01-22	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products BM18	BELLADONNAD3, BELLIS P.D6, EUPHRASIAD6, FERR PHOSD6, PASSIFLORAD4, PHYSOSTIGMAD4, RUTA GRAVED3	Bestmade Natural Products	ed08b690-f908-6d2f-e053-2a95a90af51c	2025-01-22	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products Bio17	CALC FLUOR, KALI PHOS, FERR PHOS, KALI MUR	Bestmade Natural Products	eac2ec50-08e3-1923-e053-2a95a90aca1a	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Nuby Soothing Gel	SOOTHING GEL	NINGBO RAFFINI IMPORTS & EXPORTS CO LTD	290692c0-54d9-d401-e063-6294a90a705a	2025-01-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
PTS/Stress Remedy	ACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANA	Deseret Biologicals, Inc.	61111d6e-2480-4e89-bb0e-d712f044bdc7	2025-01-20	Warnings	Exact identifier unii: U0NQ8555JD
Medics Choice Soothing Eye Wash	PURIFIED WATER	KC Pharmaceuticals, Inc.	10e49808-161e-f4ec-e063-6294a90a1775	2025-01-19	Warnings	Exact identifier unii: 059QF0KO0R
Hydration Complex	BETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALE	Deseret Biologicals, Inc.	f60a2ab8-4146-4995-9bc6-be2660b17540	2025-01-16	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE EXTENDED-RELEASE	NCS HealthCare of KY, LLC dba Vangard Labs	c684758c-16f0-4bd9-b719-1aae64b7907f	2025-01-16	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Celeragesic	ECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM	Deseret Biologicals, Inc.	1a3edb9d-e571-4275-b56e-d2489da11e76	2025-01-14	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
D-4	QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAF	DNA Labs, Inc.	45577059-73f4-4302-b299-3e356aaf959a	2025-01-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
D-8	SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIA	DNA Labs, Inc.	bc817ccf-f11c-4875-9e14-5a249f92c503	2025-01-13	Warnings	Exact identifier unii: U0NQ8555JD
D-34	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLA	DNA Labs, Inc.	607e21a3-2229-48fa-b12c-ebd3130b9996	2025-01-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
D-6	ACONITUM NAPELLUS, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, CAUSTICUM, CAMPHOR (NATURAL), EUCALYPTUS GLOBULUS LEAF, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, AND SCHOENOCAULON OFFICINALE SEED	DNA Labs, Inc.	27f58993-c611-4dc7-ac8e-0132f0a4fcef	2025-01-13	Warnings	Exact identifier unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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