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 12 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Sterile Soothing Eye Wash	PURIFIED WATER	Walgreens	a62e3294-abd6-48dc-81b1-62a809bdc968	2026-01-14	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Advagen Pharma Limited	d528c0c1-b81f-4f7a-8518-e6911b23c3eb	2026-01-13	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Insomnia Relief	INSOMNIA RELIEF	Homeocare Laboratories	22db7d8d-8611-4f8c-be47-af82a237f938	2026-01-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
Arthritis Relief	ARNICA MONTANA, BRYONIA ALBA, CHAMOMILLA,HYPERICUM PERFORATUM, KALMIA LATIFOLIA LEAF,KALMIA LATIFOLIA LEAF	Homeocare Laboratories	818cbfb4-b5f4-415c-ba9f-5305efe55953	2026-01-12	Warnings	Exact identifier unii: G0R4UBI2ZZ
COLD and FLU RELIEF	COLD AND FLU RELIEF	Clineva Management Services, LLC	544c918d-86cc-1f8d-e054-00144ff8d46c	2026-01-12	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Headache Relief	ATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARK	Homeocare Laboratories	47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f	2026-01-12	Warnings	Exact identifier unii: WQZ3G9PF0H
Menopause Relief	BARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDE	Homeocare Laboratories	99b182d5-4102-4b25-85d3-f4be077d753f	2026-01-12	Warnings	Exact identifier unii: WQZ3G9PF0H
AB	ACONITUM NAPELLUS, BRYONIA CRETICA	MARCO PHARMA INTERNATIONAL LLC	2d81c13f-102a-6741-e063-6294a90aee84	2026-01-12	Warnings	Exact identifier unii: U0NQ8555JD
ABC	ACONITUM NAPELLUS, BELLADONNA, CHAMOMILLA	MARCO PHARMA INTERNATIONAL LLC	44749e04-ca70-410d-a754-8befe8da11e7	2026-01-12	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
INFL Combination	ACONITUM NAPELLUS, ADENOVIREN NOSODE, BRYONIA (ALBA), EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM 2023-2024, IPECACUANHA, KREOSOTUM, VERATRUM VIRIDE	Deseret Biologicals, Inc.	d8d1d7b9-97f0-4b71-a589-af7c890a3160	2026-01-09	Warnings	Exact identifier unii: U0NQ8555JD
Lung Drainage	ANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDE	Deseret Biologicals, Inc.	fd109172-46c3-444e-9fa0-124f785c3fb5	2026-01-09	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	AvPAK	f32df7c0-33eb-e6d6-e053-2a95a90a2e8d	2026-01-09	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Baxter Healthcare Corporation	092ddee4-572d-4771-8d95-880cea01097e	2026-01-09	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Otitis Media Drops 2153	OTITIS MEDIA DROPS	Professional Complementary Health Formulas	9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172	2026-01-08	Warnings	Exact identifier unii: U0NQ8555JD
Cerebral Blood Stim Drops 2086	CEREBRAL BLOOD STIM DROPS	Professional Complementary Health Formulas	ee501d10-085e-4051-8702-587d4266cede	2026-01-08	Warnings	Exact identifier unii: U0NQ8555JD
Metex 6013	METEX	Professional Complementary Health Formulas	78371ca3-50a6-46f0-8ea6-7de57c516375	2026-01-08	Warnings	Exact identifier unii: W2469WNO6U
Cough Tonic 2995	COUGH TONIC	Professional Complementary Health Formulas	71d46da9-9e1d-43da-8664-b5579e9fd4e3	2026-01-08	Warnings	Exact identifier unii: U0NQ8555JD
Facial Pain Drops 2023	FACIAL PAIN DROPS	Professional Complementary Health Formulas	b23ed9f3-d230-467c-b8fa-c2a9a6f99f87	2026-01-08	Warnings	Exact identifier unii: U0NQ8555JD
Staph/Strep/Respiratory Nosode Combination 9418	STAPH/STREP/RESPIRATORY NOSODE COMBINATION	Professional Complementary Health Formulas	9981ec07-9bda-4789-9061-9e89de9ee8ed	2026-01-08	Warnings	Exact identifier unii: U0NQ8555JD
Difficulty Breathing Drops 2171	DIFFICULTY BREATHING DROPS	Professional Complementary Health Formulas	30bab475-47dd-4261-b497-1f8edf9dd411	2026-01-08	Warnings	Exact identifier unii: W2469WNO6U

Reported adverse events (FAERS/openFDA)#

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