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 67 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	73c911bb-4d39-4793-acba-90ed4b0eff46	2022-10-17	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Dr Talbots Infgant Gas Colic Relief	CARBO VEGETABILIS 12X,CHAMOMILLA 12X,FOENICULUM VULGARE 12X,LYCOPODIUM 30X,NUX MOSCHATA 12X,RAPHANUS SATIVUS 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6X	Talbot's Pharmaceuticals Family Products,LLC.	e8bee190-04b2-4be6-e053-2a95a90a30a0	2022-09-28	Warnings	Exact identifier unii: 660YQ98I10 unii: G0R4UBI2ZZ
Dr Talbots Infant Tummy Ache Relief	CALENDULA OFFICINALIS 12X,CARBO VEGETABILIS 12X,LYCOPODIUM 30X,FOENICULUM VULGARE 12X,NUX MOSCHATA 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6X	Talbot's Pharmaceuticals Family Products,LLC.	e9c24994-b935-36e6-e053-2a95a90a78df	2022-09-28	Warnings	Exact identifier unii: 660YQ98I10 unii: G0R4UBI2ZZ
Verbascum Thapsus	VERBASCUM THAPSUS	Hahnemann Laboratories, INC.	e9c5b157-c54c-789f-e053-2a95a90a7fce	2022-09-28		Exact identifier unii: C9TD27U172
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Dr Talbots Infant Mucus Cold Relief	EUPATORIUM PERF 12X,HEPAR SULPHURIS CALCAREUM 12X,KALI BICHROMICUM 12X,MARRUBIUM VULGARE 12X,PHOSPHORUS 30X,PULSATILLA 12X,RUMEX CRISPUS 12X,SAMBUCUS NIGRA 12X,CALCAREA SULPHURICA 12X,FERRUM PHOSPHORICUM 12X	Talbots Pharmaceuticals Family Products, LLC.	e8917c54-f4c2-3427-e053-2995a90adbf2	2022-09-13	Warnings	Exact identifier unii: 660YQ98I10
Dr Talbots Infant Pain Inflamtion Relief	ARNICA 12X,BELLIS PERENNIS 12X,CALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,COFFEA CRUDA 12X,HYPERICUM 12X,MILLEFOLIUM 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 6X	Talbots Pharmaceuticals Family Products, LLC.	e892c0cb-03b4-52da-e053-2995a90a0878	2022-09-12	Warnings	Exact identifier unii: 660YQ98I10 unii: G0R4UBI2ZZ
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Dr. Reddys Laboratories, Inc.	dda82a38-0c08-4947-99b7-915c2949bf16	2022-08-29	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Plantago Major	PLANTAGO MAJOR	Hahnemann Laboratories, INC.	e61531a6-8a74-5ec3-e053-2995a90a0a57	2022-08-12		Exact identifier unii: W2469WNO6U
ReBoost	APIS MELLIFERA, ATROPA BELLADONNA, ZINC GLUCONATE, BAPTISIA TINCTORIA ROOT, ULMUS RUBRA BARK, SULFUR, ZINC ACETATE ANHYDROUS,VINCETOXICUM HIRUNDINARIA ROOT AND CAIRINA MOSCHATA HEART/LIVER	MediNatura	d26137fa-6916-473a-9518-b0613e5cbcce	2022-08-08	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H
Potassium Chloride	POTASSIUM CHLORIDE	Actavis Pharma, Inc.	db002ae3-f54c-40a4-9cb4-e5681bf426e3	2022-08-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	Actavis Pharma, Inc.	ed5baaf6-270b-4dd3-b100-36030c0098fc	2022-08-01	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bronchial and Breathing Aide	ACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN	Schwabe Mexico S.A. de C.V	96feb2ec-e051-4bb9-bd43-70ad103cef5a	2022-07-26	Warnings	Exact identifier unii: U0NQ8555JD
Bronchial and Breathing Aide	ACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN	Schwabe North America, Inc	9cd140ec-8723-4635-8cec-646b61f0552e	2022-07-26	Warnings	Exact identifier unii: U0NQ8555JD
Kali Muriaticum	KALI MURIATICUM	Hahnemann Laboratories, INC.	e3c8e13d-a67d-162c-e053-2a95a90abd11	2022-07-14		Exact identifier unii: 660YQ98I10
KALIUM MURIATICUM 6X	POTASSIUM CHLORIDE	Seroyal USA	22c95b6a-dd5d-476e-e054-00144ff8d46c	2022-07-07	Warnings	Exact identifier unii: 660YQ98I10
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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