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 59 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymphastat B	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, FERRUM PHOSPHORICUM, LACHESIS MUTUS, PHOSPHORUS	Energique, Inc.	3a1f761e-eb12-41d8-b185-46da39497b08	2023-10-10	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Metab	CALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,	Nutritional Specialties, Inc.	bbed9973-238f-47c5-9a50-ac0869a7eb3a	2023-10-09	Warnings	Exact identifier unii: 660YQ98I10
Isolyte S pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE	B. Braun Medical Inc.	150437b6-320e-4c69-a434-2a26a1f0b2e4	2023-10-06	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
BHI Spasm Pain	ATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, AND CUPRIC SULFATE	MediNatura Inc	3e117ea6-bbb2-4b77-b3ce-01572e6d71c1	2023-09-28	Warnings	Exact identifier unii: U0NQ8555JD
T-Relief Extra Strength	CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT, ACONITUM NAPELLUS, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, ARNICA MONTANA, BELLIS PERENNIS AND HYPERICUM PERFORATUM	MediNatura Inc	01804104-32c2-4011-a2e4-0f4e74bd974d	2023-09-28	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
T-Relief Extra Strength Gel	ACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	e4bf2e39-5635-4797-8519-7e115e8b1a27	2023-09-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
T-Relief	ACHILLEA MILLEFOLIUM, HYPERICUM PERFORATUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA, UNSPECIFIED, MATRICARIA RECUTITA, ATROPA BELLADONNA,COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS,ARNICA MONTANA, AND RUTA GRAVEOLENS FLOWERING TOP	MediNatura Inc	1fcfd0a5-b4ff-4546-e054-00144ff8d46c	2023-09-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
T-Relief Extra Strength Cream	ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA UNSPECIFIED, ACONITUM NAPELLUS, ACHILLEA MILLEFOLIUM, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, BELLIS PERENNIS, RUTA GRAVEOLENS FLOWERING TOP, BAPTISIA TINCTORIA ROOT, COMFREY ROOT AND HYPERICUM PERFORATUM	MediNatura Inc	12f6cf2f-a924-42b1-9ca0-c360c7a59244	2023-09-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
T-Relief	ACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	edb2fe62-e990-4cef-8600-9d1b85bffa5a	2023-09-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Physiolyte	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	B. Braun Medical Inc.	19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e	2023-09-26	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Traumeel	ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOT	MediNatura Inc	c9962e63-3c30-4c62-9caf-91f663c7eeaa	2023-09-26	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	0631d5e5-9da4-bcb7-e063-6394a90a62de	2023-09-25	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
CardCare	ECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.	Newton Laboratories, Inc.	06342201-f0b4-de0d-e063-6294a90a5621	2023-09-25	Warnings	Exact identifier unii: U0NQ8555JD
Pancreas Sarcode	CHAMOMILLA, GLYCYRRHIZA GLABRA, SYZYGIUM JAMBOLANUM, VACCINIUM MYRTILLUS, ACETICUM ACIDUM, CONDURANGO, PHASEOLUS, SARSAPARILLA (SMILAX REGELII), PANCREAS SUIS, URICUM ACIDUM	Nutritional Specialties, Inc.	56a6dbc1-3a6b-444f-8082-1999a64e529c	2023-09-25	Warnings	Exact identifier unii: G0R4UBI2ZZ
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	e1670127-c551-441b-bac4-39f10a6d156f	2023-09-18	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
T-Relief Extra Strength	ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING, HAMAMELIS VIRGINIANA ROOT BARK/STEM, BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS, ECHINACEA, UNSPECIFIED, ACONITUM NAPELLUS, MATRICARIA CHAMOMILLA, ACHILLEA MILLEFOLIUM, ATROPA BELLADONNA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	97959b87-690d-45c1-9319-c17cdfa85020	2023-09-18	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	a9910e09-5aea-4ee1-a35e-ae4abf8b80b4	2023-09-07	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	f1af7e05-68ba-438e-a63b-cd8c23960c85	2023-09-06	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
AnubisMed	SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION	ANUBIS COSMETICS SL	e99d92c4-8768-9c0a-e053-2a95a90a609e	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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