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 82 of 136 · 2,711 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Behavior-Rite	ANACARD, CHAMOMILLA, CINA, THEA SINENSIS, VIOLA TRIC	Silver Star Brands	b78dbf3f-33fc-8613-e053-2a95a90ac7c2	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Shingles Remedy	CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA	Silver Star Brands	5d65c997-f5dc-4dee-e053-2a91aa0ac319	2025-01-01	Warnings	Exact identifier unii: W2469WNO6U
NativeRemedies Kidney Stone Clear	BELLADONNA,BERBERIS VULGARIS, CALC CARB, CANTHARIS, LYCOPODIUM	Silver Star Brands	f669d03b-52af-7f1b-e053-2a95a90a75c5	2025-01-01	Warnings	Exact identifier unii: WQZ3G9PF0H
Mucus-Clear Jr. Nighttime	CHAMOMILLA, CINA, KALI BIC, KALI CARB, KALI MUR, PULSATILLA	Silver Star Brands	830e4796-5371-f681-e053-2991aa0a8e83	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10 unii: G0R4UBI2ZZ
NativeRemedies Sciatigon M	ACONITUM NAPELLUS, BERBERIS VULGARIS, CHAMOMILLA, COLOCYNTHIS, MAGNESIA PHOSPHORICA, RHUS TOX.	Silver Star Brands	f69389b6-fbcb-49f0-e053-2a95a90a655f	2025-01-01	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
NativeRemedies Tic Tamer	CHAMOMILLA, CINA, HYOSCYAMUS, ZINC MET	Silver Star Brands	f76c2b90-d5fa-e765-e053-6394a90af57f	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Mucus Clear Allergy Relief	ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA	Silver Star Brands	f49bdcc1-1939-6dc2-e053-2995a90a0a3b	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Mucus-Clear Nighttime	HEPAR SULPH, KALI BIC, KALI CARB, KALI MUR, NUX VOM	Silver Star Brands	826c01f3-a8b6-48c7-e053-2a91aa0a3ce1	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Mucus Clear Cough and Cold Relief	ARG MET, ARSENICUM ALB, BAPTISIA, BRYPNIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, KALI MUR, MERC CORROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VAL.	Silver Star Brands	f4378d84-73d5-2170-e053-2a95a90a41c6	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Mucus-Clear Sinus Relief	BELLADONNA, HEPAR SULPH CALC, KALI BIC, PULSATILLA, SANGUINARIA, SPIGELIA ANTH	Silver Star Brands	c4459a80-3de7-504a-e053-2a95a90a337a	2025-01-01	Warnings	Exact identifier unii: WQZ3G9PF0H
Mucus-Clear	KALI BIC, KALI MUR, KALI SULPH	Silver Star Brands	c895c490-7ca1-dee6-e053-2995a90a2126	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Migraine Ease	BELLADONNA, BRYONIA, CIMICIFUGA, GELSEMIUM, GLONOINUM, IGNATIA, IRIS VERS, NUX VOM, SANGUINARIA, SEPIA, SPIGELIA ANTH	Silver Star Brands	c68ab321-7105-0e54-e053-2995a90a298a	2025-01-01	Warnings	Exact identifier unii: WQZ3G9PF0H
NativeRemedies Anger-Soothe	CHAMOMILLA, LYCOPODIUM, NUX VOMICA	Silver Star Brands	f67f7955-c4e9-64d7-e053-2995a90ac756	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Headache Ease	AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA	Silver Star Brands	c689fb16-6200-ac94-e053-2995a90a703d	2025-01-01	Warnings	Exact identifier unii: WQZ3G9PF0H
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Belly Calm	ARG NIT, ASAFOETIDA, CARBO VEG, CHAMOMILLA, LYCOPODIUM, MAG PHOS, NAT PHOS, NUX MOSCH, ZINGIBER.	Silver Star Brands	e661bbd8-6a1d-1019-e053-2995a90ae888	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Tula Tantrum Tamer	CHAMOMILLA, CINA	Silver Star Brands	bc2bd616-272f-94d0-e053-2a95a90a598e	2025-01-01	Warnings	Exact identifier unii: G0R4UBI2ZZ
Stress Away Anxiety Relief	ACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUM	Silver Star Brands	05e04129-e7c1-4e11-e063-6394a90a09ca	2025-01-01	Warnings	Exact identifier unii: U0NQ8555JD
Mucus-Clear Jr.	ALLIUM CEPA, FERRUM PHOS, KALI BIC, KALI CARB, KALI MUR	Silver Star Brands	83098e43-d89d-21ff-e053-2991aa0affde	2025-01-01	Warnings	Exact identifier unii: 660YQ98I10
Good Night Sleep	ACONITUM NAP,AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAG, VALERIANA	Silver Star Brands	9d5e8a6b-b908-26ee-e053-2995a90ae8c5	2025-01-01	Warnings	Exact identifier unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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