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 19 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AmazaPet	ALTHAEA, ARSENICUM ALB, INULA, KALI MUR, MAG PHOS	SILVER STAR BRANDS	b724bc91-d3e1-290e-e053-2a95a90a2625	2025-12-12	Warnings	Exact identifier unii: 660YQ98I10
GERM HP	APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE	Natural Creations, Inc.	15dc5391-0e6e-45d9-8ac7-142333a90716	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Germasode	ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRA	Natural Creations, Inc	cad24325-e658-4427-a2e7-f821f0111170	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H
GBLV HP	ATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, VERATRUM ALBUM ROOT	Natural Creations, Inc.	cff4d830-6696-4cde-9cd7-4ce55e28b54b	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H
HEADACHE HP	SILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIA	Natural Creations, Inc.	c38b83f0-3918-4ef6-8dfd-48fe438e584a	2025-12-12	Warnings	Exact identifier unii: WQZ3G9PF0H
Cell Well	CALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA	JoyWell Co LLC	592c1f48-21c8-4ff5-8818-046662c9effe	2025-12-11	Warnings	Exact identifier unii: 660YQ98I10
Throat Remedy	BELLADONNA 30C, HEAR SULPHURIS CALCAREUM 30C, LACHESIS MUTUS 30C, MERCURIUS SOLUBILIS 30C, PHYTOLACCA DECANDRA 30C, FERRUM PHOSPHORICUM 6X, KALI MURIATICUM 5X, CALCAREA SULPHURICA 6X, STREPTOCOCCINUM 200C	JoyWell Co LLC	51c00f80-3642-4552-a0f8-02a0f7495cf8	2025-12-11	Warnings	Exact identifier unii: 660YQ98I10 unii: WQZ3G9PF0H
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	ATLANTIC BIOLOGICALS CORP.	dc55474c-cc51-4f17-8cb3-0f34b3e68a55	2025-12-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
FLU HP	ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS ROOT	Natural Creations, Inc.	3d6c203a-6f30-4417-84d3-3cdab22098e3	2025-12-10	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
DIARRHEA CP	AETHUSA CYNAPIUM, ARSENIC TRIOXIDE, OYSTER SHELL CALICUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLOBILIS, PHOSPHORUS, PODOPHYLLUM, ANEMONE PULSATILLA, DELPHINIUM STRAPHISAGRIA SEED, SULFUR	Natural Creations, Inc.	06f51c41-1e76-4201-937a-cbaaf6a477af	2025-12-10	Warnings	Exact identifier unii: G0R4UBI2ZZ
Firstep Firstflush	EYEWASH	Encon Safety Products, Inc.	a44beb26-79ae-98bd-e053-2995a90a9b74	2025-12-09	Warnings	Exact identifier unii: 059QF0KO0R
Cartilago Betula	CARTILAGO BETULA	Uriel Pharmacy Inc.	99037dd6-b2c8-45d0-bb5f-670aed53ee46	2025-12-08	Warnings	Exact identifier unii: U0NQ8555JD
Cough and Bronchial	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN	Schwabe North America	791a8da1-0de3-4798-bbc9-b3538ea28dd7	2025-12-08	Warnings	Exact identifier unii: U0NQ8555JD
Cough and Bronchial Daytime Syrup	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN	Schwabe Mexico, S.A. de C.V.	e8949f67-1b05-40a2-96a5-d4d1124915ff	2025-12-08	Warnings	Exact identifier unii: U0NQ8555JD
Sambucus Flu Relief	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP	Schwabe North America, Inc.	ca7d57b0-ffae-415f-a959-b0c88ae7dd40	2025-12-08	Warnings	Exact identifier unii: U0NQ8555JD
Cough and Bronchial Nighttime Syrup	ACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN	Schwabe Mexico S.A. DE C.V.	00d38f6f-dbab-4bbd-84b5-9807ea9073f8	2025-12-04	Warnings	Exact identifier unii: U0NQ8555JD
V HP	ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR	Energique, Inc.	cba32ae8-45af-494c-ac1a-fea4b10f1860	2025-12-04	Warnings	Exact identifier unii: WQZ3G9PF0H
Nightime Cough and Bronchial	ACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN	Schwabe North America	b3899e48-2db8-4deb-b976-eb143b6223dd	2025-12-04	Warnings	Exact identifier unii: U0NQ8555JD
THE FLOWER REMEDY Peaceful Feeling	IMPATIENS GLANDULIFERA, HELIANTHEMUM NUMMULARIUM, AESCULUS HIPPOCASTANUM, PRUNUS CERASIFERA, MIMULUS GUTTATUS, POPULUS TREMULA, ACONITUM NAPELLUS	The Flower Remedy	13bf1fe0-5167-497a-9a0e-34e8f8e5230a	2025-12-03	Warnings	Exact identifier unii: U0NQ8555JD
BM BIO28 ICING SUGAR	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	3e855f3b-c73d-a153-e063-6394a90ad63a	2025-12-02	Warnings	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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