NDC 64616-045-01 - 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: 64616-045
Requested NDC: 64616-045-01
Package NDCs from labels: 64616-045-01, 64616-045-02
Manufacturer: 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.	2025-12-17	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-045-01	Earache Remedy	15 mL in 1 BOTTLE, DROPPER	LIQUID	15		10
64616-045-02	Earache Remedy	1 in 1 CARTON	LIQUID	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-045	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20241212_49afb2c3-ee42-4be9-943a-36d73ded0004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
PLANTAGO MAJOR	ACTIVE INGREDIENT	W2469WNO6U	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
VERBASCUM THAPSUS	ACTIVE INGREDIENT	C9TD27U172	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
PLANTAGO MAJOR	ACTIVE MOIETY	W2469WNO6U	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
VERBASCUM THAPSUS	ACTIVE MOIETY	C9TD27U172	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]	2

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 127 of 134 · 2,668 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUNA HEALTHY BRAIN	CITRULLUS COLOCYNTHIS FRUIT PULP - UBIDECARENONE - SUS SCRIFA ADRENAL GLAND - SUS SCROFA PLACENTA - SELENIUM - THUJA OCCIDENTALIS LEAFY TWIG - CONIUM MACULATUM FLOWERING TOP - SUS SCROFA EMBRYO - ACONITUM NAPELLUS - ALOE - BARIUM OXALOSUCCINATE - SUS SCROFA CEREBRUM - ARNICA MONTANA - SUS SCROFA HYPOTHALAMUS -	Guna spa	ba486fa9-53d1-95d9-e053-2995a90af42d	2021-02-17	Warnings	Exact identifier unii: U0NQ8555JD
potassium chloride	POTASSIUM CHLORIDE	Zydus Pharmaceuticals (USA) Inc.	51586c47-1aff-4ce6-8030-89f9eb1bc9ac	2021-02-08	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
I-Sleep	ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA	Newton Laboratories, Inc.	c6a08752-db62-2187-e053-2a95a90af138	2021-02-01	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
I-Sleep	ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA	Newton Laboratories, Inc.	c6a1163c-b21e-6474-e053-2995a90a1750	2021-02-01	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
ER 911	ACONITUM NAP, APIS MEL, ARNICA, ARSENICUM ALB, BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, FERRUM PHOS, HISTAMINUM, HYPERICUM, IGNATIA, IMPATIENS GLAN FLOS, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS CERASIFERA, RHUS TOX, SULPHUR, SYMPHYTUM, VERTARUM ALB	Net Remedies	9daa0b2f-cfca-4a40-ae88-c38c7cd2db32	2021-01-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Visceral Polarity	ACONITUM NAP, ARG NIT, CHININUM PUR, ECHINACEA PURP, PLUM MET, SEPIA, SULPHURICUM AC	NET Remedies	971e74ea-f72f-403e-bc79-02901e5019e8	2021-01-21	Warnings	Exact identifier unii: U0NQ8555JD
Whole System EEP	MERCURIUS CORROSIVUS,NUX VOMICA,HYOSCYAMINUM,CARCINOSINUM,GRAPHITES,ZINCUM METALLICUM,LILIUM TIGRINUM,CINCHONA OFFICINALIS,CAUSTICUM,COFFEA CRUDA,BELLADONNA,IGNATIA AMARA,SCROPHULARIA NODOSA,SPONGIA TOSTA ,CEANOTHUS AMERICANUS,SENNA,HYDRASTIS CANADENSIS,CONDURANGO,CHELIDONIUM MAJUS,PITUITARY GLAND, BOS TAURUS,PANCREAS SUIS,LYCOPODIUM CLAVATUM,BERBERIS VULGARIS,	White Manufacturing Inc. DBA Micro-West	6fe11fe3-6725-4701-8461-25d4e885a6c4	2021-01-21	Warnings	Exact identifier unii: WQZ3G9PF0H
TOTAL PRO-JES	ADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONE	White Manufacturing Inc. BDA Micro-West	b26953f8-7b56-432c-958c-d80c528fbb6a	2021-01-21	Warnings	Exact identifier unii: WQZ3G9PF0H
Vermafuge -AG Lycopodium	NUX VOMICA,ARSENICUM ALBUM,CINCHONA OFFICINALIS,CAPSICUM ANNUUM,NITRIC ACID,MERCURIUSCORROSIVUS,BELLADONNA,CAJUPUTUM,LYCOPODIUM CLAVATUM,PHOSPHORUS,PHYTOLACCA DECANDRA,RHAMNUS PURSHIANA,FRAGARIA VESCA	White Manufacturing Inc. DBA Micro-West	447c7971-e7ea-4f47-82a2-ed6da883098f	2021-01-21	Warnings	Exact identifier unii: WQZ3G9PF0H
Anxiolix	ARSENICUM ALBUM ,SCUTELLARIA LATERIFLORA,PHOSPHORUS,LACHESIS MUTUS,PULSATILLA,PASSIFLORA INCARNATA,ACONITE,VALERIANA OFFICINALIS,CALCAREA CARBONICA,IGNATIA AMARA	White Manufacturing Inc. DBA Micro West	69660f20-c9ba-4b43-bc85-0fab3ff68c61	2021-01-21	Warnings	Exact identifier unii: U0NQ8555JD
BACTOFLAM	ECHINACEA,BAPTISIA,APIS MELLIFICA ,FERRUM PHOSPHORICUM ,	WHITE MANUFACTURING INC. DBA MICRO WEST	3bf75ef6-fc67-4edb-9ed3-204b6af021dd	2021-01-21	Warnings	Exact identifier unii: WQZ3G9PF0H
Wood	BELLADONNA, BERBER VULG, CARDUUS MAR, CHELIDONIUM MAJ, CHOLESTERINUM, COLOCYNTHIS, KALI CARB, NAT PHOS, NITRICUM AC, NUX VOM, PLATINUM MET, SEPIA	NET Remedies	95b44ad8-8091-420c-bf18-6e071bd6073b	2021-01-19	Warnings	Exact identifier unii: WQZ3G9PF0H
Water	ACONITUM NAP, ARSENICUM ALB, BORAX, CALC PHOS, GELSENIUM, LYCOPODIUM, PHOSPHORICUM AC, PICRICUM AC, PLUMB MET, SOLIDAGO	NET Remedies	3dc6fdf6-781c-4dec-9aab-a2237fc60c53	2021-01-19	Warnings	Exact identifier unii: U0NQ8555JD
PAIN RELIEF	ARNICA, CHAMOMILLA, HYPERICUM, IGNATIA, SYMPHYTUM	NET Remedies	75786c15-be49-4548-8f7a-319f86aa0cee	2021-01-19	Warnings	Exact identifier unii: G0R4UBI2ZZ
GUNA SLEEP SUPPORT	AVENA SATIVA FLOWERING TOP - CAFFEINE - MATRICARIA CHAMOMILLA WHOLE - PASSIFLORA INCARNATA FLOWERING TOP -POTASSIUM BROMIDE - ZINC VALERATE DIHYDRATE - SILVER NITRATE - STRYCHNOS INGATII SEED -	Guna spa	b3ffb7f9-fd2b-5f88-e053-2a95a90aa91c	2021-01-17	Warnings	Exact identifier unii: G0R4UBI2ZZ
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
OHM Mucus Relief	ANTIMONIUM CRUDUM, ANTIMONIUM TARTARICUM, CHELIDONIUM MAJUS, FERRUM PHOSPHORICUM, KALI CARBOONICUM, KALI MURIATICUM, KALI SULPHURICUM, MARRUBIUM VULGARE.	OHM PHARMA INC.	f13bff50-7087-46dc-a958-b460a2af6283	2021-01-11	Warnings	Exact identifier unii: 660YQ98I10
Real Relief	CHAMOMILA, COFFEA CRUDA, ERIODICTYON CALIFORNICUM, HISTAMINUM, IPECACUANHA, LOBELIA INFLATA, SAMBUCUS NIGRA, SOLIDAGO VIRGAUREA	GMP Laboratories of America, Inc.	b7a030d9-0644-4778-e053-2995a90a57c7	2020-12-29	Warnings	Exact identifier unii: G0R4UBI2ZZ
Poison Ivy	XEROPHYLLUM ASPHODELOIDES, ACONITUM NAP., ANACARDIUM ORIENTALE, APIS MEL., BRYONIA, CANTHARIS, CROTON, GRAPHITES, GRINDELIA, MEZEREUM, NUX VOM., RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP.,TARAXACUM, URTICA UR.	Newton Laboratories, Inc.	99e8ca63-4ec3-92a2-e053-2995a90ac9a6	2020-12-07	Warnings	Exact identifier unii: U0NQ8555JD
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	997474d5-4dc4-6104-e053-2995a90a03f1	2020-12-07	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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