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 5 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
GUNA-KIDNEY	CHONDRODENDRON TOMENTOSUM ROOT - CLERODENDRANTHUS SPICATUS LEAF - EQUISETUM HYEMALE - ESCHERICHIA COLI - HIERACIUM PILOSELLA FLOWERING TOP - METHYLENE BLUE - NITRIC ACID - ONONIS CAMPESTRIS - PLANTAGO MAJOR - PORK KIDNEY - POTASSIUM NITRATE - PROTEUS VULGARIS - QUINHYDRONE - SARSAPARILLA - SOLIDAGO VIRGAUREA FLOWERING TOP - SUCCINIC ACID - SUS SCROFA URETER - SUS SCROFA URINARY BLADDER -	Guna spa	45c3c1af-e2b4-4239-98d9-f675c0e7d322	2026-06-11	Warnings	Exact identifier unii: W2469WNO6U
BM BM43 DROPS	CHAMOMILLA, CHELONE G., CINA, CINNABARIS, CUPRUM OXY. NIG., SANTONINE, TEUCRIUM MAR	BM Private Limited	53f8e154-d647-0064-e063-6294a90a3f6c	2026-06-11	Warnings	Exact identifier unii: G0R4UBI2ZZ
BM BM70 DROPS	ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB	BM Private Limited	53fa21d9-1f80-2e69-e063-6394a90ab9f3	2026-06-11	Warnings	Exact identifier unii: 059QF0KO0R
BM BM11 DROPS	ACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARB	BM Private Limited	53e7d586-805b-f1b3-e063-6294a90a118d	2026-06-10	Warnings	Exact identifier unii: WQZ3G9PF0H
BM BM13 DROPS	BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTA	BM Private Limited	53e86e23-8619-aef7-e063-6394a90ac38e	2026-06-10	Warnings	Exact identifier unii: WQZ3G9PF0H
GUNA-FLAM	ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -	Guna spa	7bda7eb0-8fd5-42d9-b336-39920bfc964d	2026-06-10	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
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	BM Private Limited	53d1c51a-77eb-bb3c-e063-6394a90aab3f	2026-06-09	Warnings	Exact identifier unii: 660YQ98I10
BM BIO17	CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53d39613-20bc-5877-e063-6394a90a0ee9	2026-06-09	Warnings	Exact identifier unii: 660YQ98I10
BM BM13	BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTA	BM Private Limited	53d42d09-d85e-64ee-e063-6294a90ab8ff	2026-06-09	Warnings	Exact identifier unii: WQZ3G9PF0H
BM Kali Mur	KALI MURIATICUM	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53ba82f3-be9f-51d7-e063-6394a90a877d	2026-06-08	Warnings	Exact identifier unii: 660YQ98I10
XIMONTH Fungi Free Bee Venom Nail Soothing Serum	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	53bab969-8407-6334-e063-6294a90aa5d1	2026-06-08	Warnings	Exact identifier unii: 059QF0KO0R
TERRAMED JUST THINK COMFORT GYNOCARE FOR BACTERIAL VAGINOSIS SYMPTOMS RELIEF	SODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,GOLDENSEAL,OLEA EUROPAEA OLIVE LEAF POWDER	Rida LLC	1625d88d-5ac8-492a-a152-3047d168575a	2026-06-08	Warnings	Exact identifier unii: MJ95C3OH47
Scrofularoforce	RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA	BioActive Nutritional, Inc.	737cd410-0405-41b0-b7f2-29bb20037849	2026-06-08	Warnings	Exact identifier unii: WQZ3G9PF0H
VAX	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,	BioActive Nutritional, Inc.	faa4a678-321a-4982-a5d4-01b713e6862d	2026-06-08	Warnings	Exact identifier unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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