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 72 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UNDA 22	ABSINTHIUM, ACONITUM NAPELLUS, ARGENTUM METALLICUM, BOLDO LEAF, CHAMOMILLA, COFFEA TOSTA, JATEORHIZA PALMATA, MANGANUM OXYDATUM NIGRUM, SALVIA OFFICINALIS	Seroyal USA	2044a04e-275f-3f16-e054-00144ff8d46c	2021-07-15	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Unda 42	ARNICA MONTANA, ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS, AURUM METALLICUM, CUPRUM METALLICUM	Seroyal USA	0cca91ac-7795-517c-e054-00144ff8d46c	2021-07-15	Warnings	Exact identifier unii: U0NQ8555JD
CARDUUS PLEX	BELLADONNA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHOLESTERINUM, CINCHONA SUCCIRUBRA, COLOCYNTHIS, LEPTANDRA VIRGINICA, LYCOPODIUM CLAVATUM, PODOPHYLLUM PELTATUM, TARAXACUM OFFICINALE	Seroyal USA	330fa208-69c2-6c37-e054-00144ff88e88	2021-07-14	Warnings	Exact identifier unii: WQZ3G9PF0H
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 660YQ98I10
Hemorrhoids	ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.	Newton Laboratories, Inc.	c6f30a27-ae7f-2574-e053-2995a90a9102	2021-07-12	Warnings	Exact identifier unii: W2469WNO6U
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	c67b3a39-ef78-5e81-e053-2a95a90a4786	2021-07-06	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	deb6b462-397f-4527-ae26-40dc5d5857bc	2021-04-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	d43beabe-b801-4319-ad36-9a80856b94bd	2021-04-29	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Dr. Talbots Vital 12	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC	Talbot's Pharmaceuticals Family Products, LLC	c10bb804-8169-63da-e053-2a95a90a8306	2021-04-28	Warnings	Exact identifier unii: 660YQ98I10
Breathe-Ease	ACONITUM NAPELLUS, ARSENIC TRIOXIDE, BLATTA ORIENTALIS, SOLANUM DULCAMARA TOP, IPECAC, NAPHTHALENE, QUEBRACHO BARK, PHOSPHORUS, HISTAMINE DIHYDROCHLORIDE	Homeocare Laboratories	bf644511-a052-c622-e053-2995a90afd80	2021-04-07	Warnings	Exact identifier unii: U0NQ8555JD
OHM-INMA	ACONITUM NAPELLUS, ARANEA DIADEMA, ARNICA MONTANA, ASCLEPIAS VINCETOXICUM, BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, EUPATORIUM PERFORLIATUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, JUGLANS REGIA, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SARSAPARILLA, SULPHUR, ZINCUM METALLICUM	OHM PHARMA INC.	bc8e72c7-b7e6-4d5d-bd37-75202244d440	2021-03-25	Warnings	Exact identifier unii: U0NQ8555JD
Hemorrhoids	ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.	Newton Laboratories, Inc.	c69eaaf5-b8d4-708b-e053-2a95a90ae6d1	2021-03-15	Warnings	Exact identifier unii: W2469WNO6U
Hemorrhoids	ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.	Newton Laboratories, Inc.	c69f4926-c5c9-63a0-e053-2a95a90a2ca6	2021-03-15	Warnings	Exact identifier unii: W2469WNO6U
GUNA SINUS PLUS	ALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA -	Guna spa	b48c5634-24cf-343e-e053-2995a90a3a9a	2021-02-17	Warnings	Exact identifier unii: W2469WNO6U
GUNA THROAT AND GUMS	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -	Guna spa	ba484531-ef7a-17ed-e053-2995a90a50b3	2021-02-17	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
GUNA HEALTHY BRAIN	CITRULLUS COLOCYNTHIS FRUIT PULP - UBIDECARENONE - SUS SCRIFA ADRENAL GLAND - SUS SCROFA PLACENTA - SELENIUM - THUJA OCCIDENTALIS LEAFY TWIG - CONIUM MACULATUM FLOWERING TOP - SUS SCROFA EMBRYO - ACONITUM NAPELLUS - ALOE - BARIUM OXALOSUCCINATE - SUS SCROFA CEREBRUM - ARNICA MONTANA - SUS SCROFA HYPOTHALAMUS -	Guna spa	ba486fa9-53d1-95d9-e053-2995a90af42d	2021-02-17	Warnings	Exact identifier unii: U0NQ8555JD
potassium chloride	POTASSIUM CHLORIDE	Zydus Pharmaceuticals (USA) Inc.	51586c47-1aff-4ce6-8030-89f9eb1bc9ac	2021-02-08	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
I-Sleep	ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA	Newton Laboratories, Inc.	c6a08752-db62-2187-e053-2a95a90af138	2021-02-01	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
I-Sleep	ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA	Newton Laboratories, Inc.	c6a1163c-b21e-6474-e053-2995a90a1750	2021-02-01	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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