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 48 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RUGBY EYE WASH	WATER, PURIFIED	A-S Medication Solutions	0773e558-2f46-494c-888a-3bc517202b65	2024-11-08	Warnings	Exact identifier unii: 059QF0KO0R
Finazol	FERROUS FUMARATE, FOLATE	PureTek Corporation	24290823-022a-433b-e063-6394a90a8fd0	2024-11-07	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Rage	ACONITUM NAPELLUS, ADRENALINUM, AGARICUS MUSCARIUS, APIS MELLIFICA, ATROPINUM, CAMPHORA, CANTHARIS, CAUSTICUM, CEREBRUM SUIS, CHAMOMILLA, CICUTA VIROSA, CUPRUM METALLICUM, HOMARUS, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, LAC CANINUM, MOSCHUS, STRAMONIUM, TARENTULA HISPANA, VERATRUM ALBUM	Deseret Biologicals, Inc.	5cbc13c2-9dfb-4178-b539-06c940c3f433	2024-11-06	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Earache Relief	BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)	The Magni Company	3f62001a-27b5-43cb-8006-110943facf87	2024-11-05	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Joint plus Tendon	ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, CARTILAGO SUIS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, RHUS TOX, THUJA OCCIDENTALIS	Liddell Laboratories, Inc.	64465f12-f50e-46ef-bb82-9b10b18cfa24	2024-11-04	Warnings	Exact identifier unii: U0NQ8555JD
Bladder Tone	BELLADONNA, CANTHARIS, CAUSTICUM, CINA, EQUISETUM HYEMALE, IGNATIA AMARA, PHYSALIS ALKEKENGI, PULSATILLA (PRATENSIS), SEPIA, VERBASCUM THAPSUS	Liddell Laboratories, Inc.	4b64399b-31f8-418a-b27d-a0b7a05de5ec	2024-11-04	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H
Overwhelmed	ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ANTIMONIUM CRUDUM, BARYTA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SILICATA, CICUTA VIROSA, CONIUM MACULATUM	Liddell Laboratories	e32ada10-9458-46b9-ba01-9200f53d7718	2024-11-04	Warnings	Exact identifier unii: U0NQ8555JD
Tension Headache	ACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUS	Liddell Laboratories, Inc.	6d49b251-bc9a-4383-a538-91d923e89148	2024-11-04	Warnings	Exact identifier unii: C9TD27U172 unii: U0NQ8555JD
Derma Pain	CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)	Liddell Laboratories, Inc.	e02a5e99-aa27-4276-a785-7b5328d89fdc	2024-11-04	Warnings	Exact identifier unii: W2469WNO6U
Nicotine Free	ABIES NIGRA, ACONITUM NAPELLUS, AVENA SATIVA, CALADIUM SEGUINUM, IGNATIA AMARA, LOBELIA INFLATA, LUNG SUIS, NUX VOMICA, PLANTAGO MAJOR, QUEBRACHO, STICTA PULMONARIA, TABACUM	Liddell Laboratories, Inc.	11580c55-cfe8-42d5-b2f4-ab9141c380ad	2024-11-04	Warnings	Exact identifier unii: W2469WNO6U unii: U0NQ8555JD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	96ea00f5-b922-4d57-b2ac-34523ea56d5f	2024-10-31	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Vertitone	BAPTISIA TINCTORIA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, COCCULUS INDICUS, CONIUM MACULATUM, PHOSPHORUS, PULSATILLA (PRATENSIS)	Energique, Inc.	12f1c465-b64a-446c-a28c-e96dabe03580	2024-10-31	Warnings	Exact identifier unii: WQZ3G9PF0H
Muscle/Tendon Pain and Stress Relief	CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)	Energique, Inc.	4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f	2024-10-29	Warnings	Exact identifier unii: W2469WNO6U
Ovapar	ANGELICA ARCHANGELICA, CAULOPHYLLUM THALICTROIDES, XANTHOXYLUM FRAXINEUM, OOPHORINUM (SUIS), APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, SEPIA, MUREX PURPUREA	Energique, Inc.	13ecc450-0ae3-46d3-8cc7-915c74c3361a	2024-10-29	Warnings	Exact identifier unii: WQZ3G9PF0H
Ototone	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)	Energique, Inc.	c34e0abf-02d8-4dee-a89b-3f61ab593dc3	2024-10-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Anxiovita	ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, CEREBRUM, HYPERICUM PERFORATUM	RUBIMED AG	258c677b-1a0a-4315-ba0c-4d9892f0534d	2024-10-29	Warnings	Exact identifier unii: U0NQ8555JD
Emvita 16	ACONITUM NAPELLUS, AMBRA GRISEA, ESCHSCHOLTZIA, SECALE, THYMUS GLAND, ZINC MET	RUBIMED AG	b681ec83-cc7f-4c8e-80a8-0aa0b1cc0759	2024-10-29	Warnings	Exact identifier unii: U0NQ8555JD
Emvita 20	APIS MELLIFICA, BELLADONNA, CANTHARIS, HYPOPHYSIS, IGNATIA AMARA, MAG CARB, PHOSPHORUS, PULSATILLA	RUBIMED AG	79aa12bc-4279-485f-9253-faacc4d2199c	2024-10-29	Warnings	Exact identifier unii: WQZ3G9PF0H
Emvita 21	ARSENICUM ALB, CHAMOMILLA, HYPOPHYSIS, LACHESIS MUTUS, MAG CARB	RUBIMED AG	46ddfe55-5189-4e43-9e30-44a33bb4a7a7	2024-10-29	Warnings	Exact identifier unii: G0R4UBI2ZZ
Emvita 24	CHAMOMILLA, CROTALUS HORRIDUS, HYPOPHYSIS, IGNATIA AMARA, PHOSPHORUS	RUBIMED AG	bea3529e-4757-433c-b005-999f2ed5ab32	2024-10-29	Warnings	Exact identifier unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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