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 18 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menopause HP	BELLADONNA, LACHESIS MUTUS, NUX VOMICA, PULSATILLA (VULGARIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDIS	BioActive Nutritional, Inc.	0f0aea3f-95d2-4a81-8180-cf675eeb7f62	2025-12-17	Warnings	Exact identifier unii: WQZ3G9PF0H
MENOPAUSE HP	ATROPA BELLADONNA, BLACK COHOSH, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, SEPIA OFFICINALIS JUICE, USTILAGO MAYDIS	Natural Creations, Inc.	38798520-1fcd-4494-b7b7-058633879abf	2025-12-16	Warnings	Exact identifier unii: WQZ3G9PF0H
Sleepy Time CP	ACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHUR	Natural Creations, Inc	03cbb408-7e2a-49e8-b83a-b8d932a10459	2025-12-16	Warnings	Exact identifier unii: U0NQ8555JD
Respirasode	BRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDIS	Natural Creations, Inc	ce06327f-7e5e-420a-9b61-0d410f9e10d6	2025-12-16	Warnings	Exact identifier unii: WQZ3G9PF0H
First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480bd260-3893-56e6-e054-00144ff8d46c	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Childrens First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480e73ed-b79e-6ada-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
EarAche Relief	APIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, TRIBASIC CALCIUM PHOSPHATE, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, MERCURIUS SOLUBILIS	TRP Company	e7813a36-4d1f-465e-9b76-1ab6b9f5b96f	2025-12-15	Warnings	Exact identifier unii: WQZ3G9PF0H
Animal First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	84628a32-7328-b71d-e053-2991aa0ae673	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Poultry First Aid	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	8464d4d1-6814-202f-e053-2991aa0a576b	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Skin Repair	ROSA CANINA, MATRICARIA RECUTITA, ARCHILLEA MILLEFOLIUM	Spry Life LLC	7bd56d39-83d0-3d55-e053-2a91aa0a571a	2025-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Cold Sore Relief	STELLARIA MEDIA, SALVIA OFFICINALIS, CALENDULA OFFICIALS, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	408119cb-6865-0b1b-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Foot Care	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480e32e4-42d1-606c-e054-00144ff8d46c	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
EarAche Relief PM	APIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALIS	TRP Company	92ee4f15-7315-7a46-e053-2995a90a7d0a	2025-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Poison Ivy Care	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480ee4ba-a92c-07ee-e054-00144ff8d46c	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Migraine Headache Therapy	ATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -	TRP Company	317d3f42-783e-02b7-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: WQZ3G9PF0H
Salvacine	CALENDULA OFFICIALS, PLANTAGO MAJOR, OLEA EUROPAEA, ACHILLEA MILLEFOLIUM	Spry Life LLC	e76594d6-7397-5d57-e053-2a95a90a99af	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U unii: MJ95C3OH47
Tattoo Care	CALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OIL	Spry Life LLC	480f0858-1f69-057c-e054-00144ff88e88	2025-12-15	Warnings	Exact identifier unii: W2469WNO6U
Ring Relief PM Nighttime Formula	ARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREA	TRP Company	92ef0dd1-84f9-086c-e053-2a95a90ac647	2025-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Swimmers Ear Complete Relief	CALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIAN	TRP Company	a3425da3-ace9-05c2-e053-2995a90ab09f	2025-12-15	Warnings	Exact identifier unii: 660YQ98I10
Respo-K	CALC SULPH, FERRUM PHOS, HEPAR SULPH CALC, SAMBUCUS NIG, VERBASCUM	SILVER STAR BRANDS	b727168c-0cb3-6a6a-e053-2995a90a0af0	2025-12-12	Warnings	Exact identifier unii: C9TD27U172

Reported adverse events (FAERS/openFDA)#

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