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 11 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Humalog	INSULIN LISPRO	Eli Lilly and Company	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	2026-06-16	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
BM BM13	BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5447d1ed-f06b-9b6b-e063-6394a90ac981	2026-06-15	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BIO28 ALCOHOL	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	544b66c4-49df-556f-e063-6394a90af3ed	2026-06-15	Warnings	Exact identifier unii: 660YQ98I10
Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE	Wildman Business Group	1fd15b91-6b81-d0bd-e063-6294a90a4d27	2026-06-15	Warnings	Exact identifier unii: F5UM2KM3W7
BM BM128 DROPS	BAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REP	Total Operations Management LLC DBA:Bestmade Natural Products Micro	542363c9-f83b-b8e8-e063-6394a90a4e5a	2026-06-13	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM184 DROPS	BENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REP	Total Operations Management LLC DBA:Bestmade Natural Products Micro	542418a2-0538-42f1-e063-6294a90a649f	2026-06-13	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM97 DROPS	BRYONIA, IPECAC, JUNCUS EFF., KALI MUR, KALI SULPH, PHYTOLACCA DEC	BM Private Limited	540bcbc3-bb31-6ede-e063-6294a90a2bf6	2026-06-12	Warnings	Exact identifier unii: 660YQ98I10
GLOBAL CARE GOLD ANTIBACTERIAL HAND	BENZALKONIUM CHLORIDE	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	540bde3c-5af2-456a-e063-6294a90aa774	2026-06-12	Warnings	Exact identifier unii: F5UM2KM3W7
BM BM123 DROPS	AGARICUS MUS, VERBASCUM, GNAPHALIUM POLY, HYDROCOTYLE, PHOSPHOROUS, SPIGELIA	BM Private Limited	540cb0b9-20fc-97fc-e063-6294a90a6165	2026-06-12	Warnings	Exact identifier unii: C9TD27U172
BM BM128 DROPS	BAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REP	BM Private Limited	540ce573-fc39-e91b-e063-6394a90af73e	2026-06-12	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM184 DROPS	BENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REP	BM Private Limited	540d2953-a7fb-1621-e063-6294a90acb13	2026-06-12	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM11 DROPS	ACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARB	Total Operations Management LLC DBA:Bestmade Natural Products Micro	540ff544-b406-70e2-e063-6394a90ae451	2026-06-12	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM13 DROPS	BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	54103c3b-1974-b550-e063-6394a90a3145	2026-06-12	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM43 DROPS	CHAMOMILLA, CHELONE G., CINA, CINNABARIS, CUPRUM OXY. NIG., SANTONINE, TEUCRIUM MAR	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5410d802-d6b5-1fbe-e063-6294a90a95a3	2026-06-12	Warnings	Exact identifier unii: G0R4UBI2ZZ
BM BM70 DROPS	ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB	Total Operations Management LLC DBA:Bestmade Natural Products Micro	54113d1f-e8e7-6b4c-e063-6394a90a0edf	2026-06-12	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	REMEDYREPACK INC.	f75713cf-6902-4160-94cb-335a1ecdbbbe	2026-06-12	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
BM BM97 DROPS	BRYONIA, IPECAC, JUNCUS EFF., KALI MUR, KALI SULPH, PHYTOLACCA DEC	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5411cd7a-381d-ac21-e063-6394a90a5b91	2026-06-12	Warnings	Exact identifier unii: 660YQ98I10
BM BM123 DROPS	AGARICUS MUS, VERBASCUM, GNAPHALIUM POLY, HYDROCOTYLE, PHOSPHOROUS, SPIGELIA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5417ffd0-b5db-75a2-e063-6294a90a7500	2026-06-12	Warnings	Exact identifier unii: C9TD27U172
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	548953ac-31c5-a181-e063-6294a90a3b77	2026-06-12	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
V HP	ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR	Energique, Inc.	ea12ca3b-19e0-4d4a-9514-4d28d214e1e7	2026-06-12	Warnings	Exact identifier unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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