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 8 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	9088ca44-5585-4551-8e2c-168f306520d4	2026-03-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
B Force HP	APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA	BioActive Nutritional, Inc.	811c6f32-fcad-464c-bcf6-ae6a59195b1c	2026-03-30	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
Lymph Tonic I	ECHINACEA (ANGUSTIFOLIA), KALI IODATUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, HYPOPHYSIS SUIS, APIS MELLIFICA, ARANEA DIADEMA, BELLADONNA, CALCAREA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, GALIUM APARINE, GRAPHITES, LACHESIS MUTUS, MERCURIUS PRAECIPITATUS RUBER, MYRISTICA SEBIFERA, PHOSPHORUS, RHUS TOX, SCROPHULARIA NODOSA, SULPHUR, THYROIDINUM (SUIS), VESPA CRABRO	BioActive Nutritional, Inc.	9b9a639c-0a91-48b5-b1ff-6b82c6a568ef	2026-03-27	Warnings	Exact identifier unii: WQZ3G9PF0H
Cerebraplex	AVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, HYDROCOTYLE ASIATICA, POLYGONUM MULTIFLORUM, ROSMARINUS OFFICINALIS, VINCA MINOR, CEREBRUM SUIS, BARYTA CARBONICA, BELLADONNA, GERMANIUM SESQUIOXIDE, KALI PHOSPHORICUM, STRAMONIUM	BioActive Nutritional, Inc.	38905213-f20b-45d5-8e65-5f32e3839ea7	2026-03-27	Warnings	Exact identifier unii: WQZ3G9PF0H
Buffer pH	CHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIA	NaturalCare	2161a2e2-613d-4dac-a5f6-796d40e849d9	2026-03-25	Warnings	Exact identifier unii: G0R4UBI2ZZ
Potassium Chloride	POTASSIUM CHLORIDE	Ajenat Pharmaceuticals LLC	ab066a84-5455-419e-a1da-354a3f15a73d	2026-03-23	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Chamomilla Dec Cupro culta 3X	CHAMOMILLA DEC CUPRO CULTA 3X	Uriel Pharmacy, Inc	4d7af784-9f92-0dd5-e063-6394a90ab33b	2026-03-20	Warnings	Exact identifier unii: G0R4UBI2ZZ
Emotional Detox and Drainage	ACONITUM NAPELLUS, ADRENALINUM, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, CALCAREA SULPHURICA, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, CORTISONE ACETICUM, CROCUS SATIVUS, DNA, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI BROMATUM, LACHESIS MUTUS, PULSATILLA (PRATENSIS), THYROIDINUM (BOVINE), VIOLA ODORATA	Deseret Biologicals, Inc.	6b553600-5a90-4014-b02a-0992562bd229	2026-03-20	Warnings	Exact identifier unii: U0NQ8555JD
Sterile Water	WATER	Hospira, Inc.	2b9ea23a-f9e9-48a8-25b7-519e3bbd6828	2026-03-18	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Ear	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)	BioActive Nutritional, Inc.	82774eed-a906-4a19-86d9-05ea1462bd61	2026-03-18	Warnings	Exact identifier unii: W2469WNO6U unii: 660YQ98I10 unii: G0R4UBI2ZZ
Otoflam HP	BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLA	BioActive Nutritional, Inc.	12f1ef62-93f3-45b8-885d-1b82f85a8355	2026-03-17	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ
TINTED SUNSCREEN FOUNDATION	TINTED SUNSCREEN FOUNDATION	Guanghzou AiXin Biotech Co Ltd	396393c4-b50c-3877-e063-6294a90a0e9b	2026-03-17	Warnings	Exact identifier unii: 059QF0KO0R
SINUSCALM ALLERGY	ATROPA BELLADONNA. SPIGELIA ANTHELMIA. SANGUINARIA CANADENSIS ROOT	Boiron	4d3f554a-c8b2-3121-e063-6394a90a1598	2026-03-17	Warnings	Exact identifier unii: WQZ3G9PF0H
Bronchiforce	ALTHAEA OFFICINALIS, RHEUM (PALMATUM), VERBASCUM THAPSUS, LOBELIA INFLATA, BELLADONNA, CUPRUM ACETICUM, DROSERA (ROTUNDIFOLIA), IPECACUANHA, SPONGIA TOSTA, STICTA PULMONARIA	BioActive Nutritional, Inc.	c15e45a0-ba78-4572-88f1-7a35eeeb4abd	2026-03-17	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H
BM BIO17	CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.	BM Private Limited	4d22be93-c5f9-6ef3-e063-6294a90a7a8f	2026-03-16	Warnings	Exact identifier unii: 660YQ98I10
BM BIO10	CALC PHOS, FERR PHOS, KALI MUR.	BM Private Limited	4d271d53-5a12-3567-e063-6294a90a3757	2026-03-16	Warnings	Exact identifier unii: 660YQ98I10
Drainage	ECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR	BioActive Nutritional, Inc.	7e573986-60c2-40df-9e28-e7f1d9fe1a99	2026-03-13	Warnings	Exact identifier unii: 660YQ98I10
B-Force	ECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, PROTEUS (MORGANI), SALMONELLA TYPHI NOSODE, CLOSTRIDIUM PERFRINGENS	BioActive Nutritional, Inc.	0ccc9d9a-58d4-4957-91a3-4e8c04d1c86d	2026-03-11	Warnings	Exact identifier unii: WQZ3G9PF0H
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	2026-03-11	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Skin Irritations and Itch Relief	AGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.	King Bio Inc.	d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd	2026-03-10	Warnings	Exact identifier unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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