FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Ear Drops - Vitality Works, Inc | Vitality Works, Inc.Vitality Works, Inc | Vitality Works, Inc.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-050-01Pediatric Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID159
64616-050-02Pediatric Earache Remedy1 in 1 CARTONLIQUID19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-050PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]8Current NDC, Legacy NDC, 2 package rows20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RPEDIATRIC 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 4 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions30527e49-6648-44f3-97b2-9c51783ac0032026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals NY LLC590dd25c-c4cb-489a-a09b-eccbf1d37c1f2026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Leg CrampsACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOPHyland's Inc.fa0e82d1-0806-4256-82d2-8070336fbe1d2026-06-30WarningsExact identifier
unii: U0NQ8555JD
Terramed Just Think Comfort Homeopathic Vaginal Treatment for Yeast Infection Symptoms ReliefPULSATILLA PRATENSIS WHOLE,SODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,OLEA EUROPAEA OLIVE LEAFRida LLC08d6e79d-67a7-49af-a095-68ac402183112026-06-26WarningsExact identifier
unii: MJ95C3OH47
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: G0R4UBI2ZZ
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDESt. Mary's Medical Park Pharmacy549c9d28-bf8b-2dc2-e063-6294a90abe7b2026-06-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM13BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTATotal Operations Management LLC DBA:Bestmade Natural Products Micro5447d1ed-f06b-9b6b-e063-6394a90ac9812026-06-15WarningsExact identifier
unii: WQZ3G9PF0H
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 660YQ98I10
BM BM128 DROPSBAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REPTotal Operations Management LLC DBA:Bestmade Natural Products Micro542363c9-f83b-b8e8-e063-6394a90a4e5a2026-06-13WarningsExact identifier
unii: WQZ3G9PF0H
BM BM184 DROPSBENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REPTotal Operations Management LLC DBA:Bestmade Natural Products Micro542418a2-0538-42f1-e063-6294a90a649f2026-06-13WarningsExact identifier
unii: WQZ3G9PF0H
BM BM97 DROPSBRYONIA, IPECAC, JUNCUS EFF., KALI MUR, KALI SULPH, PHYTOLACCA DECBM Private Limited540bcbc3-bb31-6ede-e063-6294a90a2bf62026-06-12WarningsExact identifier
unii: 660YQ98I10
BM BM123 DROPSAGARICUS MUS, VERBASCUM, GNAPHALIUM POLY, HYDROCOTYLE, PHOSPHOROUS, SPIGELIABM Private Limited540cb0b9-20fc-97fc-e063-6294a90a61652026-06-12WarningsExact identifier
unii: C9TD27U172
BM BM128 DROPSBAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REPBM Private Limited540ce573-fc39-e91b-e063-6394a90af73e2026-06-12WarningsExact identifier
unii: WQZ3G9PF0H
BM BM184 DROPSBENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REPBM Private Limited540d2953-a7fb-1621-e063-6294a90acb132026-06-12WarningsExact identifier
unii: WQZ3G9PF0H
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro540ff544-b406-70e2-e063-6394a90ae4512026-06-12WarningsExact identifier
unii: WQZ3G9PF0H
BM BM13 DROPSBELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTATotal Operations Management LLC DBA:Bestmade Natural Products Micro54103c3b-1974-b550-e063-6394a90a31452026-06-12WarningsExact identifier
unii: WQZ3G9PF0H
BM BM43 DROPSCHAMOMILLA, CHELONE G., CINA, CINNABARIS, CUPRUM OXY. NIG., SANTONINE, TEUCRIUM MARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410d802-d6b5-1fbe-e063-6294a90a95a32026-06-12WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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