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 68 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Chamomilla	CHAMOMILLA	Hahnemann Laboratories, INC.	e006125d-f765-9e04-e053-2a95a90a4d81	2022-05-27		Exact identifier unii: G0R4UBI2ZZ
Alpha CF	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS,	Schwabe North America, Inc.	ea0e6d54-1a25-4300-8cea-0f7c56afded1	2022-05-03	Warnings	Exact identifier unii: U0NQ8555JD
ALPHA CF	ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS	Schwabe Mexico, S.A. de C.V.	26afa426-eaae-437f-85a7-3bf0ad3d361b	2022-05-03	Warnings	Exact identifier unii: U0NQ8555JD
Belladonna	BELLADONNA	Hahnemann Laboratories, INC.	dc15962b-4aef-f049-e053-2995a90ab195	2022-04-07		Exact identifier unii: WQZ3G9PF0H
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe Mexico, S.A. de C.V.	3e2e5f52-db54-4635-83a8-a67a683c093c	2022-03-22	Warnings	Exact identifier unii: 660YQ98I10
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe North America, Inc.	94de9ce3-6ee9-4322-bda2-0b4391f09d87	2022-03-22	Warnings	Exact identifier unii: 660YQ98I10
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da807eb3-34a3-61b9-e053-2995a90a0e21	2022-03-18	Warnings	Exact identifier unii: C9TD27U172 unii: W2469WNO6U unii: WQZ3G9PF0H
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da80a5ea-f603-719e-e053-2995a90a9710	2022-03-18	Warnings	Exact identifier unii: C9TD27U172 unii: W2469WNO6U unii: WQZ3G9PF0H
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da81b21a-090a-dabf-e053-2995a90aa05e	2022-03-18	Warnings	Exact identifier unii: C9TD27U172 unii: W2469WNO6U unii: WQZ3G9PF0H
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da821d05-b2f0-3582-e053-2a95a90afe59	2022-03-18	Warnings	Exact identifier unii: C9TD27U172 unii: W2469WNO6U unii: WQZ3G9PF0H
Cough - Airway	INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA	Newton Laboratories, Inc.	92ae84ae-559c-79b8-e053-2a95a90aa79f	2022-03-17	Warnings	Exact identifier unii: C9TD27U172
Cough - Airway	INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA	Newton Laboratories, Inc.	92aeb17c-8d05-a3b2-e053-2995a90a8626	2022-03-17	Warnings	Exact identifier unii: C9TD27U172
Cold - Sinus	INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA	Newton Laboratories, Inc.	7a433e80-087e-289c-e053-2a91aa0a9447	2022-03-17	Warnings	Exact identifier unii: C9TD27U172
Cold - Cough	INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA	Newton Laboratories, Inc.	98e7a385-aa56-f5fe-e053-2995a90a84d3	2022-03-17	Warnings	Exact identifier unii: C9TD27U172
Cold - Sinus	INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA	Newton Laboratories, Inc.	7a40e3b3-baa7-3ce8-e053-2991aa0a4d07	2022-03-17	Warnings	Exact identifier unii: C9TD27U172
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da717cf0-54af-c4e2-e053-2995a90ac97c	2022-03-17	Warnings	Exact identifier unii: C9TD27U172 unii: W2469WNO6U unii: WQZ3G9PF0H
VIRAL HP	ARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAF	Zorex International	1e1bed7c-4af9-4276-85a3-57ebe1d19d4b	2022-03-03	Warnings	Exact identifier unii: WQZ3G9PF0H
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	B. Braun Medical Inc.	ab67b151-8368-4321-b562-bad5eff7b740	2022-02-21	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Aconitum Napellus 200C	ACONITUM NAPELLUS	Natural Creations, Inc	91f429ad-10ef-45e0-b7f8-3c254d873cb5	2022-02-14	Warnings	Exact identifier unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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