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 36 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bestmade Natural Products BM155	ARNICA, BELLADONNA, FERR PHOS, HAMAMELIS, IPECAC, KALI MUR, MILLEFOLIUM	Bestmade Natural Products	2e6b62c4-b088-136f-e063-6294a90a5fa2	2025-02-18	Warnings	Exact identifier unii: 660YQ98I10 unii: WQZ3G9PF0H
Bestmade Natural Products BM163	ANACARDIUM, KALI MUR, KALI SULPH, KALI BICH, KALI IOD, BARIUM IOD, POTHOS FOETIDA	Bestmade Natural Products	2e6db742-7f2d-ee6b-e063-6294a90aea2d	2025-02-18	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM165	GRINDELIA, ANGELICA ATRO, SILPHIUM LAC, BALSUM PER, KALI MUR, KALI BICH, KALI IOD, BARIUM MUR	Bestmade Natural Products	2e6e7960-b502-54c6-e063-6394a90add70	2025-02-18	Warnings	Exact identifier unii: 660YQ98I10
Advanced Eye Relief Eye Wash	WATER SOLUTION	Bausch & Lomb Incorporated	9caccce1-4530-441d-bf76-244edeb9dedc	2025-02-17	Warnings	Exact identifier unii: 059QF0KO0R
Belladonna 200ck	ATROPA BELLADONNA	SEVENE USA	c8d30961-fc0d-c8f1-e053-2995a90a2a8f	2025-02-11	Warnings	Exact identifier unii: WQZ3G9PF0H
Chamomilla 200ck	MATRICARIA RECUTITA	SEVENE USA	c8d5b230-9ef9-d1f4-e053-2995a90ac0e6	2025-02-11	Warnings	Exact identifier unii: G0R4UBI2ZZ
KALI MURIATICUM 6X	KALI MURIATICUM	SEVENE USA	ff0d279e-2109-6f8a-e053-6294a90a11dc	2025-02-11	Warnings	Exact identifier unii: 660YQ98I10
Muscle Ease	CHAMOMILLA, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARGENTUM NITRICUM, ARNICA MONTANA, BRYONIA, CHAMOMILLA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, EUPATORIUM PERFOLIATUM, HYPERICUM PERFORATUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STRAMONIUM, STRYCHNINUM.	Newton Laboratories, Inc.	9c5b8025-9c59-997e-e053-2a95a90ac6ce	2025-02-11	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Stage Fright-Fear	ACONITUM NAP., ANACARDIUM, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOS., SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANA	Newton Laboratories, Inc.	2df84360-dfff-9851-e063-6394a90ad790	2025-02-11	Warnings	Exact identifier unii: U0NQ8555JD
12 CELL SALTS COMPLEX	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA	SEVENE USA	ff0f69cd-97a2-7183-e053-6394a90ad039	2025-02-10	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM128	BAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REP	Bestmade Natural Products	2dccd761-a81f-8b72-e063-6394a90aba64	2025-02-10	Warnings	Exact identifier unii: WQZ3G9PF0H
Sciatica-Nerve Care	ACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA UR	Newton Laboratories, Inc.	9cbd3056-3c1a-916d-e053-2a95a90aa243	2025-02-10	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products BM130	BELLADONNA, CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS, THUJA	Bestmade Natural Products	2dcfe9c0-c677-541f-e063-6294a90a078a	2025-02-10	Warnings	Exact identifier unii: 660YQ98I10 unii: WQZ3G9PF0H
Sciatica-Nerve Care	ACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA UR	Newton Laboratories, Inc.	9cbda496-ef30-18af-e053-2995a90a2321	2025-02-10	Warnings	Exact identifier unii: U0NQ8555JD
Sports Recovery	ECHINACEA, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, APIS MELLIFICA, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CINCHONA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, LACTICUM ACIDUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STAPHYSAGRIA, SYMPHYTUM OFFICINALE	Newton Laboratories, Inc.	9cd61789-fc2b-3d54-e053-2995a90a5a34	2025-02-10	Warnings	Exact identifier unii: G0R4UBI2ZZ
Stress-Tension	CHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.	Newton Laboratories, Inc.	9d22bedb-9f9d-8421-e053-2a95a90acf4a	2025-02-10	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Swimmers Friend	ANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUS	Newton Laboratories, Inc.	9d260197-0c81-0df2-e053-2a95a90a4410	2025-02-10	Warnings	Exact identifier unii: C9TD27U172
Stress-Tension	CHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.	Newton Laboratories, Inc.	9d23e5da-4806-8ccc-e053-2995a90a1901	2025-02-10	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Teeth-Gums	CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA	Newton Laboratories, Inc.	9d27b1e4-a966-5495-e053-2a95a90a965b	2025-02-10	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Teeth-Gums	CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA	Newton Laboratories, Inc.	9d363a40-a17b-2b6f-e053-2a95a90a3384	2025-02-10	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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