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 39 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sniffles	ECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUM	Newton Laboratories, Inc.	9db425ca-f80d-46e9-e053-2a95a90addc4	2025-01-28	Warnings	Exact identifier unii: C9TD27U172 unii: U0NQ8555JD
Kali Muriaticum Kit Refill	POTASSIUM CHLORIDE	Washington Homeopathic Products	099223af-a3f6-c370-e063-6394a90aa17f	2025-01-28	Warnings	Exact identifier unii: 660YQ98I10
Fever-Infection	CHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUM	Newton Laboratories, Inc.	9d762268-8c30-8a86-e053-2a95a90a419c	2025-01-27	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Diarrhea	AESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUS	Newton Laboratories, Inc.	9d7322da-c2fb-0fc3-e053-2a95a90ac70b	2025-01-27	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Sniffles	ECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUM	Newton Laboratories, Inc.	9db1327c-6746-76cb-e053-2995a90a6e27	2025-01-27	Warnings	Exact identifier unii: C9TD27U172 unii: U0NQ8555JD
Olibanum Belladonna comp.	OLIBANUM BELLADONNA COMP.	Uriel Pharmacy, Inc	2c778131-9962-879a-e063-6394a90a56bb	2025-01-24	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM23	BELLADONNAD6, CAUSTICUMD7, EQUISETUMD5, KALI PHOSD5, PLANTAGO MAJD2, PULSATILLAD5	Bestmade Natural Products	edece1e9-1859-5422-e053-2995a90af1d0	2025-01-23	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H
Bestmade Natural Products BM24	ANACARDIUMD7, ASHWAGANDHAD2, BELLADONNAD7, GELSEMIUMD5, KALI PHOSD3, PHOSPHORUSD12, SEPIAD7	Bestmade Natural Products	ededa15e-1aa7-9d49-e053-2a95a90a0964	2025-01-23	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM34	ACONITED6, BELLADONNAD5, BRYONIAD7, FERR PHOSD7, IPECACD7, LACHESISD16, PHOSPHORUSD14	Bestmade Natural Products	ef2cb539-05f5-8a71-e053-2a95a90a3ac5	2025-01-23	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Bestmade Natural Products BM35	BELLADONNAD7, BRYONIA ALBAD7, CALC PHOSD6, COLCHICUMD16, COLOCYNTHISD7, DIOSCOREAD14, RHUS TOXD5	Bestmade Natural Products	ef2d0d21-5f21-bcfd-e053-2a95a90ae05e	2025-01-23	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM42	ACONITE NAPD2, BAPTISIA TINCD1, CHINA OFFD1, EUPATORIUM PERFD1, FILIPENDULA ULMD1	Bestmade Natural Products	ef920b7a-8fba-a4e7-e053-2995a90ac9b5	2025-01-23	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products BM46	ACONITE, BELLADONNA, CHAMOMILLA, MAG PHOS, MERC SOL, MILLEFOLIUM, STAPHYSAGRIA	Bestmade Natural Products	2c62e63a-fe82-a463-e063-6394a90a65ee	2025-01-23	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Bestmade Natural Products BM48	ARUM TRIP, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, MERC SOL, MORBILLINUM, PULSATILLA	Bestmade Natural Products	2c637fa2-f3b9-617e-e063-6394a90abdf2	2025-01-23	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products Kali Mur (Lactose-Free)	KALI MURIATICUM	Bestmade Natural Products	2c4ae2c0-6ba0-e1dc-e063-6294a90a0365	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products BM1	APIS MELLD4, BARYTA CARBD8, BELLADONNAD3, CALC IODD6, HEPAR SULPHD12, KALI BICHD4, LACHESISD12, MERCURIUSD8, PHYTOLACCAD4, SPONGIAD3	Bestmade Natural Products	eb63c669-8ac7-a40b-e053-2a95a90ad74c	2025-01-22	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products Bio4	CALC FLUOR, KALI MUR, NAT MUR, SILICEA	Bestmade Natural Products	ea224687-106e-3821-e053-2995a90aa69c	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Bestmade Natural Products Bio5	FERR PHOS, KALI MUR, NAT MUR, KALI SULPH	Bestmade Natural Products	ea22e5e7-491a-91ac-e053-2a95a90a4414	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride ER	POTASSIUM CHLORIDE ER	Direct_Rx	f988aa11-60ef-411e-e053-6294a90a522a	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Bestmade Natural Products Bio6	FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPH	Bestmade Natural Products	ea233792-038f-39e7-e053-2995a90a20ad	2025-01-22	Warnings	Exact identifier unii: 660YQ98I10
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Direct_Rx	946b9568-671d-172a-e053-2a95a90ac827	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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