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 35 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bestmade Natural Products BM241	BELLADONA, CEANOTHUS, CICUTA VIR, COCCULUS IND, GELSEMIUM, GRATIOLA	Bestmade Natural Products	2f84205f-a632-09bd-e063-6394a90a8940	2025-03-04	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products Belladonna	BELLADONNA	Bestmade Natural Products	2f863877-652f-91ef-e063-6294a90a96de	2025-03-04	Warnings	Exact identifier unii: WQZ3G9PF0H
Sambucus Cold Flu Relief Hot Drink Lemon Flavored	PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, SEMPERVIRENS, PHOSPHORUS	Universal Synergetics, Inc	2ca2064a-2011-48fb-a47a-837ea3fc9bf6	2025-03-04	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products BM218	ACONITE, HEPAR SULPH, SPONGIA, MOSCHUS, SAMBOCUS	Bestmade Natural Products	2f6f3f24-ceff-3194-e063-6394a90a72e4	2025-03-03	Warnings	Exact identifier unii: U0NQ8555JD
RexallEar Relief Ear Drops	MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR	Dolgencorp LLC	59cfc7b4-faf0-4794-8911-d8745e12c6b8	2025-02-28	Warnings	Exact identifier unii: G0R4UBI2ZZ
Meijer Ear Relief Ear Drops	CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR	Meijer Distribution Inc	8ff0fa61-964e-77a8-e053-2a95a90a2d3a	2025-02-28	Warnings	Exact identifier unii: G0R4UBI2ZZ
Potassium Chloride	POTASSIUM CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	bf632e1d-73f3-4df1-ad12-e555fa6a56e9	2025-02-27	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Genexa Kids Sleepology	ALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS	Genexa Inc.	ba0cd3c2-9883-9664-e053-2995a90a9fd4	2025-02-26	Warnings	Exact identifier unii: G0R4UBI2ZZ
AeroWash Eyewash	EYEWASH SOLUTION	Aero Healthcare US LLC	a477de08-4301-0ee5-e053-2995a90af79d	2025-02-26	Warnings	Exact identifier unii: 059QF0KO0R
Bestmade Natural Products BM197	RHUS TOX, BRYONIA, COLOCYNTHIS, ARSENICUM ALBUM, HYPERICUM, CHAMOMILLA, GNAPHALLIUM	Bestmade Natural Products	2ef5a641-e45a-bafc-e063-6394a90a1b5d	2025-02-25	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bestmade Natural Products BM201	ARS ALB, BRYONIA, CHAMOMILLA, COLOCYNTHIS, NUX VOMICA, RHUS TOX	Bestmade Natural Products	2ef7632e-dc8a-6b21-e063-6294a90ac2dd	2025-02-25	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bestmade Natural Products BM184	BENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REP	Bestmade Natural Products	2e9211e3-0e20-741e-e063-6394a90a4da1	2025-02-20	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM172	AURUM IOD, BELLADONNA, GUIACUM, HEPAR SULP, IODIUM, LAUROCERASUS, PHYTOLACCA DEC	Bestmade Natural Products	2e7d1eee-9290-17e0-e063-6394a90a9eb8	2025-02-19	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM176	ACONITE NAP, ARS ALB, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, LEDUM PAL, SULPHUR	Bestmade Natural Products	2e7e7a3c-5b60-20e2-e063-6294a90ae289	2025-02-19	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Bestmade Natural Products BM179	ACONITE, CACTUS GRAND, CRATAEGUS OXY, DIGITALIS PUR, GLONOINE, MAG PHOS, SPIGELIA, STROPHANTHUS	Bestmade Natural Products	2e818a28-a5cc-5c98-e063-6294a90a51f3	2025-02-19	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products BM180	ACONITE NAP, ARGENTUM NIT, CHAMOMILLA, CYCLAMEN, GELSEMIUM, IGNATIA, MAG MUR, MOSCHUS, NUX VOMICA	Bestmade Natural Products	2e8259e9-087f-8e19-e063-6294a90ab084	2025-02-19	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Bestmade Natural Products BM147	DULCAMARA, FERR PHOS, LYCOPODIUM, PLANTAGO MAJ, PULSATILLA, STIGMATA MAY	Bestmade Natural Products	2e696a0e-7767-d6cc-e063-6394a90aee89	2025-02-18	Warnings	Exact identifier unii: W2469WNO6U
Bestmade Natural Products BM151	BELLADONNA, BENZOIC ACID, CAUSTICUM, EQUISETUM, GELSEMIUM, RHUS AROM, VERBASCUM	Bestmade Natural Products	2e6a469d-026f-41b0-e063-6394a90abd79	2025-02-18	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H
Bestmade Natural Products BM148	BELLADONNA, COLOCYNTHIS, COLEUS AROM, DIOSCOREA VILL, LUPULINUM, RHUS TOX	Bestmade Natural Products	2e6a477a-c500-846a-e063-6294a90a1498	2025-02-18	Warnings	Exact identifier unii: WQZ3G9PF0H
Bestmade Natural Products BM152	ACONITE, ANTI TART, BELLADONNA, CYCLAMEN, DULCAMARA, SULPHUR	Bestmade Natural Products	2e6aa8e8-22fa-687f-e063-6394a90a3802	2025-02-18	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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