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 70 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OHM Fatigue Relief	ACETICUM AC, ADRENAL GLAND, ARNICA, BENZOICUM AC, FERRUM PHOS, FLUORICUM AC, GINSENG, KALI CARB, KALI LOD, KALI MUR, KALI PHOS, LACTICUM AC, PHOSPHORICUM AC, PICRICUM AC.	OHM PHARMA INC.	419c6315-37de-46b4-8bef-abbeace265b6	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10
OHM Fever Relief	ACONITUM NAP, BAPTISIA, BELLADONNA, BRYONIA, CHAMOMILLA, EUPATORIUM PERF, GELSEMIUM, RHUS TOX.	OHM PHARMA INC.	d55c1ef6-f682-4d06-ace7-2ed773e35f85	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Kids Cough Relief Syrup	ANTIMONIUM SULPHURATUM AUREUM, ANTIMONIUM TARTARICUM, BRYONIA ALBA, DROSERA ROTUNDIFOLIA, IPECACUANHA, KALI MURIATICUM, RUMEX CRISPUS, SENEGA OFFICINALIS, SPONGIA TOSTA.	OHM PHARMA INC.	b09a9fbc-15ad-4c60-bce8-e1097d241f2c	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10
Lyme Disease Support 2	ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.	OHM PHARMA INC.	13b4b78b-f9f7-4cf6-8f43-61679160086b	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10
Lyme Disease Support 1	ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.	OHM PHARMA INC.	035e75d6-aeef-4dfd-b076-9d3d8e4a5086	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10
OHM Mouthwash	ARNICA MONTANA, BORAX, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MYRRHA, PLANTAGO MAJOR, RATANHIA, SALVIA OFFICINALIS, SYMPHYTUM OFFICINALE.	OHM PHARMA INC.	4fa493ff-9ea2-4e17-9e16-994c11207440	2021-12-29	Warnings	Exact identifier unii: W2469WNO6U
OHM Muscle and Joint Pain Relief	ARNICA, ACONITUM NAP, ARNICA, BELLADONNA, BELLIS, CALC FLUOR, CALC PHOS, CALENDULA, ECHINACEA, HAMAMELIS, HYPERICUM, KALI MUR, LEDUM, MAG PHOS, RHUS TOX, RUTA, SYMPHYTUM.	OHM PHARMA INC.	c64eb2c5-fdde-4d68-bd5f-d892c64b0f5c	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10 unii: WQZ3G9PF0H unii: U0NQ8555JD
OHM Muscle and Joint Pain Relief Gel	ARNICA, ACONITUM NAP, ARNICA, BELLADONNA, BELLIS, CALC FLUOR, CALC PHOS, CALENDULA, ECHINACEA PURP, HAMAMELIS, HYPERICUM, KALI MUR, LEDUM, MAG PHOS, RHUS TOX, RUTA, SYMPHYTUM.	OHM PHARMA INC.	dec901c4-6a57-4151-8982-a9e256a48624	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10 unii: WQZ3G9PF0H unii: U0NQ8555JD
Cold	ACONITUM NAPELLUS, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, KALI LODATUM, ZINCUM GLUCONICUM.	OHM PHARMA INC.	12c71753-bed4-4f0c-970e-8564b2dd2e2e	2021-12-29	Warnings	Exact identifier unii: U0NQ8555JD
OHM Skin Healing Cream	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	c12e6706-37f0-4900-856c-fc7e7ac3b724	2021-12-29	Warnings	Exact identifier unii: G0R4UBI2ZZ
OHM Skin Healing Gel	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	f97dffe6-cddc-4577-afcc-deadb7abd0c6	2021-12-29	Warnings	Exact identifier unii: G0R4UBI2ZZ
OHM Sore Throat	ACONITUM NAP, AILANTHUS, BAPTISIA, BELLADONNA, FERRUM PHOS, HEPAR SULPH CALC, HYDRASTIS, MERC CYAN, MERC IOD RUB, PHYTOLACCA.	OHM PHARMA INC.	17d7c802-ed10-4cc9-8261-4f4888004b07	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
OHM Sting Relief and Insect Repellent	APIS MEL, ARNICA, BELLADONNA, CALADIUM, CALENDULA, GRAPHITES, LEDUM, PULSATILLA, RHUS TOX, STAPHYSAGRIA.	OHM PHARMA INC.	2ced7bbe-8275-462a-9218-6a516043caae	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H
OHM Tonic Syrup	ALFALFA, ARALIA QUIN (GINSENG), AVENA, CALC PHOS, CINCHONA, FERRUM PHOS, HYDRASTIS, KALI IOD, KALI MUR, KALI PHOS, MAG PHOS, NAT PHOS, NUX VOM, PHOSPHORICUM AC.	OHM PHARMA INC.	f3aca2b2-8df2-4995-91fd-c81c3286a0f8	2021-12-29	Warnings	Exact identifier unii: 660YQ98I10
Traulevium	BELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA.	Medical Technology Products, Inc.	6123d145-4edf-4ecd-8b30-196e52273127	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Traulevium	ARNICA MONTANA RADIX, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.	Medical Technology Products, Inc.	797f448f-a4c7-4c7a-980d-7c3b074e6499	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
TRAULEVIUM Pain Relief Drops	ARNICA RAD, ACONITUM NAP, CHAMOMILLA, BELLADONNA, SYMPHYTUM, BELLIS, CALENDULA, ECHINACEA, ECHINACEA PURP, HAMAMELIS, HYPERICUM, MILLEFOLIUM, HEPAR SULPH CALC, MERC SOLUB.	Medical Technology Products, Inc.	1f9efd2d-16e2-4c34-b62a-3745d3c53c6b	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Traulevium Pain Relief Gel	ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.	Medical Technology Products, Inc.	692daf7a-11e2-4f08-bdcf-1b9ac866d213	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Aconitum Napellus	ACONITUM NAPELLUS	OHM PHARMA INC.	3303816b-09f4-4b4a-a164-61de6825957b	2021-12-29	Warnings	Exact identifier unii: U0NQ8555JD
Belladonna	BELLADONNA	OHM PHARMA INC.	96bf1856-fa27-419f-a580-c57c63c4a41d	2021-12-29	Warnings	Exact identifier unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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