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 78 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nausea CP	AETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHUR	Natural Creations, Inc	2746cde1-577b-41d6-9f22-93d8f1a2c235	2018-12-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
Nasal Decongestant	CAMELLIA SINENSIS, EPHEDRA VULGARIS, BELLADONNA, ARSENICUM ALBUM, CINNABARIS, KALI BICHROMICUM, PULSATILLA, SEPIA, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, SULPHUR	Natural Creations, Inc	938a25f8-e854-4537-a04d-5e2276199f5c	2018-12-21	Warnings	Exact identifier unii: WQZ3G9PF0H
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Novel Laboratories, Inc.	ce4d4d39-8551-4789-8347-af763635922c	2018-11-28	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: WQZ3G9PF0H
Potassium Chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	dded25a9-3df4-463a-8685-d2bc03ea4edb	2018-07-16	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bacteria Chord	AZADIRACHTA INDICA, BELLADONNA, BERBERIS VULGARIS, BOLDO, CANDIDA ALBICANS, CEANOTHUS AMERICANUS, CETRARIA ISLANDICA, CROTALUS HORRIDUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, HYPERICUM PERFORATUM, LAPPA MAJOR, LEDUM PALUSTRE, MILLEFOLIUM, MORBILLINUM, MYRRHA, PANCREAS SUIS, PERTUSSINUM, PHOSPHORUS, PLANTAGO MAJOR, PYROGENIUM, SOLIDAGO VIRGAUREA, ZINGIBER OFFICINALE	Energetix Corp	f12539de-a737-437e-9392-727208275ba1	2018-07-11	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H
HA HP	BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA	BioActive Nutritional, Inc.	30f6c191-ce6e-438c-9601-74f5e8b61f96	2018-07-06	Warnings	Exact identifier unii: WQZ3G9PF0H
EAR CARE EARACHE DROPS	ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR	Rite Aid Corporation	58f1f79f-f1dd-3094-e053-2991aa0ac591	2018-03-16	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Lactated Ringers	SODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	Baxter Healthcare Company	5215ec33-8cfe-4885-ae92-e6a12100bd27	2018-01-02	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
H-Rosacea Formula	BELLADONNA, NUX VOMICA	Healing Natural Oils LLC	f00b0028-4340-4219-8890-f66590a2a04d	2017-12-27	Warnings	Exact identifier unii: WQZ3G9PF0H
H-Joint and Muscle Formula	ARNICA MONTANA, BELLIS PERENNIS, CHAMOMILLA	Healing Natural Oils LLC	9f9ea8b1-2dd7-46b3-9f8f-5668f0279f00	2017-12-27	Warnings	Exact identifier unii: G0R4UBI2ZZ
H-Fissures Formula	CALENDULA OFFICINALIS, CHAMOMILLA	Healing Natural Oils LLC	aa2b25cc-5bf3-4aee-951f-497b8ae69f07	2017-12-27	Warnings	Exact identifier unii: G0R4UBI2ZZ
Homeoplex F	ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEA	Supplement Clinic, LLC.	a1872d34-7298-4016-b7b3-830ac1149126	2017-11-01	Warnings	Exact identifier unii: 660YQ98I10
Pertussis	ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXIN	Deseret Biologicals, Inc.	b50b5a93-dbb5-4be9-91ac-7513f0ee3410	2017-10-31	Warnings	Exact identifier unii: U0NQ8555JD
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardio Tonic	KALI MURIATICUM, KALI PHOSPHORICUM, PLANTAGO MAJOR, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, HEART (BOVINE), L-CARNITINE, L-VALINE, THYROIDINUM (SUIS), ABROTANUM (ARTEMISIA ABROTANUM), IODIUM, LECITHIN, SPIGELIA ANTHELMIA	BioActive Nutritional, Inc.	2c252ba6-f147-4c22-b432-cd603a9623ac	2017-08-14	Warnings	Exact identifier unii: W2469WNO6U unii: 660YQ98I10
Teething-HP	BORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEA	BioActive Nutritional, Inc.	1758624d-7ed8-49a6-ab24-2aab57703c91	2017-06-16	Warnings	Exact identifier unii: G0R4UBI2ZZ
Industrotox	GLYCYRRHIZA GLABRA, PLANTAGO MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ARNICA MONTANA, ASCLEPIAS TUBEROSA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, LAPPA MAJOR, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, SYMPHYTUM OFFICINALE, HEPAR SUIS, LUNG (SUIS), LYMPH NODE (SUIS)	BioActive Nutritional, Inc.	0722085a-1478-4667-b0c6-3315cff25b08	2017-06-16	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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