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 38 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Panic Button	ACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.	Newton Laboratories, Inc.	9b308f64-ba16-8b4f-e053-2995a90ac3ec	2025-02-07	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Panic Button	ACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.	Newton Laboratories, Inc.	9b3f50f3-1397-da75-e053-2995a90a340c	2025-02-07	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Appetite - Craving Control	ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.	Newton Laboratories, Inc.	7964f0f7-7774-fac6-e053-2a91aa0a3e4a	2025-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Tummy Upset	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9dc307a2-4aa1-b02a-e053-2995a90a1788	2025-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Appetite - Craving Control	ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.	Newton Laboratories, Inc.	79655acc-f059-e509-e053-2a91aa0ac488	2025-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Dairy-Grain-Nightshades	IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.	Newton Laboratories, Inc.	9ba83c60-35be-181a-e053-2a95a90a9895	2025-02-06	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H
Ear Wax Build-Up	ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA	Newton Laboratories, Inc.	9302b838-6003-ba6a-e053-2995a90aedd3	2025-02-06	Warnings	Exact identifier unii: C9TD27U172 unii: 660YQ98I10
Fever - Infection	ANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	8f023019-5c58-e0de-e053-2a95a90accfd	2025-02-06	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Fever - Infection	ANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	91e5f7cb-9055-4708-e053-2995a90abdfa	2025-02-06	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Hangover Help	AGARICUS MUSC., ARSENICUM ALB., BISMUTHUM METALLICUM, BRYONIA, CAPSICUM, CARBO VEG., GLONOINUM, IPECAC., IRIS VERSICOLOR, LAUROCERASUS, LYCOPODIUM, MEZEREUM, NUX VOM., PULSATILLA, RANUNC. BULB. , THERIDION, VERATRUM ALB., ZINC. MET., ZINGIBER, CHAMOMILLA, PASSIFLORA, VALERIANA	Newton Laboratories, Inc.	9bcce2ee-42c2-29cf-e053-2a95a90a3639	2025-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
4 Kids Cold and Cough Nighttime	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL	Hyland's Consumer Health Inc.	71e93027-33c9-6147-e053-2a95a90aaa09	2025-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Baby Oral Pain Relief	OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA	Hyland' Inc.	5904f126-e8f0-a892-e053-2991aa0aef0f	2025-02-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Jacksons Cell Salts 12 IN 1	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA	Zettl Health Inc.	25ba49d0-0369-3666-e063-6294a90a71c4	2025-02-04		Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM63	CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADEN	Bestmade Natural Products	2cea4552-3700-3da3-e063-6294a90a14b5	2025-01-30	Warnings	Exact identifier unii: 059QF0KO0R unii: 660YQ98I10
Bestmade Natural Products BM79	CARDUUS MAR, HYDRASTIS, KALI MUR, PHYTOLACCIN, POLYGONUM, RUTA	Bestmade Natural Products	2cf029ac-5560-84fb-e063-6294a90a0620	2025-01-30	Warnings	Exact identifier unii: 660YQ98I10
Recovatone	GLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,	Energique, Inc.	8ca76872-a187-4fd8-8daf-9ee351bdf346	2025-01-28	Warnings	Exact identifier unii: 660YQ98I10
WHP Colds and Cough	ACONITUM NAPELLUS - ARSENIC TRIOXIDE - BRYONIA ALBA ROOT - PULSATILLA VULGARIS - STRYCHNOS NUX-VOMICA SEED	Washington Homeopathic Products	066df766-b1f5-83df-e063-6394a90aa588	2025-01-28	Warnings	Exact identifier unii: U0NQ8555JD
Bowel-Digestive Care	ECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALE	Newton Laboratories, Inc.	9d60d399-6f63-5842-e053-2995a90a7cf7	2025-01-28	Warnings	Exact identifier unii: C9TD27U172 unii: G0R4UBI2ZZ
WHP Headache	ATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEED	Washington Homeopathic Products	06d25564-4c7e-0b3a-e063-6294a90a38bf	2025-01-28	Warnings	Exact identifier unii: WQZ3G9PF0H
Tummy Upset	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9dc2da0a-0b3a-548e-e053-2995a90abe6d	2025-01-28	Warnings	Exact identifier unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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