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 25 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Homeopathic Pick Up Drops	GELSEMIUM SEMPERVIRENS ROOT 12X, MATRICARIA CHAMOMILLA12X, ARNICA MONTANA WHOLE 12X,, PHOSPHORIC ACID 12X, ANEMONE PULSATILLA 12X, ACONITUM NAPELLUS 12X, STRYCHNOS NUX-VOMICA SEED 12X	HISTORICAL REMEDIES LLP.	0dfcc558-614d-4552-b45d-01402edcc4e9	2025-10-07	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Homeopathic Calm Drops	ARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30C	HISTORICAL REMEDIES LLP.	69c35bc2-b9a0-4bb4-a56d-0e2d1c3f7958	2025-10-07	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Homeopathic Moon drops	ARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,	Historical Remedies LLP	0e7972a5-a930-4a52-8896-02ce810fa90b	2025-10-07	Warnings	Exact identifier unii: G0R4UBI2ZZ
Homeopathic Stress Mints	AGRIMONIA EUPATORIA 3X, MATRICARIA CHAMOMILLA 12X, ARNICA MONTANA 12X, PHOSPHORIC ACID 12X, AVENA SATIVA FLOWERING TOP 3X, STRYCHNOS IGNATII SEED 12X, ANEMONE PULSATILLA 12X, ACONITUM NAPELLUS 12X, STRYCHNOS NUX VOMICA SEED 12X	Historical Remedies LLP	828d0f4d-915e-4340-bb98-62cd17eb970b	2025-10-07	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Sick Stopper	ECHINACEA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ARALIA QUINQUEFOLIA, BAPTISIA TINCTORIA, BRYONIA, CHELIDONIUM MAJUS, EUPATORIUM PERFOLIATUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS, SULPHUR, THUJA OCCIDENTALIS, BUFO RANA, NUX VOMICA, ANTHRACINUM, INFLUENZINUM, PYROGENIUM	Newton Laboratories, Inc.	016b7532-8cb6-df55-e063-6394a90abd75	2025-10-06	Warnings	Exact identifier unii: U0NQ8555JD
Influenseg	GALPHIMIA GLAUCA, CAUSTICUM, EUPATORIUM PERFOLIATUM, IPECACUANHA, ACONITUM NAPELLUS, KALI BICHROMICUM, AVENA SATIVA, INFLUENZINUM (2021-2022), LOBELIA PURPURESCENS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ECHINACEA (ANGUSTIFOLIA), CANCHALAGUA	Nucleic Products, LLC	48a07004-5b52-4be6-ac88-55725da06931	2025-10-06	Warnings	Exact identifier unii: U0NQ8555JD
Pyostat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ARSENICUM ALBUM, BELLADONNA, CROTALUS HORRIDUS, HYOSCYAMUS NIGER, LACHESIS MUTUS, PYROGENIUM, TARENTULA CUBENSIS, ANTHRACINUM	Energique, Inc.	427417ce-72a8-4d46-be24-b8b0fdc85458	2025-10-06	Warnings	Exact identifier unii: WQZ3G9PF0H
Topricin	AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFUR	Topical BioMedics, Inc.	321e83de-71e8-20b4-e054-00144ff8d46c	2025-10-03	Warnings	Exact identifier unii: WQZ3G9PF0H
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc15ef60-6956-4d34-b86d-72cdd0c0c0bb	2025-10-02	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Topricin	AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA, LACHESIS MUTUS, NAJA TRIPUDIANS, RHUS TOXICODENDRON, RUTA GRAVEOLENS	Topical BioMedics, Inc.	53f5778f-ab62-4dda-9bd9-8cc7fdd69d1e	2025-10-01	Warnings	Exact identifier unii: WQZ3G9PF0H
Potassium Chloride Extended-release	POTASSIUM CHLORIDE EXTENDED-RELEASE	Granules Pharmaceuticals Inc.	b3d4d5b5-2898-ae3d-e053-2a95a90a6d04	2025-09-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc	c1f4832d-4d5c-8c49-e053-2a95a90ac9fe	2025-09-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	0e875691-7372-46ac-80a1-946e08b40061	2025-09-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Xpect Eyewash	EYEWASH	Cintas Corporation	1d69365d-662b-4248-8fa9-1629451b549a	2025-09-30	Warnings	Exact identifier unii: 059QF0KO0R
CheBoho TEA TREE ACNE	CHEBOHO TEA TREE ACNE	Opalshi(Guangzhou)E-commerce Co. Ltd.	3fc4cf84-b2da-c593-e063-6394a90abc5c	2025-09-27	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Epic Pharma, LLC	00615fad-ad3b-46e8-a89d-48290d937ae2	2025-09-23	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Panic Ease	ACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.	Newton Laboratories, Inc.	9971a152-0706-8166-e053-2995a90aab9f	2025-09-23	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Potassium Chloride	POTASSIUM CHLORIDE	Macleods Pharmaceuticals Limited	89d827c8-91af-4bfd-a846-62e55824e983	2025-09-22	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	a9d68a40-75e3-4c5c-b5d7-1d6160527fa7	2025-09-22	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Sterile Water	WATER	ProPharma Distribution	3f2ae880-852f-b45d-e063-6394a90aa1cc	2025-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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