FDA.reportPublic FDA data

NDC 64616-045-01 - 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
64616-045
Requested NDC
64616-045-01
Package NDCs from labels
64616-045-01, 64616-045-02
Manufacturer
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.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-045-01Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID1510
64616-045-02Earache Remedy1 in 1 CARTONLIQUID110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-045EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]9Current NDC, Legacy NDC, 2 package rows20241212_49afb2c3-ee42-4be9-943a-36d73ded0004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UEARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC.]2

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 41 of 139 · 2,773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediatric Earache RemedyEAR DROPSVitality Works, Inc5769ce2c-d2e1-4069-92cc-e38bee668daf2025-12-17WarningsExact identifier
unii: C9TD27U172
unii: W2469WNO6U
unii: 660YQ98I10
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
TLB-MatrixJOINT BOOSTERVitality Works, Inc.828aa3c0-b7f4-4169-92f1-6ef5f358e18a2025-12-17WarningsExact identifier
unii: WQZ3G9PF0H
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: W2469WNO6U
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 660YQ98I10
Cal-5-ReviveCALCIUM BALANCEVitality Works, Inc.a642c238-dacc-41a0-8590-ca466eb297892025-12-17WarningsExact identifier
unii: U0NQ8555JD
CL-NEMOTIONAL HEALTH BOOSTERVitality Works, Inc.0de1e383-f721-4d2c-a1e1-946371234b882025-12-17WarningsExact identifier
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
ndc (package): 64616-045-02
ndc (package): 64616-045-01
ndc (product): 64616-045
ndc11 (package): 64616004501
spl id: 462f5699-1583-e885-e063-6394a90abbc6
spl set id: 49afb2c3-ee42-4be9-943a-36d73ded0004
unii: C9TD27U172
unii: W2469WNO6U
unii: 660YQ98I10
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Gripe WaterGRIPE WATERVitality Works45ade734-f446-4370-e054-00144ff88e882025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Menopause HPBELLADONNA, LACHESIS MUTUS, NUX VOMICA, PULSATILLA (VULGARIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDISBioActive Nutritional, Inc.0f0aea3f-95d2-4a81-8180-cf675eeb7f622025-12-17WarningsExact identifier
unii: WQZ3G9PF0H
Kay Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.f71032b9-9c7e-458f-8859-4548dfd862172025-12-17WarningsExact identifier
unii: F5UM2KM3W7
SSDC Mystic Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.09899c40-6e4a-48a9-8d09-d374f6ab855f2025-12-17WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial and Sensitive AloeDIAL ANTIBACTERIAL AND SENSITIVE DEODORANT BAR SOAP HYPOALLERGENIC ALOE SCENTHenkel Corporation27c4d6fe-7562-073f-e063-6394a90afe9f2025-12-16WarningsExact identifier
unii: F5UM2KM3W7
Dial Professional Original Gold AntibacterialDIAL PROFESSIONAL ORIGINAL GOLD ANTIBACTERIAL HAND SOAPHenkel Corporation287965b6-5194-9d5c-e063-6394a90a4b682025-12-16WarningsExact identifier
unii: F5UM2KM3W7
I.C. Hand SanitizerBENZALKONIUM CHLORIDER&R Lotion, Inc.5361bb71-cc84-4a76-a0cf-2259a615baa42025-12-16WarningsExact identifier
unii: F5UM2KM3W7
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
unii: F5UM2KM3W7
MENOPAUSE HPATROPA BELLADONNA, BLACK COHOSH, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, SEPIA OFFICINALIS JUICE, USTILAGO MAYDISNatural Creations, Inc.38798520-1fcd-4494-b7b7-058633879abf2025-12-16WarningsExact identifier
unii: WQZ3G9PF0H
Sleepy Time CPACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHURNatural Creations, Inc03cbb408-7e2a-49e8-b83a-b8d932a104592025-12-16WarningsExact identifier
unii: U0NQ8555JD
RespirasodeBRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDISNatural Creations, Incce06327f-7e5e-420a-9b61-0d410f9e10d62025-12-16WarningsExact identifier
unii: WQZ3G9PF0H
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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